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2019 Veeva R&D Summit Keynote: Veeva Vision
Veeva Systems Inc
/@VeevaSystems
Sep 12, 2019
This.ai offers specialized consulting. The discussion of clinical data management, regulatory compliance (e.g. This video explores Veeva's vision for an integrated "Development Cloud" for the life sciences R&D sector, delivered through a keynote address at their 2019 R&D Summit. The speaker outlines Veeva's core vision to build an industry-specific cloud for life sciences, encompassing applications, data, professional services, and an ecosystem of partners, all aimed at improving and extending human life. Key themes include Veeva's foundational values ("do the right thing," customer success, employee success, speed) and significant product innovations across various R&D domains. The presentation details advancements in clinical data management (e.g., agile study design, autosave), the introduction of Vault Safety for pharmacovigilance, and the development of "Safety AI" to automate the processing of unstructured safety content. Other innovations include continuous publishing for regulatory submissions, enhanced collaborative authoring capabilities through Microsoft Word integration, and a complete quality suite (Quality Docs, QMS, Training). The speaker emphasizes the importance of integration via "Spark" technology to connect various Vaults and external systems, and the necessity for customers to embrace business process changes alongside new technology adoption. Key Takeaways: * **Integrated Development Cloud Strategy:** Veeva is pursuing a comprehensive "Development Cloud" strategy, aiming to provide an integrated suite of modular applications that serve as the "operating system for drug development," covering clinical, safety, regulatory, and quality functions to break down silos. * **Strategic AI Investment in Pharmacovigilance:** Veeva is making a significant move into AI with "Safety AI," a specialized product designed to process unstructured content (PDFs, emails, text) using an AI engine to generate review-ready safety cases, addressing a complex and error-prone area in pharmacovigilance. * **Focus on Continuous and Incremental Innovation:** The company emphasizes "reimagining" existing processes and delivering incremental improvements (e.g., agile study design, quick view, autosave in clinical data management, continuous publishing) to enhance efficiency, user experience, and adaptability to evolving industry needs like frequent protocol amendments. * **Modernizing Regulatory and Content Management:** Innovations like "Vault Publishing" with continuous publishing capabilities for eCTD formats and tight integration with Microsoft Word for collaborative authoring demonstrate a strong commitment to streamlining regulatory submission processes and improving content management within a compliant framework. * **Importance of Integration and Ecosystem:** Veeva's "Spark" integration technology is critical for connecting various Vault applications and external systems, facilitating seamless data flow and business processes across the entire R&D lifecycle, and enabling a more unified operational environment. * **Business Process Transformation is Key:** The speaker explicitly highlights that adopting new technologies, particularly transformative ones like continuous publishing, necessitates significant changes in business processes and roles, underscoring that technology implementation is not merely a tool adoption but a fundamental shift in operations.
IDMP 2019 WHO
IOMPOfficial
/@IOMPOfficial
Aug 31, 2019
This video, presented by Adriana Velásquez and María del Rosario Pérez, serves as an invitation to celebrate the International Day of Medical Physics, organized by the International Organization of Medical Physics (IOMP). The core purpose of the address is to draw global attention to the indispensable role of medical physicists in ensuring the safety and quality of radiation interventions within healthcare. The speakers underscore the rapid advancements in radiation health technologies and the consequent imperative to elevate the education, training, availability, and recognition of medical physicists worldwide. The presentation delves into the diverse applications of radiation health technologies, encompassing diagnostic radiology, nuclear medicine, interventional radiology, and radiotherapy. It highlights their critical utility in the diagnosis and treatment of various diseases, specifically mentioning cancer care and the management of cardiovascular diseases. A central theme is the necessity for robust support systems to guarantee that these advanced technologies are not only produced correctly but also properly calibrated, absorbed into clinical practice, and effectively maintained for optimal performance. The speakers emphasize that despite the increasing availability of radiation technology and equipment in many settings, the presence of qualified medical physicists is crucial for maintaining patient care quality and mitigating health risks. Furthermore, the video stresses the vital function of medical physicists in providing radiation protection education and training for healthcare professionals. They are portrayed as key figures in implementing and upholding radiation safety standards within clinical environments. The overall message is a call to action for global recognition and support for the medical physics profession, ensuring that as radiation technologies continue to evolve and expand, patient safety and the quality of care remain paramount through the expertise and dedication of these specialists. The address concludes with a congratulatory note to medical physicists globally for their contributions, reinforcing the significance of their work. Key Takeaways: * **Critical Role of Medical Physicists:** Medical physicists are fundamental to guaranteeing the safety and quality of radiation interventions, acting as guardians of patient well-being in an increasingly technology-driven healthcare landscape. * **Scope of Radiation Health Technologies:** The field encompasses a broad spectrum of applications, including diagnostic radiology, nuclear medicine, interventional radiology, and radiotherapy, all vital for modern diagnosis and treatment. * **Addressing Major Diseases:** These technologies are crucial for managing severe conditions like cancer and cardiovascular diseases, underscoring their impact on public health. * **Global Imperative for Professional Advancement:** Rapid technological advancements necessitate a global focus on improving the education, training, availability, and recognition of medical physicists to keep pace with innovation. * **Ensuring Technology Efficacy and Safety:** Adequate support is required to ensure that radiation technologies are produced correctly, calibrated accurately, properly integrated into clinical practice, and maintained for effective and safe performance. * **Optimal Device Utilization:** Medical physicists play a key role in ensuring that radiation-emitting devices are used optimally, maximizing therapeutic benefits while minimizing risks. * **Radiation Protection Education:** They are essential educators, providing critical radiation protection training to other healthcare professionals, which is vital for a safe clinical environment. * **Implementation of Safety Standards:** Medical physicists are responsible for implementing and upholding rigorous radiation safety standards in clinical settings, ensuring compliance and best practices. * **Quality Assurance in Patient Care:** Their expertise directly contributes to the quality of patient care by minimizing health risks associated with radiation exposure and ensuring the accuracy of diagnostic and therapeutic procedures. * **Addressing Gaps in Availability:** There's a recognized need to ensure that qualified medical physicists are available in all settings where radiation technology is introduced, preventing potential safety and quality compromises. Key Concepts: * **Medical Physics:** A branch of applied physics concerned with the application of physics concepts, theories, and methods to medicine or healthcare. It involves the use of radiation and other physical principles for diagnostic and therapeutic purposes. * **Radiation Health Technologies:** A collective term for medical technologies that utilize various forms of radiation for medical purposes. This includes: * **Diagnostic Radiology:** Using X-rays, CT scans, and MRI for imaging internal body structures. * **Nuclear Medicine:** Using small amounts of radioactive materials (radiopharmaceuticals) to diagnose and treat a variety of diseases. * **Interventional Radiology:** Performing minimally invasive procedures using image guidance (e.g., X-ray, ultrasound, CT, MRI). * **Radiotherapy:** Using high-energy radiation to treat cancer by damaging cancer cells. * **Radiation Safety Standards:** Guidelines and regulations designed to protect patients, healthcare workers, and the public from unnecessary exposure to radiation, ensuring that radiation use is justified and optimized. * **Calibration:** The process of configuring an instrument to provide a result for a sample within an acceptable range, ensuring accuracy and reliability of radiation doses or measurements. * **Quality Assurance:** A systematic process of checking to see whether a product or service being developed is meeting specified requirements, crucial for the safe and effective operation of medical devices. Examples/Case Studies: * The video highlights the application of radiation technologies in **cancer care**, where radiotherapy is a primary treatment modality. * It also mentions the use of these technologies in the **management of cardiovascular diseases**, indicating their broader diagnostic and therapeutic utility beyond oncology.
Blockchain in Action: How IQVIA Built an App Streamlining Drug Labels
Salesforce Developers
/@SalesforceDevs
Jun 26, 2019
This video explores a real-world application of blockchain technology by IQVIA, a leading life sciences company, to streamline the complex and highly regulated process of managing prescription drug labels using Salesforce Blockchain. The speakers highlight how traditional methods for label changes are inefficient, involve numerous parties, and lack consistent version control, posing significant challenges for regulatory compliance and patient safety. Blockchain is presented as a transformative solution to these issues, offering an immutable ledger, distributed network, and consensus workflows to ensure the permanence, provenance, and real-time replication of critical label information across stakeholders, including pharmaceutical companies, regulatory bodies, and design teams. Key Takeaways: * **Blockchain for Regulated Content Management:** The video demonstrates a powerful application of blockchain in the pharmaceutical industry for managing highly sensitive and regulated content like drug labels, ensuring immutable evidence, auditability, and real-time consistency across a multi-party ecosystem. * **Addressing Operational Inefficiencies in Life Sciences:** Blockchain is positioned as a solution to overcome the inherent complexities and inefficiencies of traditional drug label management, which is characterized by disparate data sources, manual processes, and challenges in maintaining version control and audit trails. * **Architectural Paradigm Shift:** The speakers advocate for viewing blockchain as a new architectural layer for enterprise systems, specifically for recording immutable events and facilitating "collaborative coding" of smart contracts among different organizations, moving beyond its common association with supply chain or cryptocurrency. * **Enhanced Regulatory Compliance and Patient Safety:** By providing a trusted, shared record of all label changes and their history, the solution significantly enhances regulatory compliance (e.g., FDA, EMA, GxP) and enables rapid, secure updates to critical drug information, directly impacting patient safety. * **Salesforce's Role in Enterprise Blockchain:** The successful prototyping of this solution on Salesforce Blockchain underscores Salesforce's capability to provide a declarative, integrated platform for enterprise-grade blockchain applications, particularly within regulated industries. * **Data Provenance and Auditability:** The "blockchain Timeline view" feature, which tracks every change and its history, offers robust data provenance and audit trail capabilities, crucial for meeting stringent regulatory requirements.
Regulatory Intelligence Trailer
Kathy Barnett
/@kathybarnett4070
Jun 5, 2019
This video provides an in-depth exploration of Regulatory Intelligence (RI), defining its core components, differentiating it from mere regulatory information, and outlining its critical role in shaping successful strategies for pharmaceutical and medical device companies. The presentation begins by establishing the necessity of RI in a constantly evolving regulatory landscape, setting the stage for understanding its importance beyond simply tracking regulations. It aims to equip attendees with the knowledge to identify sources, evaluate research questions, utilize RI databases, and effectively summarize and present findings to their teams. The speaker meticulously defines regulatory information as the act of gathering and analyzing publicly available regulatory data, including communicating its implications and monitoring the environment for opportunities to influence future regulations, guidance, and policy. A key distinction is drawn between this raw "regulatory information" and "regulatory intelligence." While information is the data dump—the written, published, or unpublished raw material—intelligence is the active capacity to acquire knowledge through analysis and surveillance. For instance, gathering data on competitor products (trade names, routes of administration, labeling, clinical trials, drug class, submission/approval dates) constitutes regulatory information. In contrast, regulatory intelligence involves taking this information, summarizing it into an executive report, and analyzing it to review competitor products, the current regulatory landscape, and submission routes to inform a company's strategic direction. The presentation further distills regulatory intelligence into three major guiding principles: gathering data, analyzing information, and formulating regulatory strategy. It emphasizes that RI is often one of the most misinterpreted roles within regulatory departments, particularly in consulting capacities for pharmaceutical and device companies. Far from being a passive data collection exercise, RI is presented as the "creative part of regulatory affairs," crucial for informed decision-making. The speaker clarifies what RI is not, distinguishing it from competitive intelligence (typically a marketing function), proprietary sales or marketing information, drug pricing, or reimbursement issues. Instead, RI leverages regulatory information, potentially alongside other data, to provide a comprehensive analysis that enables a company to move forward in an informed and strategic manner. Key Takeaways: * **Defining Regulatory Intelligence (RI):** RI is the systematic act of gathering, analyzing, and communicating publicly available regulatory information, monitoring the environment, and assessing implications to shape future regulations, guidance, policy, and legislation. It is crucial for developing successful regulatory strategies in a dynamic landscape. * **Information vs. Intelligence:** Regulatory information refers to the raw, published or unpublished data (e.g., competitor product details like trade names, clinical trials, approval dates). Regulatory intelligence, conversely, is the active capacity to acquire knowledge and experience through analysis and surveillance, transforming raw data into strategic insights. * **Three Pillars of RI:** Effective regulatory intelligence is built upon three fundamental components: gathering data, analyzing information, and developing a clear regulatory strategy based on these insights. These pillars guide the entire RI process. * **Strategic Value of RI:** RI is not merely compliance tracking; it is a strategic function that helps companies understand the current regulatory landscape, anticipate changes, and make informed decisions to advance their products and operations. It enables proactive rather than reactive engagement with regulations. * **Scope of RI:** The process of RI encompasses identifying diverse information sources, continuously monitoring the regulatory landscape, effectively using regulatory intelligence databases for research, and then summarizing, analyzing, integrating, and presenting the intelligence to relevant teams. * **RI as a Creative Role:** The speaker highlights RI as the "creative part of regulatory affairs," often underestimated or misinterpreted. It requires critical thinking and analytical skills to synthesize information into actionable strategies, rather than just reporting facts. * **What RI Is Not:** It's important to distinguish RI from competitive intelligence (which focuses on market and competitor strategies), proprietary sales or marketing data, drug pricing, or insurance/reimbursement information. RI specifically focuses on the regulatory implications and landscape. * **Example of RI Application:** A practical application involves gathering comprehensive information on competitor products (e.g., submission dates, labeling, clinical trials) and then generating a regulatory intelligence report with an executive summary that analyzes this data to inform a company's development and submission routes. * **Importance of Ongoing Monitoring:** Due to the "constantly changing regulatory environment," continuous monitoring and evaluation of the landscape are essential components of effective regulatory intelligence. This ensures strategies remain current and compliant. * **Structured Research Approach:** Conducting RI involves breaking down a regulatory research question into "researchable units" and then systematically using available databases and sources to gather the necessary information. Key Concepts: * **Regulatory Intelligence (RI):** The process of gathering, analyzing, and applying regulatory information to inform strategic decisions and shape future regulatory environments. * **Regulatory Information:** Raw, publicly available data, documents, and guidelines from regulatory bodies. * **Regulatory Landscape:** The current and evolving set of laws, regulations, directives, guidance documents, and policies governing an industry. * **Regulatory Strategy:** A plan developed based on regulatory intelligence to navigate the regulatory environment, achieve approvals, and maintain compliance. * **Executive Summary:** A concise overview of a regulatory intelligence report, highlighting key findings and strategic implications for decision-makers. Examples/Case Studies: * **Competitor Product Analysis:** The video uses the example of analyzing competitor products to illustrate the difference between information and intelligence. Gathering details like trade names, routes of administration, labeling, pivotal clinical trials, drug class, and submission/approval dates in various countries is regulatory information. Transforming this into an "executive summary" that reviews competitor products, the current regulatory landscape, and submission routes to guide a company's direction is regulatory intelligence.
