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Quality Digest LIVE, December 8, 2017
Quality Digest
/@QualityDigest
Dec 8, 2017
This episode of Quality Digest Live, from December 8, 2017, provides an in-depth exploration of several critical topics relevant to quality management, manufacturing trends, and organizational efficiency. The hosts, Mike Richman and Dr. Sean, discuss the evolving landscape of smart manufacturing technologies, the importance of quality management systems (QMS), and the broader societal implications of automation. The broadcast serves as a snapshot of industry concerns and technological advancements from that period, emphasizing the need for adaptable systems and proactive management in an increasingly automated world. The discussion begins by highlighting key smart manufacturing trends, including the growing adoption of cobots, advancements in production 3D printing, and the pervasive influence of the Industrial Internet of Things (IIoT). Smart manufacturing is defined as making all manufacturing process information available precisely when, where, and in the form it is needed across the entire supply chain, largely driven by digital technologies. The hosts elaborate on the rapid growth of augmented reality (AR) in manufacturing and field operations, enabling workers to access critical information and live assistance directly in their line of sight. This segment underscores the transformative potential of these technologies in enhancing productivity and operational intelligence. A significant portion of the video is dedicated to the essential elements of a robust Quality Management System, drawing insights from an article by Tim Lozier of ETQ. The discussion centers on a "tools-based approach" to QMS, identifying five crucial needs: flexibility, traceability, risk-based thinking, integration, and reporting. Each element is explored in detail, emphasizing how modern QMS software should be configurable to an organization's specific needs, ensure seamless data flow across departments, incorporate human-analyzed risk assessments, break down operational silos, and provide actionable insights from vast amounts of data. The hosts also touch upon the evolution of QMS software in parallel with ISO 9001 standards, moving from simple checklists to sophisticated process and risk-based approaches. The broadcast concludes with a thought-provoking debate on the net impact of automation on jobs, considering historical precedents and the need for workforce retraining. Key Takeaways: * **Defining Smart Manufacturing:** Smart manufacturing leverages digital technologies to ensure all process information is available precisely when, where, and in the required format across the entire manufacturing supply chain, optimizing decision-making and operations. * **Emerging Manufacturing Technologies:** Key drivers of smart manufacturing in 2017 included collaborative robots (cobots), advanced 3D printing, and the Industrial Internet of Things (IIoT), all contributing to increased automation and efficiency. * **Impact of Augmented Reality (AR):** AR was identified as a rapidly growing technology, proving highly useful in manufacturing and field work by providing immediate, in-context access to documents, work instructions, or live expert assistance directly to the user's view. * **QMS Flexibility and Configurability:** A superior Quality Management System (QMS) should be flexible and configurable, allowing organizations to adapt the software tools to their specific processes, forms, and reporting needs, rather than forcing the organization to conform to the software. * **Importance of QMS Traceability:** Effective QMS requires robust traceability, ensuring seamless data flow and connection across disparate sections of the enterprise. This prevents redundant data entry (e.g., customer complaints) and maintains data integrity throughout the operational lifecycle. * **Risk-Based Thinking in QMS:** Incorporating risk-based thinking, aligned with standards like ISO 9001:2015, is crucial. While tools can automate risk evaluation (e.g., FMEA, RPN), human interaction is essential to analyze the meaning of those risks and determine appropriate mitigation strategies (accept, reduce, compensate, transfer, or avoid). * **QMS Integration for Quality:** Silos are detrimental to quality. Integrating various functional areas of the enterprise through the QMS enhances overall visibility, accelerates issue identification, and fosters increased collaboration across teams. * **Actionable QMS Reporting:** A robust QMS generates significant data. The ability to effectively analyze this data and extract critical, actionable insights is vital for continuous improvement and for moving the needle on organizational performance, distinguishing effective QMS from merely compliant ones. * **Evolution of QMS Software:** The development of QMS software has mirrored the evolution of quality standards like ISO 9001, transitioning from simple checklist-based systems to more sophisticated platforms that support process-oriented and risk-based approaches, offering greater flexibility for diverse industries. * **Stakeholder Engagement in Standards Development:** The discussion on the ANSI standard for remanufacturing highlights the critical role of stakeholder feedback in shaping international standards. Organizations are encouraged to participate in comment periods to ensure standards reflect their operational realities and interests. * **Automation's Impact on Employment:** The video delves into the debate surrounding job displacement versus job creation due to automation. While some predict net job losses, the hosts suggest a shift towards higher-value jobs requiring advanced skills, emphasizing the need for continuous education and STEM training to prepare the workforce for future roles. **Tools/Resources Mentioned:** * **ETQ:** A company specializing in quality management software, whose insights are featured regarding QMS needs. * **Mitutoyo Corporation:** A sponsor mentioned as a provider of measurement and inspection solutions, including CMMs, sensors, and metrology data management software. * **Quality Digest:** The host publication and channel, providing resources and commentary on quality management. * **ANSI (American National Standards Institute):** An organization involved in the development and oversight of standards, mentioned in the context of a new remanufacturing standard proposal. * **ISO 9001:2015:** An international standard for quality management systems, specifically referenced for its emphasis on risk-based thinking. **Key Concepts:** * **Smart Manufacturing:** An umbrella term for manufacturing that is highly digitalized and connected, leveraging information across the supply chain for optimal decision-making. * **Augmented Reality (AR):** A technology that overlays digital information onto the real world, enhancing