Vertex Reduces EDC Study Build Times by 50%
Veeva Systems Inc
/@VeevaSystems
May 16, 2019
This video provides an in-depth exploration of how Vertex Pharmaceuticals significantly reduced its EDC (Electronic Data Capture) study build times and accelerated clinical data lock processes, achieving a 50% reduction in study build times. Featuring insights from Vertex's senior and associate directors of clinical data management and metrics, Vitas Galati and Michelle Garrison, alongside Richard Young from Veeva Systems, the discussion highlights Vertex's journey in optimizing clinical operations. The webinar contrasts Vertex's industry-leading performance against broader industry benchmarks, particularly referencing "Tufts data" on average timelines for data entry, query resolution, and database lock. The core of Vertex's success lies in a multi-faceted approach centered on a "sites first, patients first" philosophy. This ethos drives their operational strategies, emphasizing consistency in database creation, standardized query application, and continuous, open communication with clinical sites. Vertex actively engages sites through regular meetings, data management-specific tables at investigator meetings for live demos and feedback, and weekly newsletters for updates and training. This collaborative approach, coupled with a focus on understanding site motivations rather than imposing penalties, has led to exceptional site performance, with data entry often within 48 hours and query responses within 72 hours, significantly outperforming industry averages. A key conceptual shift discussed is the move from "database lock" to "data lock," recognizing that 70-80% of critical study data often originates from external sources outside the EDC system. Vertex prioritizes the reconciliation and locking of all relevant data, including external data, aiming for a complete, quality-assured data lock within 15 days from the last subject's last visit. This aggressive timeline is supported by proactive data review starting from the first patient screen, ensuring live data access for clinical and medical monitoring teams, and automating lab data downloads within 24 hours. The "onion slide" concept illustrates Vertex's layered, risk-based approach to data review, acknowledging that multiple checks occur at various stages, allowing for more focused attention on critical data points. The entire process requires strong organizational buy-in across clinical, medical, and vendor teams, with a culture of continuous innovation and improvement. Key Takeaways: * **Industry-Leading Performance:** Vertex achieved a 50% reduction in EDC study build times and consistently locks clinical data within 15 days, significantly faster than the industry average of 40 days. They also boast rapid data entry (within 48 hours) and query response (within 72 hours) from sites. * **Site-Centric Philosophy:** A "sites first, patients first" approach is paramount. Vertex fosters collaboration and understanding with sites, using a "carrot, not stick" method, avoiding penalty clauses, and focusing on consistent processes and clear communication to motivate high-quality data submission. * **Proactive Data Management:** Data review begins immediately from the first patient screen, not waiting for milestones. This ensures continuous monitoring and early identification of issues, allowing clinical and medical monitoring teams live access to data for real-time patient oversight. * **Emphasis on External Data:** Recognizing that 70-80% of primary and secondary endpoint data often comes from external sources (e.g., labs), Vertex redefines "database lock" to "data lock," focusing on comprehensive reconciliation and locking of all critical data, internal and external. * **Automated Data Acquisition:** Significant effort is invested in automating data downloads from primary labs, aiming to receive lab data within 24 hours of collection or report generation, drastically reducing data transfer times. * **Risk-Based Data Review:** The "onion slide" concept illustrates that data undergoes multiple layers of review (e.g., CCGs, error checks, CDM, cross-functional teams). This allows for a risk-based approach, dedicating more intensive review to critical data points while trusting the multi-layered system for general data quality. * **Organizational Buy-in is Crucial:** Achieving rapid data lock requires a coordinated effort and buy-in from the entire organization, including clinical, medical, and vendor teams, ensuring everyone is aligned with the quality and timeline goals. * **Strategic Vendor Management:** Vertex engages vendors early in the contracting process to establish expectations for timely and quality data transfers. They also explore consolidating vendors or routing specialty lab data through central labs to streamline data flow and reduce the number of interfaces. * **Continuous Improvement and Standardization:** Lessons learned from every study are applied to subsequent trials. Vertex emphasizes training, standardizing data transfer specifications, and reusing data collection standards to achieve greater efficiency and consistency. * **Innovation as a Cultural Imperative:** Vertex maintains a culture of innovation, constantly challenging internal processes and seeking better, faster ways to operate while maintaining quality, which was a key driver in their partnership with Veeva. **Tools/Resources Mentioned:** * **Veeva Systems:** The platform and software used by Vertex for their clinical data management, specifically EDC. * **Tufts Data:** Research on industry benchmarks for clinical trial timelines (data entry, query resolution, database lock). **Key Concepts:** * **EDC Study Build Times:** The time required to set up and configure an Electronic Data Capture system for a new clinical study. * **Data Lock / Database Lock:** The process of finalizing and freezing a clinical trial database or all relevant study data (including external sources) to prevent further changes before analysis and submission. Vertex advocates for "data lock" to encompass all critical data, not just what's in the EDC. * **Clinical Data Management (CDM):** The process of collecting, cleaning, and managing data from clinical trials to ensure its accuracy, completeness, and validity. * **Site-Centric Approach:** A philosophy in clinical trials that prioritizes the needs and experiences of the clinical research sites and their staff to foster better collaboration and data quality. * **Risk-Based Data Review:** A strategy for reviewing clinical trial data where resources and effort are concentrated on data points and processes deemed most critical to patient safety and study integrity, rather than uniformly reviewing all data. **Examples/Case Studies:** * **Vertex Pharmaceuticals:** The entire discussion serves as a case study of Vertex's successful implementation of advanced clinical data management strategies, showcasing their specific achievements in reducing study build times and accelerating data lock processes in their cystic fibrosis (CF) trials.
28b Veeva Insights - Episode 3: Functional content for better sales outcomes
twentyeightb
/@twentyeightb
May 13, 2019
This video provides an in-depth exploration of leveraging functional content within Veeva CLM (Content Lifecycle Management) for enhanced sales outcomes in the pharmaceutical industry. The speaker, James Harper, founder of twentyeightb, aims to help brand teams and medical communications agencies better understand and utilize the Veeva CRM platform. The episode focuses specifically on "functional interactive content" for Veeva CLM multi-channel presentations, often referred to as eDetailers, eSales Aids, or digital sales aids. The core of the discussion revolves around defining and demonstrating the power of "functional content" compared to static or basic interactive content. Functional content is described as content that "works for a living," actively engaging both the user (Key Account Manager) and the customer (healthcare professional). It calculates, measures, records, and personalizes information to maximize impact, going beyond simple navigation or pop-ups. This advanced content not only drives greater customer engagement but also provides valuable market insights, monitors content effectiveness, and significantly enhances sales effectiveness. A practical example is demonstrated using a hypothetical product that has secured a new pediatric indication. The critical success factor for this brand is to increase the recognition and treatment of children with this condition. The functional content enables a Key Account Manager (KAM) to initiate a sales call by asking a General Practitioner (GP) to prioritize various patient types (e.g., elderly, pregnant mothers, pediatrics) they see with the condition. This interactive prioritization, where the GP can drag and drop patient groups into an order reflecting their current practice, allows the KAM to understand the GP's perspective on treating children. This data is then saved against the customer's record within the Veeva CRM. This saved, personalized data is crucial as it can dynamically drive the rest of the presentation, ensuring the content is tailored to the GP's specific priorities. The same personalized priority order can reappear at the end of the presentation, enabling the KAM to close with a targeted commitment from the doctor, such as reprioritizing pediatric treatment based on the evidence presented. Furthermore, this data powers subsequent calls, allowing the rep to pick up exactly where they left off, reinforcing the discussion and moving the customer along the adoption ladder. The brand team can then run reports on this aggregated CRM data to gain critical market and customer insights, informing and enhancing future marketing strategies. Key Takeaways: * **Functional Content Definition:** Functional content goes beyond static "digital paper" or basic interactive elements. It actively calculates, measures, records, and personalizes content, making it "work for a living" to achieve specific sales and marketing objectives. * **Enhanced Sales Effectiveness:** Implementing functional content significantly improves customer engagement, provides actionable market insights, monitors content impact, and ultimately leads to better sales outcomes by tailoring interactions to individual customer needs. * **Veeva CLM as a Platform:** Veeva CLM multi-channel presentations (eDetailers, eSales Aids) are ideal vehicles for deploying functional content, allowing for dynamic and data-driven sales interactions within a regulated environment. * **Empowering Key Account Managers (KAMs):** Functional content equips KAMs to effectively set up sales calls, deeply understand customer needs through interactive engagement, facilitate strong closes with personalized commitments, and seamlessly set up follow-up discussions. * **Data Capture and CRM Integration:** A critical aspect is the ability of functional content to capture customer-specific data (e.g., patient prioritization, treatment percentages) and save it directly against the customer's record within the Veeva CRM. * **Personalized Content Delivery:** The data collected through functional content can dynamically drive and personalize subsequent parts of the presentation, ensuring that the information presented is most relevant and impactful for the individual healthcare professional. * **Driving Future Interactions:** Stored customer data can be used to power content for subsequent sales calls, allowing reps to resume conversations from where they left off, track progress, and reinforce commitments, effectively guiding customers along the adoption ladder. * **Valuable Market and Customer Insights:** The aggregated data from functional content across the sales force provides brand teams with critical market and customer insights, which are invaluable for refining marketing plans, identifying trends, and optimizing strategies. * **Strategic Closing Techniques:** Functional content enables KAMs to craft highly personalized closing statements based on the customer's input during the presentation, leading to more concrete commitments and measurable outcomes. * **Multifunctional Design:** A single piece of well-designed functional content can serve multiple purposes within a sales call, from initial needs assessment to closing and even setting the stage for future engagements. **Tools/Resources Mentioned:** * Veeva CRM * Veeva CLM (Multichannel Presentations, eDetailers, eSales Aids, Digital Sales Aids) **Key Concepts:** * **Functional Content:** Content designed to actively engage users and customers by calculating, measuring, recording, and personalizing information for maximum impact and specific outcomes. * **Veeva CLM:** Content Lifecycle Management, a module within Veeva CRM, used for creating, managing, and delivering interactive sales presentations and eDetailers to healthcare professionals. * **Critical Success Factor (CSF):** A key objective or goal for a brand or campaign, often used to measure success (e.g., increasing recognition of a new drug indication). * **Adoption Ladder:** A conceptual model illustrating the stages a customer progresses through from initial awareness to full adoption and advocacy of a product or behavior.
28b Veeva Insights - Episode 1: Veeva CRM Approved Email
twentyeightb
/@twentyeightb
May 13, 2019
This video provides an in-depth exploration of Veeva CRM Approved Email (VAE), a critical tool within the Veeva CRM platform designed to empower pharmaceutical brand teams and field specialists. The presenter, James Harper, founder of twentyeightb, introduces VAE as an essential component for leveraging multi-channel marketing efforts and enhancing customer engagement. The primary objective of the episode is to guide users through the functionalities of VAE, particularly focusing on its use within the CRM for iPad application (formerly iRep), to send compliant, approved, and personalized content to healthcare professionals and contacts. The discussion highlights VAE's integral role within the broader Veeva ecosystem, emphasizing its seamless integration with other CRM and CLM tools such as Veeva Engage and Veeva Vault documents. A key advantage presented is the robust analytics capability, where VAE usage data, including send and open rates, feeds directly back into the CRM system. These analytics are crucial for motivating field teams, increasing platform adoption, measuring and enhancing sales effectiveness, and providing valuable market insights back to brand or medical teams. The video details various practical applications for VAE, such as following up on calls, sharing educational materials, distributing budget impact models, and inviting customers to webinars or remote detail sessions. The core of the episode walks viewers through the classic VAE user interface on the CRM for iPad. This includes selecting a target customer, accessing the "send email" action, and navigating the highly granular control system that ensures only appropriate and approved content is available for specific customers. The process involves selecting an email template, which forms the base structure with greetings, disclaimers, and corporate branding. Users then have the ability to personalize the email by adding "fragments"—small, approved content elements. The video demonstrates how personalization can be managed through drop-down lists and free-text fields, with built-in controls like blacklisting words and mandating field completion to maintain compliance. A notable feature is the automated referencing system, which intelligently renumbers references even when fragments are reordered, ensuring accuracy. The episode concludes with a demonstration of previewing the email and the "slide-to-send" mechanism, a thoughtful design choice to prevent accidental dispatches. Key Takeaways: * **Compliant Personalized Communication:** Veeva Approved Email (VAE) enables pharmaceutical field teams to send highly personalized email content to customers and contacts while strictly adhering to regulatory and brand compliance standards. * **Integrated Veeva Ecosystem:** VAE is an integral part of the Veeva platform, seamlessly integrating with other critical tools like Veeva CRM, CLM (Content Lifecycle Management), Veeva Engage, and Veeva Vault documents, ensuring a unified multi-channel marketing approach. * **Actionable Analytics for Performance:** Usage analytics, including send and open rates, are automatically fed back into the CRM system, providing detailed insights that can be used to motivate field teams, increase platform usage, enhance sales and customer engagement effectiveness, and generate market insights for brand and medical teams. * **Diverse Use Cases:** VAE supports a wide range of commercial operations, including post-call follow-ups, sharing educational materials, distributing budget impact models, and sending invitations to educational meetings, webinars, or remote detailing sessions. * **Granular Content Control:** The platform offers a highly granular level of control over email templates and content fragments, ensuring that only content appropriate and approved for specific users and target customers is available for distribution. * **Robust Personalization Features:** Users can personalize emails through various mechanisms, including drop-down lists and free-text fields, with built-in compliance features such as blacklisting specific words or terms and mandating field completion before an email can be sent. * **Automated Referencing System:** A clever feature of VAE is its automated referencing system, which automatically renumbers references within an email even when content fragments are reordered, maintaining accuracy and compliance without manual intervention. * **Intuitive User Interface:** The video demonstrates a straightforward user interface within the CRM for iPad app, guiding users through selecting customers, choosing templates, adding and reordering content fragments, and previewing the final email. * **"Slide-to-Send" Mechanism:** To prevent accidental email dispatches, VAE incorporates a "slide-to-send" icon, requiring a deliberate user action to confirm sending, enhancing user control and reducing errors. * **Strategic Multi-channel Enabler:** VAE is positioned as an essential tool for field specialists to link up and fully utilize the suite of multi-channel marketing tools and materials available to them, bridging the gap between in-person interactions and digital engagement. * **Future Enhancements:** The series promises to cover advanced functionalities in subsequent episodes, such as launching VAE directly from within a detail aid and leveraging Veeva CRM MyInsights dashboards to inform and enhance a user's effectiveness in the field. Tools/Resources Mentioned: * Veeva CRM * Veeva Approved Email (VAE) * CRM for iPad (previously known as iRep) * Veeva CLM (Content Lifecycle Management) * Veeva Engage * Veeva Vault documents * Veeva CRM MyInsights (mentioned as a topic for future episodes) Key Concepts: * **Veeva Approved Email (VAE):** A core module within Veeva CRM designed to enable pharmaceutical field teams to send pre-approved, compliant, and personalized email communications to healthcare professionals and other contacts. It ensures all outbound email content adheres to regulatory guidelines and brand messaging. * **Email Template:** The foundational structure of an email within VAE, which typically includes standard greetings, corporate logos, disclaimers, and sign-offs. These templates provide a consistent and compliant framework for all communications. * **Fragments:** Modular, pre-approved content blocks that users can select and insert into an email template. Fragments allow for dynamic personalization and ensure that even customized emails remain compliant with pre-defined messaging and regulatory requirements. * **Automated Referencing System:** A sophisticated feature of VAE that automatically manages and renumbers references within an email as fragments are added, removed, or reordered. This ensures that all scientific and medical claims are accurately sourced and compliant, even with dynamic content changes. * **Multi-channel Marketing:** A strategic approach that integrates various communication channels (e.g., email, in-person visits, webinars, digital content) to engage customers effectively. VAE is presented as a key tool for connecting these channels within the pharmaceutical commercial strategy.
28b Veeva Insights - Episode 2: Advanced Veeva CRM Approved Email
twentyeightb
/@twentyeightb
May 13, 2019
This video provides an in-depth exploration of advanced implementations of Veeva CRM Approved Email (VAAIE) and the strategic utilization of MyInsights dashboards to enhance the effectiveness of Key Account Managers (KAMs) in the field. James Harper, Founder and Managing Director of 28b, guides brand teams and creative agencies through leveraging these Veeva CRM tools, focusing on practical applications for optimizing commercial operations. The episode builds upon foundational knowledge of VAAIE, delving into more sophisticated integrations and data visualization techniques. The presentation begins by demonstrating how KAMs can seamlessly launch Approved Emails directly from within an eDetail. This streamlined process is exemplified by a scenario where a new product guideline necessitates informing customers and inviting them to local medical education meetings. The video illustrates how a KAM can engage a customer with the meeting idea, navigate to a dedicated "meetings tab" within the eDetail, select a suitable time and location, and then, with a single tap, launch a pre-populated VAAIE template. This integration significantly reduces the time and effort required to send targeted communications, allowing KAMs to quickly return to their eDetail and continue their sales conversation. Following the demonstration of efficient email delivery, the video transitions to the critical role of Veeva CRM MyInsights in maximizing the return on investment (ROI) for these medical education meetings. MyInsights is presented as an innovative data visualization capability designed to deliver relevant information precisely when and where field teams need it. The speaker showcases a custom-built MyInsights dashboard accessible at the territory level, providing KAMs with a quick overview of recruitment progress across multiple meetings. This dashboard integrates standard VAAIE analytics—such as email sent, opened, and link clicked—with data from Veeva CRM Events Management to track actual event registrations. By visually representing recruitment status and identifying specific customers to follow up with, MyInsights empowers KAMs with actionable intelligence to ensure maximum attendance and optimal ROI for their initiatives. Key Takeaways: * **Integrated Approved Email Launch:** Veeva CRM Approved Email (VAAIE) can be launched directly from within an eDetail, significantly streamlining the communication process for Key Account Managers (KAMs) and enabling them to send targeted emails in seconds. * **Enhanced Field Efficiency:** This direct launch capability allows KAMs to quickly send critical information, such as invitations to medical education meetings, without leaving their eDetail, thus minimizing disruption and maximizing time spent on selling. * **Automated Template Population:** The system can automatically select the correct VAAIE template and populate it with relevant fragments (e.g., meeting details), reducing manual effort and ensuring consistency and compliance. * **Strategic Use of Veeva CRM MyInsights:** MyInsights is a powerful data visualization tool within Veeva CRM that provides field teams with timely and relevant information, accessible at both customer and territory levels. * **Optimizing Medical Education Meetings:** Custom MyInsights dashboards can be designed to specifically track and optimize the recruitment for local medical education meetings, providing KAMs with a clear overview of their progress. * **Actionable Recruitment Insights:** These dashboards combine standard VAAIE analytics (email sent, opened, clicked) with Veeva CRM Events Management data (event registration) to give KAMs a comprehensive view of customer engagement and attendance. * **Data-Driven Follow-up:** MyInsights empowers KAMs with actionable information, visually indicating recruitment performance and identifying specific customers who should be invited next or require follow-up, ensuring maximum attendance and ROI. * **Focus on Sales Effectiveness:** The ultimate goal of these advanced Veeva CRM implementations is to enhance infield sales effectiveness and contribute to positive sales outcomes by providing field teams with the tools and insights they need. * **Future Content Integration:** The video hints at future episodes that will explore functional eDetail content, market insights, KPI tracking, and monitoring content usage, all aimed at further improving sales effectiveness. Tools/Resources Mentioned: * Veeva CRM * Veeva CRM Approved Email (VAAIE) * Veeva CRM MyInsights * Veeva CRM Events Management Key Concepts: * **eDetail:** Electronic detailing, an interactive presentation used by sales representatives on tablets or other devices to engage healthcare professionals. * **Key Account Manager (KAM):** A sales role focused on managing and developing relationships with strategically important customers or accounts. * **Approved Email:** A compliant email communication system within Veeva CRM that ensures all content is pre-approved by regulatory and medical teams before being sent to healthcare professionals. * **MyInsights:** A data visualization and dashboarding capability within Veeva CRM that allows for custom reports and actionable insights to be delivered directly to field teams. * **Medical Education Meetings:** Events organized by pharmaceutical companies to educate healthcare professionals on new products, guidelines, or therapeutic areas. * **ROI (Return on Investment):** A performance measure used to evaluate the efficiency of an investment or to compare the efficiency of several different investments. In this context, it refers to the effectiveness of medical education meetings in terms of customer engagement and attendance.
eTMF Working Paperless
ECCRT
/@eccrt1731
Apr 5, 2019
This video explores the critical transition to eTMF (electronic Trial Master File) and paperless operations within clinical research, focusing on regulatory requirements and practical implementation. The speaker, Dr. Marleen Van Bael, details the advantages of digital documentation, outlines the latest guidelines from the European Medicines Agency (EMA) and Good Clinical Practice (GCP), and provides insights into ensuring compliance when working with electronic trial documents. The discussion covers the necessity of validated computerized systems, the process of converting paper to digital, and the evolving landscape of electronic source data. Key Takeaways: * **Regulatory Mandate for Digital:** EMA and GCP guidelines require robust electronic systems for trial documentation, treating electronic and paper formats with equal stringency, emphasizing the industry's shift towards digital. * **Multifaceted Benefits of Paperless:** Beyond mere efficiency, electronic systems offer enhanced data quality, immediate access to up-to-date information, improved traceability, support for risk-based monitoring and remote work, and greater protection against physical data loss. * **Validation is Non-Negotiable:** Computerized systems for eTMF and electronic source data must be thoroughly validated to guarantee data integrity, security, comprehensive audit trails (tracking all actions), and protection against any unauthorized alterations, adhering strictly to GxP principles. * **Certified Copies and Secure Destruction:** An electronic "certified copy" requires a validated system that ensures it's an exact replica of the original. Paper originals can only be destroyed if the electronic version is created via a validated process with stringent quality control during scanning, ensuring no data is lost or altered. * **Operational Preparedness is Key:** Successful adoption of paperless systems necessitates clear Standard Operating Procedures (SOPs), consistent file naming conventions, role-based access controls, and mandatory training for all personnel involved in managing electronic documentation. * **Rise of Electronic Source Data:** The industry is increasingly moving towards direct electronic source data capture (eSource), with EMA providing guidance on expectations for such systems, highlighting the need for robust integration and control mechanisms, often involving hospital-owned data.
Veeva CEO: Revolution in Medicine | Mad Money | CNBC
CNBC Television
/@CNBCtelevision
Mar 12, 2019
This video features an interview with Peter Gassner, CEO of Veeva Systems, on CNBC's Mad Money, where he discusses the company's significant growth and its pivotal role in the ongoing revolution in medicine. The conversation highlights Veeva's cloud-based software solutions for the life sciences industry, emphasizing how these tools enhance efficiency, ensure regulatory compliance, and support pharmaceutical companies in bringing new drugs to market. Gassner explains Veeva's journey from a niche player to a dominant force, particularly with the success of its Veeva Vault platform, and outlines the company's future trajectory amidst the emergence of precision medicine and the increasing integration of artificial intelligence in healthcare. The discussion delves into Veeva's value proposition, asserting that their cloud software not only saves individual customers money but also significantly increases the overall efficiency of the $1.7 trillion pharmaceutical business. Gassner elaborates on how Veeva's integrated platform addresses various needs, from capturing clinical trial data and managing government regulations to optimizing sales force effectiveness. He underscores the importance of a unified, cloud-based system for life sciences companies, which has driven the rapid adoption and expansion of Veeva's offerings, leading to the company surpassing its revenue targets and projecting a total addressable market exceeding $9 billion. A significant theme explored is the "revolution in medicine," characterized by the shift towards precision medicine, cell therapy, and gene therapy. Gassner positions Veeva as a crucial enabler of this transformation, stating that their technology is "the brains behind a lot of that stuff" when Jim Cramer brings up artificial intelligence in healthcare. The interview touches upon the increasing valuation of innovative biotech companies, citing the acquisition of Spark Therapeutics by Roche as an example of the premium placed on cutting-edge science in areas like gene therapy for hereditary conditions. Veeva's collaboration with both large pharmaceutical companies and smaller, innovative biotechs like Spark Therapeutics and Bluebird Bio further solidifies its role at the forefront of this medical paradigm shift. Key Takeaways: * **Veeva's Dominance in Life Sciences Cloud:** Veeva Systems has established itself as a leading provider of cloud-based software for the life sciences industry, offering a comprehensive platform that supports pharmaceutical companies from clinical trials to commercial operations and regulatory compliance. * **Efficiency and Cost Savings:** Veeva's solutions are presented as critical for increasing efficiency across the $1.7 trillion pharmaceutical sector, not only by saving individual customers money but also by streamlining complex processes involved in drug development and delivery. * **Veeva Vault's Success:** The Veeva Vault platform has been a significant growth driver, expanding from 5% to nearly 50% of the company's revenue, demonstrating the industry's demand for integrated, cloud-based applications for various operational needs. * **Addressing Industry Needs:** Veeva's software helps pharmaceutical companies capture clinical trial data, comply with government regulations, and enhance the effectiveness of their sales representatives, covering critical aspects of the drug lifecycle. * **Early Stages of Market Penetration:** Despite reaching over a billion dollars in sales, Veeva's CEO believes the company is still in the "very early days" of the industry cloud for life sciences, with a total addressable market estimated at over $9 billion and continuous product expansion. * **Enabling Precision Medicine:** Veeva is strategically positioned to support the "revolution in medicine" towards precision medicine, cell therapy, and gene therapy, which aim to provide highly targeted treatments for individuals. * **AI as a Core Component:** Veeva plays a significant role in the artificial intelligence component of modern healthcare, with its CEO confirming that Veeva's technology is "the brains behind a lot of that stuff," aligning with the vision of AI making healthcare more human. * **Innovation Drives Acquisitions:** The interview highlights how innovation in areas like precision medicine and gene therapy is driving significant acquisitions in the biotech sector, as larger pharmaceutical companies seek to integrate cutting-edge science. * **Support for Diverse Clients:** Veeva works with a broad spectrum of clients, from large pharmaceutical corporations to smaller, innovative biotechs, facilitating groundbreaking work in new therapeutic areas. * **Strategic Product Development:** The company's strategy involves continuously adding new products to its portfolio, ensuring it remains at the forefront of technological advancements and expanding its market reach within the life sciences ecosystem. Tools/Resources Mentioned: * Veeva Systems (cloud-based software) * Veeva Vault (specific product platform) * Salesforce.com (mentioned in context of Peter Gassner's background and partnership) * "Deep Medicine: How Artificial Intelligence can make Healthcare Human Again" by Dr. Eric Topol (book reference) Key Concepts: * **Cloud-based Software:** Delivery of software as a service over the internet, enabling scalability, accessibility, and efficiency for life sciences operations. * **Life Sciences Industry Cloud:** Specialized cloud platforms tailored to the unique regulatory, data, and operational requirements of pharmaceutical, biotech, and medical device companies. * **Precision Medicine:** An emerging approach to disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person. * **Cell Therapy & Gene Therapy:** Advanced therapeutic approaches that involve introducing new genetic material or cells into a patient's body to treat or prevent disease. * **Artificial Intelligence (AI) in Healthcare:** The application of AI technologies to improve various aspects of healthcare, from drug discovery and clinical trials to diagnostics and patient care. * **Regulatory Compliance:** Adherence to government regulations and industry standards, particularly critical in the highly regulated pharmaceutical and life sciences sectors. Examples/Case Studies: * **Spark Therapeutics Acquisition:** The acquisition of Spark Therapeutics, a biotech company focused on gene therapy for hereditary blindness, by Roche, illustrating the premium placed on innovation in precision medicine. * **Bluebird Bio:** Mentioned as another innovative biotech company working on new therapeutic approaches.
RIMs "By the Numbers" A Quick Look Guide to Inproving Your Global Submissions
MasterControl
/@MasterControlVideo
Nov 16, 2018
This video provides an in-depth exploration of Regulatory Information Management (RIMs) and strategies for improving global submissions in the life sciences and medical device industries. Alex Butler, a Product Marketing Manager at MasterControl with extensive experience in product development and regulatory submissions, highlights the increasing complexity of navigating international markets and evolving regulations. The presentation emphasizes that timely device registration is crucial for market success and delves into common challenges faced by regulatory professionals, offering strategic approaches to overcome them. The core of the discussion identifies prevalent issues that impede efficient global submissions. These include the continued reliance on paper-based systems, disparate processes across different teams or regions, inadequate access and control over critical documents, and poor communication channels. Butler presents startling statistics, noting that 70-90% of 510k and PMA submissions to the FDA are rejected at the first review due to clerical and formatting issues, underscoring a systemic problem of overburdened and understaffed regulatory teams. He describes the current regulatory environment as a "perfect storm" due to significant upcoming changes in regions like Canada and Europe (e.g., EU MDR), which demand immediate strategic adaptation. To address these challenges, the presentation advocates for a holistic, global approach to regulatory success. Key strategies include formalizing procedures and processes across the entire organization, ensuring harmonization of practices with international partners, and establishing a "single source of truth" for all regulatory content. This involves robust metadata management, effective dossier management (treating a body of documents as a single record), and seamless integration with other enterprise solutions like ERP, CRM, and Quality Management Systems (QMS). Butler stresses the importance of project management transparency to accurately track regulatory initiatives, prioritize efforts, and communicate the true cost of delays to executives, who often have unrealistic expectations regarding market clearance timelines. A critical insight shared is the need for early and continuous engagement of regulatory teams throughout the product lifecycle. Regulatory professionals should not be siloed or brought in only at the submission phase; rather, they must participate from the initial concept and research (lab book) stages through design history file development and post-market surveillance. This proactive involvement ensures that content is created with regulatory requirements in mind, reducing downstream rejections and delays. The presentation concludes by urging organizations to educate executives on the complexities and burdens faced by regulatory departments, emphasizing that regulatory success is an enterprise-wide responsibility that requires robust tools, formalized processes, and cross-functional collaboration. Key Takeaways: * **Global Regulatory Complexity:** The regulatory landscape is increasingly complex due to evolving international markets and regulations, making global submissions a daunting but critical task for life sciences companies. Changes in regions like Canada and Europe (e.g., EU MDR) are creating a "perfect storm" that demands proactive strategies. * **Common Submission Pain Points:** Regulatory professionals frequently encounter issues such as paper-based systems, disparate processes across teams, lack of controlled access to documents, and poor communication, all of which contribute to significant delays and rejections. * **High FDA Rejection Rates:** A staggering 70-90% of 510k and PMA submissions to the FDA are rejected at the first review, primarily due to clerical and formatting errors, indicating a fundamental breakdown in submission preparation and quality. * **Underestimated Costs of Delays:** Executive expectations for product clearance timelines (e.g., 90 days for 510k) often do not align with reality. Delays in market clearance lead to substantial financial losses and missed market share opportunities, which are often not adequately captured or reported. * **Regulatory Team Understaffing:** The industry's regulatory teams are generally understaffed, with regulatory staffing often around 1% of the organization, leading to overburdened individuals managing three to five complex projects simultaneously, making errors and slippages almost inevitable. * **Holistic Global Submissions Approach:** Companies need to adopt a global strategy that includes formalized internal procedures, harmonized practices with external partners (affiliates, distributors), and robust document and change control mechanisms across all markets. * **Single Source of Truth:** Establishing a centralized, digital "single source of truth" for all regulatory information is paramount. This includes effective metadata management, dossier management (treating a body of documents as a single record), and secure access controls. * **QMS as a RIMs Foundation:** Organizations should leverage and optimize their existing Quality Management Systems (QMS) to function as a Regulatory Information Management (RIMs) solution, rather than investing in separate, disparate systems. This requires thoughtful configuration and integration. * **Project Management Transparency:** Formalizing project management for regulatory initiatives is crucial. This enables clear communication of project status, bottlenecks, and potential slippages to all stakeholders, including executives, and helps prioritize competing initiatives based on impact and resources. * **Early Regulatory Engagement:** Regulatory teams must be engaged much earlier in the product development lifecycle, ideally from the concept and research (lab book) stages, rather than just at the design history file or submission phase. This proactive involvement helps guide testing, design, and content creation to meet regulatory requirements from the outset. * **Regulatory's Unique Role:** Regulatory professionals have a unique and challenging role, often reporting slippages to executives while not being the authors of 90% of the content required for submissions. This necessitates strong cross-functional communication and collaboration. * **Executive Education is Key:** Executives often lack a full understanding of the burdens and complexities faced by regulatory departments. Educating leadership on regulatory needs, timelines, and the impact of non-compliance is essential for securing necessary resources and support. * **Adaptation to Change:** The constant flux in global regulations requires organizations to continuously monitor changes (e.g., EU MDR, MDSAP) and adapt their processes and strategies to minimize damage and ensure ongoing compliance. **Key Concepts:** * **Regulatory Information Management (RIMs):** Solutions or systems designed to manage and track all regulatory information, submissions, and activities throughout the product lifecycle. * **Dossier Management:** The process of organizing, managing, and controlling access to a collection of related documents (a dossier) that support a regulatory submission or product registration. * **Quality Management System (QMS):** A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives, often used in regulated industries. * **Design History File (DHF):** A compilation of records that describes the design history of a finished medical device, as required by FDA 21 CFR Part 820.30. * **Lab Book:** Refers to the early-stage research and development documentation, often containing proprietary information and initial concepts. * **FDA Refusal to Accept Policy:** An FDA policy outlining the criteria for refusing to accept a submission for review if it is incomplete or contains clerical/formatting errors. * **EU Medical Device Regulation (EU MDR):** A comprehensive regulation governing the production and distribution of medical devices in the European Union, replacing the Medical Device Directive (MDD). * **Medical Device Single Audit Program (MDSAP):** An international program allowing a single audit of a medical device manufacturer's quality management system to satisfy the requirements of multiple regulatory authorities. **Tools/Resources Mentioned:** * **Microsoft Project:** A project management software used for planning, tracking, and managing projects. * **Agile:** A project management methodology that emphasizes iterative development, collaboration, and flexibility. * **MasterControl:** The company hosting the webinar, providing cloud-based quality and compliance software for life sciences and other regulated industries. **Examples/Case Studies:** * **FDA Submission Statistics:** 70-90% of 510k and PMA submissions are rejected at first review due to clerical/formatting issues (from MD UFA quarterly report, Sept 2018). * **Cost of Slippage:** Data from the America Group and LNS reports illustrate the significant financial impact and loss of market share over 10 years for products that are not first or second to market. * **Regulatory Staffing:** Industry data suggests regulatory staffing is often around 1% of an organization, while 25% might be needed for new product development alone, highlighting a severe understaffing issue. * **Customer Examples:** Two customer examples were shared regarding QMS configuration for RIMs: one large company needed less than 20 configuration changes, while a mid-level company needed over 300, emphasizing the importance of a "less is more" approach to metadata.
2018-09-10 TMF Reference Model General Meeting
TMF Reference Model
/@TMFReferenceModel
Nov 14, 2018
This video provides an in-depth exploration of the TMF Reference Model, focusing on community updates, subgroup progress, and the release of version 3.1.0. The general meeting, held in September 2018, served as a platform for various working groups to present their advancements and solicit community involvement, highlighting the collaborative effort behind maintaining and evolving this critical standard for clinical trial documentation. The discussion underscores the model's role in standardizing Trial Master Files (TMFs) across the pharmaceutical and life sciences industries, addressing challenges related to document management, regulatory compliance, and digital information exchange. The meeting progressed through several key updates, beginning with an overview of the TMF Reference Model community's growth, including new project team members, subscribers, and forum participants. Following logistical announcements, the core of the meeting involved detailed reports from specialized subgroups. These included updates on the Non-Interventional Study (NIS) TMF, which is being segmented into three categories for different study types; the Sub-Artifacts team, which is diligently defining sub-artifacts across various TMF zones and seeking additional reviewers; and the Device TMF group, which is reviewing zones to develop a high-level best practices guide and suggesting modifications to artifact names and commentary. A significant portion of the meeting was dedicated to the "Framework for the Destruction of Paper," detailing its project timeline, parameter review, and the development of implementation tools such as decision trees and policy templates, emphasizing the ongoing need for volunteers. A crucial segment of the meeting focused on the Exchange Mechanism Standard (EMS) team, which had recently hosted a business-focused webinar and planned future technical and business webinars to encourage piloting of the EMS by CROs and sponsors. The highlight of the meeting was the announcement of the TMF Reference Model version 3.1.0 release by the Change Control Board (CCB). This "minor update," effective October 10th, incorporated 23 approved change requests out of 64 submitted since 2015. Key changes included the integration of dating conventions and milestones (country, trial, site levels) directly into the model, minor artifact name adjustments, updated definitions, the addition of a few sub-artifacts, correction of typographical errors, and updates to filing levels and alternate names. The meeting concluded with a discussion on the impact of this new version, emphasizing that while changes were minimal and primarily aimed at consistency, the stable artifact ID numbers ensure seamless data exchange and mapping, even with evolving artifact names. Key Takeaways: * **TMF Reference Model as a Core Standard:** The TMF Reference Model is a foundational standard for managing clinical trial documentation, crucial for regulatory compliance and operational efficiency within the pharmaceutical and life sciences sectors. Its continuous evolution reflects industry needs and best practices. * **Community-Driven Development:** The model's development and updates are a collaborative effort, relying on a large community of volunteers, project teams, and subgroups. This ensures broad industry representation and practical relevance. * **Version 3.1.0 Release Details:** The TMF Reference Model version 3.1.0 is a minor update, incorporating 23 approved change requests. Key enhancements include integrated dating conventions, country/trial/site level milestones, minor artifact name adjustments, and refined definitions to improve clarity and consistency. * **Stable Artifact IDs for Data Exchange:** Despite changes to artifact names or definitions, the underlying artifact ID numbers remain constant. This is critical for data mapping, migration, and the interoperability of TMF systems, particularly when using the Exchange Mechanism Standard (EMS). * **Importance of Detailed Release Notes:** Users are strongly encouraged to consult the detailed release notes for version 3.1.0, which provide comprehensive information on all changes, including old and new text, to understand the full scope of updates. * **Subgroup Progress and Future Outlook:** Active subgroups are addressing specific areas such as Non-Interventional Studies (NIS), Device TMFs, and the comprehensive definition of sub-artifacts. These efforts are expected to lead to future major releases incorporating new frameworks and guidelines. * **Framework for Paper Destruction:** A dedicated framework is being developed to guide the compliant destruction of paper TMF documents. This project involves creating tools like decision trees and policy templates, highlighting the industry's move towards digital solutions while managing legacy paper records. * **Exchange Mechanism Standard (EMS) Adoption:** The EMS team is actively promoting the standard through webinars and seeking sponsors, CROs, and vendors to pilot its implementation. This initiative aims to standardize the digital exchange of TMF content between different organizations and systems. * **Call for Volunteers:** The TMF Reference Model initiative consistently seeks volunteers for various roles, including reviewing sub-artifacts, participating in zone teams, and assisting with implementation projects like the paper destruction framework. This collaborative model is essential for its ongoing success. * **Impact of Minor Updates:** Minor updates like version 3.1.0 are unlikely to cause significant incompatibility issues with previous versions. Organizations do not necessarily need to immediately update their systems but can incorporate changes during planned TMF structure reviews. * **Feedback and Change Request Process:** The community is encouraged to submit feedback and change requests through a dedicated online forum, providing specific details (e.g., artifact numbers) to facilitate review by the Change Control Board. The forum is not for general questions, which should be directed to community groups. * **Consideration for Artifact-Level Versioning:** A discussion point raised the potential for versioning at the individual artifact level, rather than just the entire reference model. While challenging for non-technical users or paper-based systems, this could be beneficial for eTMF systems capable of tracking granular changes. Tools/Resources Mentioned: * MailChimp (for mailing lists/newsletters) * Yahoo Groups (for online discussions) * Groups.IO (for project team members) * TMF Reference Model Website (for general information, meeting details, and downloading ICS files) * Outlook/Google Calendar (for importing meeting details via ICS files) * Online Forum (for submitting feedback and change requests) Key Concepts: * **TMF Reference Model:** A standardized, hierarchical model for organizing and managing documents within a Trial Master File, ensuring consistency and regulatory compliance. * **Artifacts:** Individual documents or records within the TMF, each assigned a unique ID number. * **Sub-Artifacts:** More granular components or types of documents within a broader artifact category. * **Zones:** High-level categories within the TMF Reference Model (e.g., Study Management, Central Trial Documents). * **Change Control Board (CCB):** The governing body responsible for reviewing, approving, and managing changes to the TMF Reference Model. * **Exchange Mechanism Standard (EMS):** A standard designed to facilitate the digital exchange and interoperability of TMF content between different systems and organizations. * **Non-Interventional Studies (NIS):** Clinical studies where patients receive routine care, and data is collected without intervention, requiring specific TMF considerations. * **Device TMF:** The Trial Master File specific to medical device studies, which may have unique documentation requirements compared to pharmaceutical trials. * **Framework for Destruction of Paper:** A guideline or methodology for the compliant and systematic destruction of physical TMF documents, particularly relevant as organizations transition to electronic TMFs. * **Version Control (Maintenance, Minor, Major Changes):** A classification system used by the CCB to categorize the impact and scope of updates to the TMF Reference Model.
Pull Approved Content from Veeva Vault Promomats into Entatio.com
MediaManager
/@mediamanager465
Nov 14, 2018
This video provides an in-depth exploration of integrating Veeva Vault PromoMats with Entatio.com to streamline the distribution of regulatory-approved content for life sciences companies. The presenter begins by establishing the critical need for pharmaceutical and biotech firms to share promotional and educational materials, such as prescriber information and sales presentations, with healthcare providers while rigorously adhering to regulatory compliance. The core problem addressed is how to efficiently make content that has undergone Promotional Review Committee (PRC) approval available to an audience, ensuring that only approved and current versions are distributed. The tutorial then walks through the practical steps of connecting a Veeva Vault instance to Entatio.com. It highlights Veeva Vault's role as a popular regulatory document management system that facilitates the PRC review process for marketing content. By integrating these two platforms, Entatio ensures that any content shared with the healthcare community has been officially reviewed and approved for release. The demonstration includes navigating the Entatio interface to set up vault credentials, browse available content within the vault, and select specific media, such as an "interactive visual aid" (IVA) or "closed-loop marketing presentation," for import. A significant aspect of the integration is the capability for automated content synchronization. The video details how users can configure Entatio to automatically check for updates to the selected media in Veeva Vault on a scheduled basis (e.g., daily or weekly). This feature ensures that if any changes are approved in Veeva Vault, the distributed content in Entatio is automatically updated, and subscribers (such as healthcare providers) can be notified via email. The presentation concludes by illustrating how the content appears to the end-user and emphasizes the crucial integration with Veeva CRM, which allows life sciences companies to track specific individuals' engagement with the distributed media, thereby providing valuable insights for commercial operations. Key Takeaways: * **Ensuring Regulatory Compliance in Content Distribution:** The video underscores the paramount importance of distributing only Promotional Review Committee (PRC) approved content, especially for life sciences companies sharing sensitive information like prescriber data or sales presentations with healthcare providers. Veeva Vault PromoMats serves as the central hub for this regulatory approval process. * **Streamlined Content Integration from Veeva Vault:** Entatio.com offers a direct and user-friendly method to connect to Veeva Vault, enabling life sciences companies to pull approved media assets seamlessly. This integration simplifies the process of making compliant content available to a wider audience. * **Automated Content Synchronization for Accuracy:** A key feature demonstrated is the ability to schedule automatic updates, where Entatio periodically checks Veeva Vault for any changes to linked media. This ensures that the content presented to the audience is always the most current, PRC-approved version, minimizing the risk of distributing outdated or non-compliant materials. * **Enhanced Content Management and Organization:** Within Entatio, users can create "presentations" or collections of media, allowing for structured organization of content pulled from Veeva Vault. This facilitates easier management and distribution of various interactive visual aids (IVAs) or closed-loop marketing (CLM) presentations. * **Audience Subscription and Notification System:** The platform supports a subscription model where healthcare providers or other audience members can subscribe to specific content. Upon any update to the content in Veeva Vault (and subsequent automatic synchronization to Entatio), subscribers receive automated email notifications, keeping them informed of new information. * **Robust Engagement Tracking with Veeva CRM:** The integration extends to Veeva CRM, allowing life sciences companies to track individual user engagement with the distributed media. This provides critical data for sales and marketing teams, offering insights into which healthcare professionals are viewing specific content, thereby enhancing commercial operations and sales effectiveness. * **Flexible Content Embedding Options:** Approved content can be embedded into external websites, offering flexibility in how it is shared. This can be done with or without a registration screen, catering to different access control requirements and marketing strategies. * **Reference Numbering for Traceability:** When content is pulled from Veeva Vault, Entatio retains the original vault reference number. This ensures clear traceability back to the source document in the regulated system, which is crucial for audit trails and compliance verification. * **Optimized Content Marketing and Sharing:** By combining a regulatory document management system (Veeva Vault) with a content distribution platform (Entatio) and a CRM system (Veeva CRM), life sciences companies can achieve a more efficient, compliant, and insightful content marketing and sharing ecosystem. Tools/Resources Mentioned: * **Veeva Vault PromoMats:** A regulatory document management system widely used in the pharmaceutical and life sciences industries for managing and approving promotional and marketing content. * **Entatio.com:** A content distribution platform demonstrated in the video for sharing and tracking approved media with audiences, particularly within the healthcare community. * **Veeva CRM:** A customer relationship management platform, specifically mentioned for its integration with Entatio to track user engagement with distributed content. Key Concepts: * **Promotional Review Committee (PRC):** A critical internal process in life sciences companies where marketing and promotional materials are reviewed by medical, legal, and regulatory teams to ensure compliance with industry regulations and internal policies before public release. * **Interactive Visual Aid (IVA) / Closed-Loop Marketing (CLM) Presentation:** Digital sales tools used by pharmaceutical sales representatives during interactions with healthcare professionals. These are often interactive and designed to capture feedback or data, forming a "closed loop" of information. * **PII (Prescriber Information):** Personally Identifiable Information related to prescribers (healthcare professionals), which requires careful handling and compliance with data privacy regulations. * **Auto-Update Feature:** A mechanism that automatically synchronizes content from a source system (like Veeva Vault) to a distribution platform (like Entatio) whenever changes are made and approved in the source, ensuring content remains current.
Veeva Systems CEO: Modernizing Manufacturing | Mad Money | CNBC
CNBC Television
/@CNBCtelevision
Oct 18, 2018
This video features an interview with Peter Gassner, founder and CEO of Veeva Systems, on CNBC's Mad Money, discussing the company's significant growth and strategic direction within the life sciences industry. Jim Cramer positions Veeva as a leading cloud-based software provider for pharmaceutical, biotech, and life sciences companies, highlighting its role in enhancing pharmaceutical sales effectiveness, capturing clinical trial data, and ensuring compliance with government regulations. The conversation underscores Veeva's impressive financial performance, including tripling products, quadrupling revenues, and sextupling profits over five years, achieving its billion-dollar revenue goal a year ahead of schedule. Gassner elaborates on Veeva's expansion strategy, likening it to the successful models of Salesforce and Adobe, by developing both a "development cloud" and a "commercial cloud" tailored for the life sciences sector. A central theme is the industry's ongoing digital transformation, moving away from outdated paper-based processes that have historically burdened highly regulated fields. He emphasizes that while life sciences is a serious, $1.6 trillion business focused on improving human life, many critical procedures, especially those related to patient safety and regulatory compliance, have remained manual. Veeva's mission is to modernize these processes with cloud software, making operations more efficient and improving job satisfaction for professionals in these companies. The interview also explores Veeva's strategic move to expand its market beyond traditional life sciences. Gassner introduces "Quality One," a product designed to address similar paper-based and client-server burdens in the manufacturing and distribution processes of other regulated industries, such as cosmetics, chemicals, and consumer packaged goods. This expansion signifies a broader recognition of the need for specialized cloud solutions in any sector where careful manufacturing and distribution are critical and subject to stringent oversight, indicating a vast untapped market for Veeva's expertise in regulated enterprise software. Key Takeaways: * **Dominant Cloud Software Provider:** Veeva Systems is a leading cloud-based software company specifically serving the pharmaceutical, biotech, and life sciences industries, demonstrating sustained growth and market leadership. Its offerings span critical functions like commercial operations, clinical trial data management, and regulatory compliance. * **Strategic Expansion and Growth:** Veeva has achieved remarkable growth, tripling its product offerings, quadrupling revenues, and sextupling profits in five years, reaching its billion-dollar revenue target ahead of schedule. This growth is fueled by a strategic expansion into both "development cloud" and "commercial cloud" solutions. * **Digital Transformation in Life Sciences:** The life sciences industry, despite its forward-thinking nature in research, has historically relied heavily on paper-based processes for regulatory compliance and operational procedures, particularly concerning patient safety. This presents a significant opportunity for digital modernization through specialized cloud software. * **Regulatory Compliance as a Driver:** The inherent regulatory complexity of the life sciences sector (e.g., FDA, EMA, GxP) necessitates robust, compliant software solutions. Veeva's success is partly attributed to its ability to help clients navigate and comply with these stringent government regulations, moving away from inefficient manual systems. * **Replicating Successful SaaS Models:** Veeva's strategy mirrors the expansion models of tech giants like Salesforce and Adobe, by continuously innovating and expanding its product portfolio within its niche, thereby deepening customer relationships and increasing its total addressable market. * **Modernizing Manufacturing Beyond Pharma:** Veeva is extending its expertise beyond core life sciences with its "Quality One" product, targeting manufacturing and distribution in other regulated industries such as cosmetics, chemicals, and consumer packaged goods. This indicates a broader market need for cloud-based solutions to replace outdated paper and client-server systems in quality-critical environments. * **Impact on Employee Efficiency and Satisfaction:** Modern cloud software not only enhances operational efficiency and compliance but also improves the daily work experience for professionals in life sciences, allowing them to focus more on their core mission of making medicines and less on administrative burdens. * **Vast Untapped Market for Regulated Software:** The discussion highlights a significant market opportunity in providing specialized, compliant cloud software for any industry with complex, regulated manufacturing and distribution processes that are currently hampered by legacy systems. * **Importance of Industry-Specific Solutions:** The success of Veeva underscores the value of deeply understanding a specific industry's unique challenges, regulatory landscape, and operational needs to develop tailored software solutions that generic platforms cannot adequately address. Tools/Resources Mentioned: * **Veeva CRM:** A leading platform for pharmaceutical commercial operations. * **Veeva Vault:** A suite of cloud applications for content and data management across R&D, clinical, quality, and commercial operations. * **Quality One:** A new Veeva product aimed at modernizing quality and manufacturing processes in regulated industries beyond life sciences (e.g., cosmetics, chemicals, CPG). * **AWS (Amazon Web Services):** Mentioned as a common cloud migration target, implying Veeva's own cloud infrastructure is robust and modern. Key Concepts: * **Commercial Cloud:** Software solutions focused on sales, marketing, and customer relationship management within an industry. * **Development Cloud:** Software solutions supporting research and development, particularly in areas like clinical trials and regulatory submissions. * **Digital Transformation:** The process of adopting digital technology to fundamentally change how an organization operates and delivers value. * **Regulatory Compliance:** Adherence to laws, regulations, guidelines, and specifications relevant to a particular industry, crucial in life sciences for patient safety and product efficacy.
VISEVEN | 2018 | Webinar | Evolve your expertise in Veeva
Viseven
/@VisevenMarTech
Oct 2, 2018
This webinar, presented by Viseven, focuses on evolving Veeva expertise, particularly in managing multichannel content for pharmaceutical and life sciences companies. The speaker introduces e-Wizard, a unique platform designed to simplify content creation, localization, adaptation, and publishing to various Veeva solutions such as Veeva CRM, Veeva Vault PromoMats, Veeva Approved Email, Veeva CLM, Veeva CoBrowse, and Veeva MyInsights. The discussion highlights how e-Wizard addresses common challenges like the need for specialized knowledge, human resources, and high costs associated with traditional content management, offering a solution that streamlines workflows, ensures compliance, and provides actionable insights for commercial operations. Key Takeaways: * **Veeva Ecosystem Integration:** The e-Wizard platform offers deep, two-way integration with a comprehensive suite of Veeva solutions (CRM, Vault PromoMats, Approved Email, CLM, CoBrowse, MyInsights), enabling seamless content management and data synchronization across the pharmaceutical commercial ecosystem. * **Content Lifecycle Optimization:** e-Wizard drastically simplifies and accelerates the content lifecycle, from creation and localization to approval and publishing, by providing tools for converting various file types to HTML5 CLM, managing a global store of approved content, and offering a component-based templating approach for consistent branding and efficient adaptation. * **Enhanced Commercial Operations & Analytics:** The platform supports the creation of interactive presentations, remote visits, and customizable dashboards (leveraging Veeva MyInsights) to deliver targeted interactions, track detailed KPIs (e.g., slide duration, prescriptions, email open rates), and provide rich analytics for real-time monitoring of communication channel efficiency. * **Reduced Operational Overhead:** By automating content publishing and providing flexible tools, e-Wizard aims to reduce reliance on external agencies, minimize administrative work, and significantly cut down the time and cost associated with managing and deploying compliant marketing and sales content within the regulated life sciences industry. * **Compliance and Reusability:** The platform emphasizes the use of approved content, master templates, and a component library to ensure global branding consistency, facilitate effortless localization, and maintain regulatory compliance while maximizing content reusability across different channels and regions.
A Day in the Life of a TMF Document Overview
LMK Clinical Research Consulting
/@lmkclinicalresearchconsult7189
Sep 27, 2018
This video provides an in-depth exploration of the Trial Master File (TMF) document lifecycle, emphasizing its critical role in clinical studies and inspection readiness. Presented by Jack Morell, Director of Clinical Operations at LMK Clinical Research Consulting, the webinar systematically breaks down the TMF journey from infrastructure and document creation to ongoing quality control, metrics, and ultimately, regulatory inspections. Morell argues that the TMF is arguably the most important aspect of a clinical study, serving as the foundation for assessing trial conduct, data integrity, and compliance with Good Clinical Practice (GCP). The presentation begins by establishing the foundational TMF infrastructure, detailing the essential processes and tools required for continuous inspection readiness. This includes formally documented SOPs, work instructions, and job aids, alongside mandatory training for all TMF personnel. Key expectations for TMF timeliness, quality, and completeness are defined, with a strong recommendation for using TMF indices—such as the TMF Reference Model or Oasis Reference Model—to outline all expected documentation beyond the basic ICH GCP Section 8 list. The discussion then moves into the document's lifecycle, from its creation and initial QC by the submitter to its proper indexing and submission into the TMF, highlighting specific quality criteria for both paper and electronic documents, including considerations for hyperlinks and image quality for scanned files. A significant portion of the webinar is dedicated to TMF Quality Control (QC), distinguishing between a mere inventory and a true, comprehensive review. Morell stresses the importance of proactive, ongoing QC throughout the study's duration, utilizing tools like storyboards and expected document lists to identify missing documentation. He outlines three types of QC—prospective, retrospective, and oversight—and various timing approaches (milestone, calendar, phase, risk-based). The speaker also addresses the common misuse of "notes to file," advocating for prompt and thorough corrective actions. The final segments delve into the power of TMF metrics for gauging overall TMF health, providing examples of quality metrics broken down by protocol, site, functional line, and QC finding type, and how these can trigger process improvements or retraining. The webinar concludes with a focus on inspection readiness, reiterating that preparation starts on day one and offering practical do's and don'ts for navigating regulatory inspections by agencies like the FDA, MHRA, and EMA, noting how eTMF systems offer inspectors real-time visibility into filing activities. Key Takeaways: * **TMF as the Foundation of Clinical Studies:** The TMF is not merely a collection of documents but the core evidence for assessing clinical trial conduct, data integrity, and GCP compliance, making it paramount for regulatory inspections. * **Robust TMF Infrastructure is Crucial:** Establish formally documented processes (SOPs, work instructions, job aids) and ensure all personnel are trained. This sets the stage for continuous inspection readiness from day one. * **Define Clear Expectations:** TMF processes must clearly define expectations for document timeliness (e.g., submission deadlines), quality (QC criteria, acceptable error rates), and completeness (all expected documentation). * **Utilize TMF Indices:** Go beyond ICH GCP Section 8. Implement a comprehensive TMF index (e.g., TMF Reference Model, Oasis Reference Model) tailored to company SOPs to outline all expected documentation and assign filing responsibilities. * **Quality Starts at Creation:** Every document creator should perform an initial QC before submission to the TMF. This proactive approach minimizes downstream issues and ensures quality standards are met. * **Comprehensive Document QC Criteria:** Beyond basic checks, QC should confirm document appropriateness, finality, completeness (all fields, signatures), legibility, correct page order, and redaction of PII. Special considerations apply to electronic documents (hyperlink functionality, compatible formats, unlocked files) and scanned paper documents (image quality, orientation). * **Continuous TMF QC is Essential:** Implement prospective and oversight QC throughout the study, not just at the end. Use tools like storyboards and expected document lists to identify gaps and ensure ongoing inspection readiness. * **Prompt Corrective Action:** "Find it, fix it" is the motto for QC findings. Resolve issues promptly, ideally within 30 days, as delays can make resolution difficult (e.g., personnel leaving the company). * **Avoid Overuse of "Notes to File":** Notes to file are rarely sufficient for closing QC findings. If used, they must be informative, detailing the issue, attempts to remedy it, and corrective actions to prevent recurrence. * **Leverage TMF Metrics for Health Assessment:** Implement a metrics program (starting simple with quality, completeness, timeliness) to gauge overall TMF health. Metrics can identify systemic issues, prompt process improvements, retraining, or resource allocation changes. * **Inspection Readiness is Day-One Responsibility:** Preparation for inspections begins at the start of the study. Ensure adherence to GCP, understand regulatory environments, follow established SOPs, and have a TMF index and plan in place. * **Beware of Inspection Pitfalls:** Avoid relying solely on ICH GCP, making assumptions about regulations, passing all responsibility to CROs (sponsors are ultimately accountable), or panic-filing documents just before an inspection, as eTMF systems provide inspectors visibility into filing timelines. * **Strategic Inspection Conduct:** During an inspection, only answer questions related to your role, avoid volunteering unrequested information, and do not comment on quality issues or admit non-compliance. Never fabricate documents. Tools/Resources Mentioned: * **TMF Reference Model (DIA Reference Model):** A commonly used industry model for TMF structure. * **Oasis Reference Model:** Mapped structurally to the TMF Reference Model, with added metadata. * **SOPs, Work Instructions, Job Aids:** Formal documentation for TMF processes. * **TMF Indices:** Study-specific roadmaps for expected documentation and filing locations. * **TMF QC Plan:** Defines who, what, and when for QC activities. * **TMF QC Tracker:** Used to document QC findings and their resolution. * **QC Certificate:** Documentation filed in the TMF confirming a QC review was performed. * **Storyboard:** Tracks unique study information, milestones, and events. * **Expected Document List:** Generated at study start and updated to track anticipated documentation. * **eTMF Platforms:** Electronic Trial Master File systems, often configured with reference models, allowing for tracking QC and metrics. * **Excel/SharePoint:** Can be used for TMF QC trackers. Key Concepts: * **TMF (Trial Master File):** A collection of essential documents that individually and collectively permit the reconstruction of the conduct of a clinical trial. * **eTMF (Electronic Trial Master File):** A digital system for managing TMF documents, offering benefits like real-time visibility and access. * **GCP (Good Clinical Practice):** An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. * **ICH GCP Section 8:** A section within the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6(R2) guideline that lists essential documents for the clinical trial. * **Prospective QC:** Ongoing quality control performed regularly throughout the study's duration. * **Retrospective QC:** Quality control performed after a period of non-ongoing QC, generally not recommended. * **Oversight QC:** QC performed by a sponsor on a CRO's TMF, or by a QA group, to ensure adherence to processes. * **Note to File (NTF):** A document used to explain minor deviations or missing information in the TMF, which should be informative and detail corrective actions. Examples/Case Studies: * **Quality Metric Breakdown:** Examples of TMF quality metrics were shown, illustrating how a total document failure rate (e.g., 8% exceeding a 5% threshold) can be broken down by document level, functional line (e.g., country and site management team having a higher error rate), or QC finding type (e.g., high number of duplicate documents indicating unclear filing responsibilities). * **Inspection Readiness Pitfall - Panic Filing:** A graph from Andy Fisher (MHRA inspector) demonstrated a significant spike in document filing immediately before an inspection date, highlighting how eTMF systems reveal such activities to inspectors and can lead to findings.
10 Ways to Revamp Your TMF QC Process
LMK Clinical Research Consulting
/@lmkclinicalresearchconsult7189
Sep 27, 2018
This video provides an in-depth exploration of how to revamp the Trial Master File (TMF) Quality Control (QC) process, emphasizing its critical role in ensuring regulatory compliance and inspection readiness for clinical trials. Julia Devan, President and CEO of LMK Clinical Research Consulting, guides attendees through the "why" and "how" of effective TMF QC, drawing upon her extensive industry experience and LMK's specialized services. The presentation highlights common pitfalls in TMF management, such as delayed filing and inconsistent QC practices, and offers a structured approach to overcome these challenges. The discussion begins by underscoring the importance of TMF QC, citing regulatory expectations from agencies like the MHRA and EMA, which mandate that TMFs be complete and updated in a timely manner, contemporaneous with the clinical trial. Devan illustrates the common problem of documents being filed only at the end of a study or in anticipation of an inspection, stressing the need for a linear distribution of TMF documents throughout the trial. She then delves into the difficulties associated with TMF QC, such as defining clear expectations for document versions, piecing together the study narrative, and navigating centralized versus decentralized QC models, where either a dedicated team or functional lines perform the review. The core of the webinar is a detailed breakdown of ten actionable strategies to enhance TMF QC. These strategies cover foundational elements like developing a comprehensive TMF QC plan, utilizing appropriate tools (e.g., a company-specific TMF Table of Contents mapped to the TMF Reference Model), and ensuring qualified personnel are performing QC. Devan emphasizes the importance of consistent timing for QC activities, standardization of pass/fail criteria, and establishing quality levels with associated risk assessments. A key concept introduced is linking TMF documents to study milestones and events to better define expectations for completeness. The presentation culminates with the necessity of performing a "true review" of the TMF, going beyond a mere inventory check, and implementing prompt, verifiable corrective actions for any identified discrepancies to maintain a constant state of inspection readiness. Key Takeaways: * **TMF QC is Paramount for Compliance:** The Trial Master File (TMF) is the foundation for regulatory inspections, and its quality control is essential for demonstrating patient rights and safety protection, as well as data reliability, aligning with ICH GCP R2 and expectations from agencies like the EMA and MHRA. * **Timeliness is a Regulatory Mandate:** Regulatory bodies expect the TMF to be contemporaneous with the clinical trial, meaning documents should be filed and updated in a timely, ongoing manner, not accumulated and filed en masse at the study's conclusion. * **Address Common QC Challenges:** Many organizations struggle with TMF QC due to difficulties in defining document expectations (e.g., number of versions), piecing together the study's story, and resource constraints, highlighting the need for a structured approach. * **Develop a Comprehensive TMF QC Plan:** A robust QC plan should detail who is responsible, how QC is performed, logistical controls (e.g., expected number of document iterations), timing, and the process for results and corrective actions, and should be system and file structure agnostic. * **Leverage Appropriate Tools:** Utilize a company-specific TMF Table of Contents (mapped from the TMF Reference Model), a list of study SOPs with start/stop dates, and study reference documents (protocol, CTMS data, country lists) to guide the QC process and define expectations. * **Prioritize Qualified and Trained Personnel:** Effective TMF QC requires experienced individuals who understand clinical trials and the specific study, supported by thorough training to ensure consistent review, whether in a centralized or decentralized QC model. * **Establish a Sustainable QC Schedule:** Implement a consistent and manageable QC schedule aligned with company SOPs and document lifecycles, avoiding overburdening staff and ensuring documents are not reviewed redundantly to prevent frustration and non-compliance. * **Standardize Pass/Fail Criteria:** Clearly define what constitutes a "pass" or "fail" for TMF documents based on criteria such as presence, complete signatures, complete fields, and adherence to dating conventions, ensuring consistency across all reviewers. * **Calculate and Track TMF Quality:** Implement a system to calculate TMF QC pass/fail rates for each study, creating a quality score that helps track improvement or decline over time and informs necessary interventions, while also considering the risks associated with missing or poor-quality documents. * **Link Documents to Milestones and Events:** Assign each TMF document to a specific study milestone (e.g., first subject first visit) or event (e.g., protocol amendment) to clearly define when documents are expected to be filed, aiding in completeness checks and timely filing. * **Perform a "True Review," Not Just Inventory:** TMF QC should go beyond a simple inventory check. It requires an in-depth review of documentation against study context, operational plans (e.g., monitoring plan), and regulatory requirements to ensure accuracy, completeness, and proper location. * **Implement Prompt Corrective Actions:** "If you find it, fix it." Discrepancies should be corrected as soon as possible, ideally within two weeks, by following up with responsible parties, verifying corrections, and documenting due diligence if a correction is impossible (e.g., in a monitoring visit report, not a note to file). * **Technology is a "Frenemy":** While eTMF systems offer advanced functionalities, they are only effective when supported by proper processes and trained people. Organizations should ensure their technology works for them, rather than working for the technology. * **Sponsor Oversight is Non-Negotiable:** Under ICH GCP R2, sponsors are ultimately responsible for the TMF, even if delegated to a CRO or FSP. Sponsors must have a TMF QC plan and processes in place to demonstrate effective oversight of their partners. **Tools/Resources Mentioned:** * **TMF Reference Model:** An industry standard for TMF structure and content. * **CTMS (Clinical Trial Management System):** Used to track study progress and provide information relevant to TMF QC. * **Excel Trackers:** Mentioned as a historical or alternative method for managing study information. * **LMK's TMF Complete Service:** A comprehensive TMF QC review process based on ICH GCP R2 and Six Sigma principles. * **LMK's TMF University Program:** An award-winning training program with 18 TMF courses across three learning levels. * **Claire:** An AI chatbot feature on LMK's website for TMF questions. **Key Concepts:** * **TMF QC Plan:** A documented strategy outlining how TMF quality control will be performed, including responsibilities, timing, methods, and corrective actions. * **Centralized vs. Decentralized QC:** Two models for TMF QC: centralized involves a dedicated group (potentially not involved in the study), while decentralized involves functional lines or document owners performing QC on their own documents. * **Milestones and Events (in TMF context):** Specific points in a clinical trial (milestones like first subject first visit) or occurrences (events like a PI change) that trigger the creation or collection of specific TMF documents. * **True Review:** An in-depth assessment of TMF documents that goes beyond a simple inventory check, evaluating content against study context, operational plans, and regulatory requirements. * **Frenemy (Technology):** A term used to describe technology (like eTMF systems) that, while powerful, can become a hindrance if not supported by proper processes and trained personnel. **Examples/Case Studies:** * **Delayed TMF Filing Graph:** A visual representation showing a common pattern where TMF documents are filed late in a study, with significant upticks only at the end or during inspections, instead of a linear, contemporaneous filing. * **TMF QC Pass/Fail Calculation:** An example of how to create and calculate a quality score for each study by tracking passes and fails, allowing for ongoing assessment of TMF health and identification of areas for improvement. * **Subject Questionnaire QC Process:** A detailed walkthrough of how to perform a true review for a specific document type (subject questionnaires), considering protocol information, required iterations, translations, and IRB approvals.
Simplifying the Management of Complex SPOR Data
Asphalion
/@Asphalion.
Sep 17, 2018
This video provides an in-depth exploration of simplifying the management of complex SPOR (Substances, Products, Organizations, Referential) data, a critical component of the EMA's ISO IDMP (Identification of Medicinal Products) implementation. The webinar, presented by Remco Munnik from Asphalion and Gary Wilson from CorrIT, introduces "SPORIFY," an off-the-shelf software solution designed to automate the matching, synchronization, and integration of local company data with the EMA's SPOR master data. The core problem addressed is the significant challenge pharmaceutical and life sciences companies face in transitioning from xEVMPD to IDMP, which necessitates robust management of controlled vocabularies and organizational data provided by the EMA. The presentation begins by setting the theoretical context of ISO IDMP and the role of SPOR as a master data system to achieve structured data for medicinal products. SPOR is broken down into its four domains, with a particular focus on Organizations (lists of marketing authorization holders, sponsors, manufacturers) and Referential (over 100 controlled vocabularies like dosage forms, routes of administration, countries). The speakers emphasize the benefits of master data, including improved analytics, more efficient regulatory decision-making, operational savings, better data quality, and alignment with future data standards, highlighting the current lack of standardization across departments and companies as a major hurdle. Gary Wilson then provides a live demonstration of the SPORIFY tool, showcasing its user-friendly, non-technical interface. The demo illustrates how companies can upload their local data (e.g., units of measure, countries, pharmaceutical dose forms, organizations with addresses) using simple Excel templates. SPORIFY automatically matches this local data with EMA SPOR data, providing immediate feedback on compliance rates, suggested matches, and unmatched items. For organizations, the tool handles the complexity of matching both organization names and multiple associated locations simultaneously. The system also supports manual matching, allows users to define custom "resolution statuses" for data governance (e.g., "for review," "approved," "change request needed"), and provides export options (Excel or API) for integrating the mapped data back into internal systems. A key feature demonstrated is SPORIFY's continuous synchronization capability, which automatically checks the EMA SPOR systems daily for updates. This ensures that any changes to controlled vocabularies or organization details are detected, and the system can automatically update matched records or notify users of changes to "favorited" organizations. The discussion also touches upon different master data integration models (registry, repository, hybrid) and how SPORIFY can support each, reducing manual effort and improving data accuracy. The overall process cycle for master data management—Identify, Match, Maintain, Govern, Integrate, and Synchronize—is presented, with SPORIFY significantly automating the synchronization and maintenance steps. Key Takeaways: * **ISO IDMP and SPOR are Imminent:** Despite perceived delays, the EMA's SPOR data is actively being utilized and is foundational for the upcoming ISO IDMP implementation, making proactive data management crucial for pharmaceutical companies. * **SPOR Data Domains:** SPOR encompasses Substances, Products, Organizations, and Referential data. Organizations (MAHs, sponsors, manufacturers) and Referential (over 100 controlled vocabularies like dosage forms, countries) are currently live and require active management. * **Benefits of Master Data:** Implementing master data management for SPOR leads to better analytics, more efficient regulatory actions, operational savings, improved data quality, and easier alignment with evolving data standards. * **Standardization is Key:** Standardized product data is essential not only for regulatory activities (e-submissions, variations) but also for critical functions like e-prescription, serialization, tracking shortages, managing recalls, inspections, and pharmacovigilance. * **The Challenge of Dynamic Data:** EMA's SPOR data, particularly for organizations, is constantly updated, changed, and added daily, posing a significant challenge for companies to manually track and maintain alignment with their internal systems. * **SPORIFY's Automated Matching:** The tool automates the matching of local company data (from Excel or databases) with EMA SPOR data, providing immediate insights into data compliance and suggesting potential matches based on similarity. * **Comprehensive Mapping for Organizations:** SPORIFY addresses the complexity of organization mapping by simultaneously matching organization names and associated locations, even when addresses are formatted differently in source systems. * **Customizable Data Governance:** Users can define and apply custom "resolution statuses" (e.g., "for review," "approved," "change request") to unmatched or suggested items, enabling internal workflows and governance processes for data quality. * **Continuous Synchronization:** SPORIFY automatically synchronizes with EMA SPOR systems twice daily, detecting changes and updating matched records or notifying users, thereby eliminating the manual burden of tracking updates. * **Flexible Integration Options:** The system supports various master data integration models (registry, repository, hybrid) and offers data export via Excel or an Application Programming Interface (API) for seamless integration with internal systems. * **"Favorites" for Critical Monitoring:** Users can "favorite" specific organizations or locations to receive special alerts for any changes, providing targeted monitoring for critical entities. * **Reduced Manual Effort:** By automating matching and synchronization, SPORIFY significantly reduces the manual effort, potential for user errors, and time required to maintain compliance with EMA's evolving SPOR data. * **Future Roadmap:** The solution plans to incorporate xEVMPD substance lists for preparation and will develop interfaces for the Substances (S) and Products (P) domains as they become available from the EMA. Tools/Resources Mentioned: * **SPORIFY:** A software solution developed by CorrIT for managing EMA SPOR data. * **Excel:** Used for uploading local data into SPORIFY via templates and for exporting matched data. * **API (Application Programming Interface):** Offered by SPORIFY for machine-to-machine integration with local systems. Key Concepts: * **ISO IDMP (Identification of Medicinal Products):** A set of five ISO standards for the unique identification of medicinal products globally, mandated by the EMA. * **SPOR (Substances, Products, Organizations, Referential):** The EMA's master data system providing controlled vocabularies and master data for IDMP implementation. * **Organizations (O):** A list of all organizations (MAHs, sponsors, regulatory authorities, manufacturers) with unique IDs and locations. * **Referential (R):** A list of over 100 controlled vocabularies (e.g., dosage forms, routes of administration, countries, languages) used in regulatory submissions. * **xEVMPD (Extended EudraVigilance Medicinal Product Dictionary):** The current system for medicinal product data submission to the EMA, which IDMP will supersede. * **Master Data:** Non-transactional information (like SPOR data) considered key to core business operations and reused for multiple purposes, aiming for a "single source of truth." * **Resolution Statuses:** User-defined categories within SPORIFY to manage the workflow and governance of matched or unmatched data (e.g., "approved," "for review," "change request"). * **Registry System (Master Data Integration):** Each local system maintains its own copy of data and looks up to a central hub (like SPORIFY) for the single source of truth. * **Repository System (Master Data Integration):** Master data is moved out of local systems and maintained in a single central hub, which then feeds updates back into all connected systems. * **Hybrid Approach (Master Data Integration):** A mix of registry and repository models, accommodating both older and newer systems within an organization. Examples/Case Studies: * **Barcelona Benguela vs. Barcelona Spain:** Used to illustrate the importance of master data for unique identification, preventing errors like booking a flight to the wrong city. * **"Capsule" vs. "Hard Capsule":** Highlights the lack of standardization within different departments or companies, which SPOR aims to resolve by providing one unique term (e.g., "capsule, hard") with a unique ID and assigned synonyms. * **One A Pharma (Example Organization):** Used in the demo to show how users can "favorite" an organization to receive special alerts for any changes to its data on SPOR.
Transform Change Management with a Modern QMS
Veeva Systems Inc
/@VeevaSystems
Jul 31, 2018
This video provides an in-depth exploration of transforming change management within the life sciences industry through the adoption of a modern Quality Management System (QMS). Presented by Veeva Systems, the webinar highlights the critical challenges faced by pharmaceutical and biotech companies, such as the overwhelming volume and complexity of changes, particularly post-marketing approval. Speakers Robert Getna and Timur Sojustak detail how traditional, siloed, and document-centric approaches hinder innovation and efficiency, leading to significant backlogs, unpredictable lead times, and a high risk of non-compliance. The core of the presentation focuses on Veeva's solution, Vault Quality, which aims to revolutionize change management by fostering cross-functional and global collaboration on a unified, cloud-based platform. This approach emphasizes a fundamental shift from handling documents to managing structured data, and subsequently, leveraging this data for actionable intelligence. The speakers illustrate how an integrated system can provide real-time insights across quality, regulatory, and other critical functions, enabling seamless information exchange and proactive decision-making. The discussion extends to the importance of harmonizing regulatory approaches, citing initiatives like ICH Q12, and the necessity of engaging external partners like Contract Manufacturing Organizations (CMOs) in a more integrated manner. A significant portion of the webinar is dedicated to a live demonstration of Veeva Vault Quality, showcasing its capabilities for impact and risk assessment. The demo illustrates the use of dynamic, context-aware checklists that guide users through the assessment process, automatically identifying regulatory impacts and linking to related regulatory events within Veeva Vault RIM. This integration allows for automated impact assessments on affected markets and registrations, streamlining a traditionally complex and manual process. The presentation concludes by emphasizing the value of data-driven dashboards for gaining a high-level overview of change control status, identifying risks, and analyzing trends across multiple changes, thereby enhancing overall organizational understanding and control. Key Takeaways: * **Magnitude of Change Management Challenges:** Life science companies face immense pressure with over 200 changes per product annually, potentially leading to 40,000 change requests per year for top pharma companies. Implementation rates are often below 50%, resulting in long lead times and significant backlogs. * **Criticality of Post-Approval Changes:** Changes occurring after marketing approval are highly formalized and complex, often taking months or even years to implement. This bottleneck significantly hinders continuous improvement and innovation, as highlighted by nearly 100% of survey participants in 2017 stating their current processes impede progress. * **Limitations of Existing Solutions:** Traditional QMS implementations are often point solutions with siloed functions, leading to disconnects between quality and regulatory processes. A significant portion (83%) of companies still rely on hybrid data collection, mixing structured data with unstructured, paper-centric documents, which prevents effective data analysis and real-time insights. * **Three Pillars of Transformation:** A modern approach to change management requires three fundamental shifts: moving from siloed, local processes to cross-functional and global collaboration; transitioning from document handling to structured data handling; and leveraging data to generate actionable intelligence. * **Unified Platform for End-to-End Processes:** Implementing a unified, cloud-based platform (like Veeva Vault Quality and Vault RIM) is crucial for managing end-to-end change and variation processes. This platform enables real-time insights, seamless information exchange between quality, regulatory, and other stakeholders, and supports external collaboration with CMOs and suppliers. * **Data as the Master Record:** The concept of transforming documents into structured data, especially for content like specifications, is vital. This allows for granular assessment and tracking of changes, building intelligence into processes (e.g., dynamic checklists), and ensuring data integrity across the product lifecycle, rather than relying on static document representations. * **Smart and Dynamic Checklists:** Electronic checklists can be configured to be dynamic and context-aware, guiding users through impact and risk assessments. These checklists can leverage regulatory guidance, best practices, and historical data to define criticality, identify stakeholders, propose actions, and even trigger subsequent process steps based on responses. * **Integrated Quality System Benefits:** A fully integrated quality system connects change management to other quality processes (e.g., deviations, CAPAs) and links changes to their targets (products, organizations, equipment, documents). This connectivity provides comprehensive visibility and the ability to generate protocols and impact assessments on demand. * **Automated Regulatory Impact Assessment:** Modern QMS solutions, when integrated with regulatory information management (RIM) systems, can automatically assess the impact of changes on registered products, markets, and submissions. This significantly reduces manual effort and ensures comprehensive regulatory compliance. * **Data-Driven Dashboards for Insights:** Aggregating data from various change controls into reports and dashboards provides a high-level overview of current activities, identifies past-due changes, analyzes impacted areas (commercial, manufacturing), and visualizes assessment data (e.g., product impact, quality impact severity). * **External Partner Collaboration:** While systems enable deep collaboration with external partners, the level of information disclosure and integration depends on an organization's maturity and specific policies. Proactive sharing of change planning and assigning actions within the system can significantly improve predictability and compliance. * **Inspector Acceptance of Digital Records:** Shifting from document-centric to data-centric records requires proving compliance with regulations like 21 CFR Part 11 and EU GMP Annex 11. Education and clear demonstration of controls, audit trails, and electronic signatures are key to gaining acceptance from regulatory inspectors. Tools/Resources Mentioned: * **Veeva Vault Quality:** A modern QMS system designed for the life sciences industry. * **Veeva Vault RIM (Regulatory Information Management):** A system for managing end-to-end regulatory processes, including submissions and registrations, integrated with Vault Quality. * **ON24:** The webinar platform used for the presentation. Key Concepts: * **Change Management:** The systematic process of managing changes to a product, process, or system within an organization, particularly critical in regulated industries like life sciences. * **QMS (Quality Management System):** A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. * **Post-Approval Changes:** Modifications made to a drug product, manufacturing process, or quality system after initial marketing approval, which require formal assessment and regulatory notification/approval. * **Regulatory Variations:** Changes to a product's marketing authorization that must be submitted to regulatory authorities (e.g., FDA, EMA). * **ICH Q10/Q12:** International Council for Harmonisation (ICH) guidelines related to Pharmaceutical Quality System (Q10) and Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (Q12), emphasizing a harmonized approach to change management across the product lifecycle. * **GxP (Good x Practice):** A collection of quality guidelines and regulations (e.g., Good Manufacturing Practice, Good Clinical Practice) that ensure products are safe and meet quality standards. * **21 CFR Part 11:** Regulations issued by the FDA that set forth the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. * **EU GMP Annex 11:** European Union guidelines on computerized systems used in pharmaceutical manufacturing, ensuring data integrity and system validation. * **Product Lifecycle Management (PLM):** The process of managing the entire lifecycle of a product from its conception, through design and manufacture, to service and disposal, including all associated data and information. * **Document-centric vs. Data-centric:** A shift from relying primarily on static documents for information storage and process execution to utilizing structured data that can be dynamically analyzed, linked, and leveraged for intelligence. * **Smart Checklists:** Dynamic, electronic checklists that adapt based on user input, context, and predefined rules, providing guided assessments and automating subsequent process steps. Examples/Case Studies: * **New Manufacturer for a Product (Voltovio Salt):** The live demonstration used a scenario involving a change control for a new manufacturer of a product called "Voltovio Salt." This example illustrated how to perform an impact and risk assessment, run a guided checklist, and assess regulatory impact across different markets. * **Change of a Limit in Specifications:** The speakers discussed how a change in a limit for established acceptance criteria in a product specification is more critical than changing an internal reference. This highlights the need for granular data management and dynamic guidance in impact assessment. * **Impact Assessment on Registered Products:** The demo showed how Veeva Vault RIM could automatically generate an impact assessment report, listing all affected markets and approved registrations (e.g., US, Germany, France, Malaysia, Belgium) for a regulatory event linked to a change control.
The Benefits of an Electronic Quality Management System (EQMS)
TIP Technologies
/@tiptechnologies3178
Jul 13, 2018
This video provides an in-depth exploration of the benefits of implementing an Electronic Quality Management System (EQMS) in modern manufacturing environments. The presentation begins by establishing the challenging context of fierce global competition and increasing customer demands, highlighting how a lack of effective control over the product lifecycle inevitably leads to quality faltering. It positions an EQMS as a crucial solution for ensuring manufacturing success by digitizing record-keeping and eliminating error-prone paper-based processes. The core of the video details how an EQMS streamlines various critical aspects of quality management. It emphasizes the system's ability to manage compliance and regulatory requirements, such as ISO, D FAR's, and AS-90100D, which is invaluable in rapidly evolving regulatory landscapes and significantly reduces audit concerns. The discussion progresses to highlight the improvements in cross-functional communication and data transparency, achieved through real-time access to quality and manufacturing data. This unified view, often facilitated by effective ERP integration, creates a "single source of the truth," ensuring consistent quality processes from source inspection through final device approval. Furthermore, the video delves into specific operational advantages, such as the electronic management of inspection steps, preventing the circulation of outdated paper records. It explains how failed criteria can be immediately recorded as nonconformities, placing material on hold and initiating electronically tracked corrective actions with detailed task plans. The importance of traceability is underscored, with an EQMS managing the complete genealogy of every part, sub-assembly, and final assembly. The system also ensures document revision control, making the latest approved documentation always available, and supports periodic review requirements and controlled approval processes. Finally, the presentation touches upon enhanced supply chain visibility, supplier performance tracking, calibration management for measurement tools, and comprehensive employee training management, all contributing to higher product quality and operational excellence. Key Takeaways: * **Elimination of Paper-Based Processes:** An EQMS digitizes quality management, eliminating lost documents, filing errors, and outdated paper records, thereby ensuring higher product quality and operational efficiency. * **Streamlined Regulatory Compliance:** The system centralizes and manages compliance with industry standards like ISO, D FAR's, and AS-90100D, proving invaluable in dynamic regulatory environments and significantly reducing audit concerns for companies in highly regulated industries. * **Enhanced Cross-Functional Communication:** EQMS provides real-time access to quality and manufacturing data, fostering a "single source of the truth" across the enterprise, especially when integrated with ERP systems, which improves decision-making and consistency. * **Consistent Inspection Processes:** It ensures that inspectors always have access to the latest approved criteria for incoming material and in-process inspections electronically, preventing errors associated with outdated paper records. * **Effective Nonconformity and Corrective Action Management:** Failed inspection criteria can be immediately recorded as nonconformities, leading to material holds. The system then electronically tracks corrective actions, complete with detailed task plans, ensuring all necessary steps are completed before closure. * **Robust Traceability and Genealogy:** EQMS offers the power and flexibility to create, record, query, and manage traceability requirements, maintaining a complete genealogy of every part, sub-assembly, and final assembly, which is critical for compliance and quality investigations. * **Controlled Document Management:** The system ensures that only the latest approved documentation is always available through robust document revision control. It also facilitates scheduled periodic reviews and manages approval groups for individual assignments, maintaining document integrity. * **Improved Supply Chain Visibility:** EQMS enhances transparency by tracking key performance indicators (KPIs) such as delivery, cost, and compliance for suppliers. This visibility helps identify areas needing attention, promotes continuous improvement, and quantifies the real cost of supplier failures. * **Measurement Tool Calibration Management:** Records are maintained on specific measurement tools used in assembly steps and product components. If a tool is found to be out of calibration, the system allows for easy review of all associated measurements to assess impact and implement quality improvements. * **Comprehensive Employee Training Tracking:** For highly regulated industries, EQMS effectively tracks employee training requirements related to manufacturing processes or regulatory compliance. It sends reminders for expiration dates and can restrict employees with expired training from performing tasks, ensuring a properly educated workforce and higher quality end products. * **Operational Excellence and Efficiency:** Implementing an EQMS enables best practices in quality management, ensuring operational excellence throughout the product lifecycle. It helps companies meet quality and compliance challenges while simultaneously increasing manufacturing efficiencies. Tools/Resources Mentioned: * **TIPQA:** TIP Technologies' quality management solution, highlighted as a leader in the field. * **ERP (Enterprise Resource Planning):** Mentioned as a system that can integrate with EQMS to create a "single source of the truth." Key Concepts: * **Electronic Quality Management System (EQMS):** A computer-based system designed to manage and automate quality processes, documentation, and compliance within an organization. * **Regulatory Compliance:** Adherence to industry standards and government regulations (e.g., ISO, D FAR's, AS-90100D, and implicitly GxP, FDA, EMA for highly regulated industries). * **Product Lifecycle Management:** The process of managing the entire lifecycle of a product from inception, through engineering design and manufacture, to service and disposal. * **Nonconformity:** A deviation from a specification, standard, or expectation. * **Corrective Actions:** Actions taken to eliminate the cause of a detected nonconformity or other undesirable situation to prevent recurrence (often part of a CAPA process). * **Traceability:** The ability to track the history, application, or location of an item or activity by means of recorded identification. * **Document Revision Control:** A system for managing changes to documents, ensuring that only the latest approved versions are in use and accessible. * **Supplier Performance Management:** The process of measuring, analyzing, and managing the performance of suppliers to control costs, mitigate risks, and drive continuous improvement. * **Calibration Management:** The process of ensuring that measurement tools and equipment are accurate and functioning correctly according to established standards. * **Employee Training Management:** The system for tracking, managing, and ensuring that employees have the necessary skills and certifications for their roles, especially in regulated environments.
Industry Update: Zinc to Vault PromoMats
NetworkPharma
/@networkpharmatv
Jul 6, 2018
This video provides an in-depth industry update on the migration from Zinc to Veeva Vault PromoMats, presented by Stacy Hardie, Associate Director, Content Partners at Veeva Europe. The primary purpose of the presentation is to inform Veeva's mutual customers and agency partners about the progress, benefits, and support mechanisms related to this significant platform transition within the life sciences industry. The speaker outlines the strategic context of Veeva's product suite, the enhanced capabilities of Vault PromoMats, and the critical role of agencies in ensuring a smooth and successful migration for pharmaceutical companies. The presentation begins by establishing the background of Veeva's acquisition of Zinc in 2015 and the subsequent plan to transition existing Zinc MAPS customers to Vault PromoMats. Hardie notes that by 2018, 50% of Zinc customers had either migrated or committed to the transition, with the Zinc product slated for discontinuation at the end of 2020. This timeline underscores the urgency for agencies and pharma companies, particularly in key markets like the UK, to understand the new product and prepare for the change. The discussion then broadens to position Vault PromoMats within Veeva's extensive cloud-based ecosystem, which spans the entire life sciences value chain from R&D through medical affairs to commercial operations. Vault PromoMats and Vault MedComms are highlighted as the key applications impacting medical communications, designed to streamline content creation, review, and distribution while ensuring compliance. A significant portion of the update focuses on the advanced features and strategic advantages of Vault PromoMats over its predecessor, Zinc. Hardie explains how PromoMats completes the "digital supply chain" by integrating medical, legal, and regulatory (MLR) approval processes with automated content distribution and withdrawal, thereby providing complete visibility and control over commercial and medical materials. Key enhancements include a deeper audit trail, configurable verdicts for reviews (eliminating "forgotten stamps"), a multi-purpose annotation tool with automatic text/image detection and revision text capabilities, and anchoring for references to facilitate easier and more accurate content reuse. The speaker emphasizes the importance of source content support in PromoMats, enabling customers to drive content efficiencies, promote reuse across geographies, and gain insights into content leverage. The video concludes by detailing Veeva's comprehensive support for agencies, including a dedicated certification program, a 24/7 Global Service Center, and various community resources, underscoring the collaborative effort required for a successful industry-wide transformation. Key Takeaways: * **Mandatory Migration Timeline:** The Zinc product was scheduled for discontinuation at the end of 2020, necessitating all existing Zinc MAPS customers to migrate to Veeva Vault PromoMats. Agencies and pharmaceutical companies needed to be aware of this deadline and plan accordingly. * **Veeva's Integrated Life Sciences Ecosystem:** Veeva offers a comprehensive suite of cloud-based products that span the entire life sciences company, from R&D to medical and commercial operations. Vault PromoMats and Vault MedComms are integral parts of this ecosystem, specifically targeting content management and medical communications. * **Vault PromoMats as a Holistic Solution:** Vault PromoMats is presented as a life sciences-specific application that combines content creation, review, and distribution capabilities with integrated digital asset management (DAM). It ensures compliance, manages referencing and claims, and serves as a global repository for storing and sharing approved digital assets. * **Completing the Digital Supply Chain:** Unlike disconnected legacy systems where review and distribution occurred in separate platforms, Vault PromoMats completes the digital supply chain. It integrates MLR approval processes with automated content distribution and withdrawal, providing end-to-end visibility and control over commercial and medical materials. * **Enhanced Compliance and Auditability:** Vault PromoMats offers a deeper and clearer audit trail compared to Zinc. It features configurable verdicts for review tasks, ensuring compliance by requiring explicit actions to complete reviews and preventing "forgotten stamps" or missed approvals. * **Streamlined Review and Annotation Tools:** The platform includes a multi-purpose annotation tool that automatically detects text versus images and offers a revision text tool to copy selected text directly into comment boxes. This significantly simplifies the review process for agencies and internal teams. * **Improved Referencing and Content Reuse:** PromoMats supports anchoring for references, allowing specific sections within a reference document to be linked, which enhances accuracy and ease of content reuse. The ability to upload source content directly to PromoMats is a key differentiator, driving content efficiencies and promoting sharing across geographies while maintaining data chain of custody. * **Critical Role of Agencies in Digital Transformation:** Agencies are identified as crucial partners in the migration process, responsible for uploading content, completing referencing, and incorporating reviewer feedback. Their proficiency with Vault PromoMats is essential for the success of their clients' digital transformation initiatives. * **Veeva's Agency Certification Program:** To support agencies, Veeva launched a certification program comprising over 50 interactive training modules, an exam simulation, and a certification database. This program aims to ensure agencies possess the necessary knowledge and competencies with the product. * **Comprehensive Support Resources:** Veeva provides extensive support, including a 24/7 Global Service Center for technical assistance, LinkedIn community groups (Promotional Compliance Group, DAM Life Sciences Community), a dedicated Zinc Migrations Tab on Vault Online Help, and the Vault PromoMats Innovation Hub with webinars on best practices and new features. **Tools/Resources Mentioned:** * **Veeva Vault PromoMats:** The primary content management and promotional materials approval platform. * **Veeva Vault MedComms:** A related Veeva product for medical communications content. * **Zinc MAPS:** The legacy content management software being migrated away from. * **Veeva's LMS System:** The learning management system used for the agency certification program's training modules. * **Veeva Global Service Center:** Provides 24/7 technical support for Veeva products. * **LinkedIn Groups:** * Promotional Compliance Group * DAM Life Sciences Community * **Vault Online Help:** Specifically, the "Zinc Migrations Tab" for transition guides, terminology glossaries, and how-to videos. * **Vault PromoMats Innovation Hub:** A resource on Veeva.com offering webinars on best practices, product features, and capabilities. * **Veeva.com/agencies:** A web page dedicated to agency support, including details on the multi-channel partner program and the Vault PromoMats certification program. **Key Concepts:** * **Digital Supply Chain:** The integrated process of content creation, review, approval, distribution, and withdrawal within a single, connected system, ensuring complete visibility and control. * **Digital Asset Management (DAM):** Capabilities within Vault PromoMats for storing, tagging, and sharing approved digital assets globally across an organization. * **Medical Legal Regulatory (MLR) Approval:** The critical process of reviewing and approving marketing, educational, and communication materials to ensure compliance with industry regulations. * **Content Reuse:** The strategy of leveraging existing approved content across different geographies, channels, or campaigns to improve efficiency and consistency, facilitated by features like source content support and anchoring for references. * **Configurable Verdicts:** A feature in Vault PromoMats that requires explicit actions or choices during a review task, ensuring that reviewers provide clear outcomes and preventing accidental or incomplete approvals. * **Anchoring for Referencing:** The ability to link specific sections within a reference document to claims in promotional materials, enhancing accuracy and ease of verification.
Trial Master File (TMF) for Sponsors: Set-Up and Maintenance Trailer
Kathy Barnett
/@kathybarnett4070
Jun 21, 2018
This video provides an in-depth exploration of the Trial Master File (TMF) for sponsors, focusing on its critical role in clinical trial management, setup, maintenance, and regulatory compliance. The speaker, a trainer working with Barnett and Associates, emphasizes the TMF as the comprehensive "story" of a clinical study, documenting every aspect from its inception to its archiving. This narrative approach helps clarify what content belongs in the TMF, asserting that any document contributing to the study's story is relevant. The session is positioned as a foundational class, addressing the evolving regulatory landscape and its impact on essential documentation practices for sponsor trials. The presentation delves into the components of the TMF, offering recommendations for TMF policies and management strategies. A significant portion is dedicated to the practical aspects of maintaining and performing quality control (QC) on the TMF. A core principle reiterated throughout is, "If it didn't get documented, it did not happen," highlighting the TMF's function as irrefutable evidence for health authorities during inspections. The speaker explains that inspectors primarily assess the documentation within the TMF to evaluate trial conduct, confirm data integrity, and ensure compliance with Good Clinical Practice (GCP). The video also discusses common deficiencies and challenges encountered in TMF management and introduces the TMF Reference Model as a key organizational tool. A crucial insight from the speaker is the assertion that TMF content generation is a cross-functional responsibility, not solely confined to clinical operations. The speaker challenges the misconception that only clinical teams contribute to the TMF, arguing that every functional area involved in a study – including medical affairs, regulatory affairs, safety, biosciences, data sciences, vendor management, and even finance – generates "chapters" of the study's story that must be part of the TMF. This holistic view underscores that if a department contributes to the study, it contributes to the TMF. The video also clarifies the definition of "essential documents," noting their evolution beyond the initial scope outlined in ICH GCP Section 8.1, and reiterates that the TMF serves as the "articles of inspection" for regulatory bodies. Key Takeaways: * **TMF as the "Story" of the Study:** The Trial Master File should be conceptualized as the complete narrative of a clinical trial, beginning from its start and concluding with its archive. This perspective simplifies decisions on what content to include, as anything contributing to the study's story belongs in the TMF. * **Regulatory Imperative: Documentation is Evidence:** A fundamental principle in clinical research is "If it didn't get documented, it did not happen." The TMF serves as the primary evidence for health authorities (e.g., FDA, EMA) to verify that a sponsor fulfilled its obligations and conducted the trial as planned. * **TMF is the Focus of Inspections:** Health authority inspections are predominantly an assessment of the TMF. Inspectors review the documentation to evaluate trial conduct, confirm data integrity, and ensure compliance with Good Clinical Practice (GCP), making the TMF the "articles of inspection." * **Cross-Functional Responsibility:** TMF content generation is not limited to clinical operations. All functional areas contributing to a study – including medical affairs, regulatory affairs, safety, biosciences, data sciences, vendor management, and finance – are responsible for generating and contributing relevant documentation to the TMF. * **Evolving Definition of Essential Documents:** While ICH GCP Section 8.1 provides a foundational list, the concept of "essential documents" has evolved. Anything that contributes to the comprehensive story of the trial, beyond the initial list, is considered essential for the TMF. * **Importance of TMF Policy and Management:** Establishing clear policies and robust management strategies for TMF setup, maintenance, and archiving is crucial for ensuring its completeness, accuracy, and accessibility, which are vital for regulatory compliance. * **Continuous Quality Control and Assurance:** Ongoing quality control (QC) and quality assurance (QA) activities are indispensable for the TMF. These processes help identify and rectify deficiencies, ensuring the TMF remains inspection-ready and accurately reflects the trial's conduct. * **Utilizing the TMF Reference Model:** The TMF Reference Model is a valuable tool for organizing and standardizing TMF content. Its discussion in the seminar highlights its utility in overcoming common organizational challenges and promoting consistency across trials. * **Ensuring Data Integrity and GCP Compliance:** The ultimate purpose of the TMF is to enable the evaluation of the trial's conduct, confirm the integrity of the data collected, and demonstrate compliance with GCP, which are non-negotiable aspects of clinical research. * **Addressing Common Deficiencies:** The seminar discusses common deficiencies and challenges in TMF management, providing insights into pitfalls to avoid and best practices for maintaining a compliant and comprehensive TMF. Key Concepts: * **Trial Master File (TMF):** A collection of essential documents that individually and collectively permit the evaluation of the conduct of a clinical trial and the quality of the data produced, and demonstrate compliance with GCP. * **Essential Documents:** Documents that allow for the evaluation of the conduct of the trial, the quality of the data, and demonstrate compliance with GCP. Their scope extends beyond the initial ICH GCP 8.1 list to include anything relevant to the trial's "story." * **Sponsor Obligations:** The responsibilities of the organization (e.g., pharmaceutical company, CRO) initiating, managing, and/or financing a clinical trial, particularly concerning documentation and regulatory compliance. * **ICH GCP Section 8.1:** A specific section within the International Conference on Harmonisation's Guideline for Good Clinical Practice that defines essential documents for the conduct of a clinical trial. * **TMF Reference Model:** An industry-standard, universally accepted taxonomy and hierarchy for TMF documents, designed to facilitate consistent organization and management of TMF content. * **Quality Control (QC) and Quality Assurance (QA):** Systematic processes to ensure that the TMF meets predefined quality standards, is complete, accurate, and compliant with regulatory requirements. * **Health Authority Inspections:** Audits conducted by regulatory bodies (e.g., FDA, EMA) to assess the conduct of clinical trials and ensure compliance with applicable regulations and guidelines. * **Code of Federal Regulations (CFR) and EU Directives:** Legal frameworks and guidelines that govern clinical research and documentation practices in the United States and the European Union, respectively.
Mango - Quality Management System
Mango
/@Mangolive
May 21, 2018
This video provides an in-depth exploration of Mango, a Quality Management System (QMS) software designed to alleviate the administrative burdens and complexities associated with maintaining a robust quality system. The presenter begins by likening running a good QMS to being a "skilled juggler," highlighting the myriad tasks involved, such as conducting audits, updating policies, tracking training records, managing non-conformances and corrective actions, maintaining equipment, evaluating suppliers, and holding management reviews. The core problem identified is the pain of manual administration, including excessive paperwork, spreadsheets, and double-handling, which often leads to falling behind or forgetting critical tasks. Mango is introduced as a comprehensive solution built by former quality managers and auditors who understand these challenges firsthand. The video details how Mango addresses these issues by modularizing all aspects of a QMS, such as improvements, audits, and training. These modules seamlessly interact and share information in the background, presenting users with an easy-to-use interface. Mango's two key functionalities are providing real-time status updates of the entire system and automatically notifying users when tasks need to be completed. This ensures users always have the most up-to-date information, from employee qualifications to current document versions, and are prompted for actions like audits, training renewals, calibrations, and supplier evaluations, eliminating the need for manual tracking. A guided tour of Mango's dashboard and various modules illustrates its capabilities. The dashboard offers high-level, instant, and accurate information, such as the number of open or closed improvements across business areas. The "Events" module acts as the system's "beating heart," reminding users of due tasks like internal audits or equipment recalibrations, and escalating alerts to management if tasks are consistently missed. The "Compliance" module is crucial for meeting regulatory obligations, including legislation, regulations, and international standards like ISO 9001, 14001, 22000, and 45001. It allows for easy configuration, recording, and control of compliance issues, linking verifiable evidence to requirements, automatically creating legal registers, and identifying compliance gaps for action planning. Other modules include "Improvement" (managing non-conformances, CAPA, customer complaints, deviations), "Audit/Inspection" (automated checklists, direct integration with improvement module, automatic report generation), "Documents" (centralized, version-controlled, electronic signatures, automatic archiving), "Human Resources" (managing employee skills, training, competencies, qualifications, and skills matrices), "Plant and Equipment Maintenance," and "Suppliers and Contractors" (tracking evaluations and non-conformances). The video concludes by emphasizing Mango's benefits: greater transparency, freedom from repetitive tasks, increased efficiency, and the ability for quality managers to focus on business improvement. Key Takeaways: * **Addressing QMS Administrative Burden:** Running a Quality Management System (QMS) is often a complex, administrative-heavy task involving juggling numerous elements like audits, policies, training, non-conformances, and equipment maintenance. Mango aims to eliminate the pain points of manual tracking, spreadsheets, and double-handling. * **Real-time System Status:** Mango provides instant, accurate, and real-time visibility into the entire QMS. This means users can quickly ascertain information such as qualified employees for specific tasks, current document versions, or the status of non-conformances without sifting through multiple files or spreadsheets. * **Automated Reminders and Notifications:** The system automatically notifies users when tasks are due, covering everything from audits and training renewals to equipment calibrations and supplier evaluations. This proactive alert system helps prevent oversight and ensures timely completion of critical QMS activities. * **Modular and Integrated Design:** Mango's QMS is built on interconnected modules (e.g., improvements, audits, training, compliance, documents, HR). These modules seamlessly share information, eliminating the need for redundant data entry and ensuring consistency across the system. * **Comprehensive Compliance Management:** The "Compliance" module allows organizations to manage adherence to various obligations, including national legislation, industry regulations, and international standards like ISO 9001, 14001, 22000, and 45001. It helps create legal registers, identify compliance gaps, and link verifiable evidence to demonstrate conformity to authorities. * **Streamlined Improvement Processes:** The "Improvement" module centralizes the management of critical quality issues such as customer complaints, non-conformances, corrective actions (CA), preventive actions (PA), audit findings, document change requests, and deviations, making them visible and actionable for all relevant stakeholders. * **Automated Audit Workflow:** The "Audit/Inspection" module simplifies the auditing process by providing automated email reminders for due audits, digital checklists for recording findings (including photos/videos), and direct integration with the improvement module to automatically create non-conformances. It also automatically generates audit reports upon sign-off. * **Centralized Document Control:** The "Documents" module ensures everyone works from the most current version of policies, procedures, forms, and checklists. It features an electronic signature process for editing, approving, and publishing, with automatic archiving of old versions and controlled access to ensure document integrity. * **Integrated Human Resources Management:** The "Human Resources" module centralizes all employee-related QMS information, including training records, competency records, certificates, performance appraisals, and qualifications. It also facilitates the easy creation of skills matrices, ensuring that only authorized personnel can access sensitive HR data. * **Enhanced Efficiency and Focus:** By automating routine administrative tasks, Mango frees up quality managers from repetitive jobs, allowing them to dedicate more time to strategic business improvement initiatives. This also makes external audits significantly easier and provides CEOs with instant insights into the QMS's overall health. **Tools/Resources Mentioned:** * **Mango:** A Quality Management System (QMS) software. **Key Concepts:** * **Quality Management System (QMS):** A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. * **Non-conformance:** A deviation from a specification, standard, or expectation. * **Corrective Action Preventive Action (CAPA):** A system for investigating and correcting identified non-conformances (corrective action) and preventing potential non-conformances (preventive action). * **ISO Standards:** International Organization for Standardization standards, such as ISO 9001 (Quality Management), ISO 14001 (Environmental Management), ISO 22000 (Food Safety Management), and ISO 45001 (Occupational Health and Safety Management). * **Legal Register:** A document that lists all legal and other requirements applicable to an organization's operations, products, or services. * **Skills Matrix:** A visual tool used to map required and actual skills for a team or organization, often used for training and development planning.
What is a Trial Master File (TMF) Specialist?
Elite Clinical Research
/@EliteClinicalResearch
May 17, 2018
This video explores the critical role of a Trial Master File (TMF) Specialist within clinical research. The speaker highlights a pervasive industry challenge: TMFs are frequently in "bad shape," leading to significant financial and operational burdens for sponsors at the end of a study. The TMF Specialist position has emerged to address this by serving as a dedicated point person responsible for ensuring the completeness, accuracy, and up-to-dateness of the TMF throughout the trial. This proactive management aims to mitigate the stress and costs associated with last-minute reconciliation, emphasizing the TMF's status as the "most important deliverable" to the sponsor. The role involves extensive document handling, auditing, quality assessment, and ensuring compliance with sponsor requirements, thereby streamlining clinical operations and supporting regulatory readiness. Key Takeaways: * **Widespread TMF Challenges:** The clinical research industry faces a significant problem with poorly maintained Trial Master Files, leading to substantial costs, delays, and stress for sponsors at the conclusion of studies. * **Strategic Importance of TMF:** The TMF is identified as the "most important deliverable" to sponsors, underscoring its critical role in regulatory compliance, audit readiness, and overall study integrity. * **Shift to Proactive Management:** The emergence of the TMF Specialist role signifies an industry shift towards continuous, proactive management of TMFs throughout the clinical trial lifecycle, moving away from reactive reconciliation at study close-out. * **Comprehensive TMF Oversight:** TMF Specialists are responsible for monitoring the health of the TMF, ensuring all essential documents are collected, correctly filed, named, signed, and complete, and aligning with sponsor and regulatory requirements. * **Operational Pain Points:** The video implicitly points to opportunities for process improvement, such as the challenge of monitors not prioritizing TMF document submission and high staff turnover, which complicate document collection and maintenance.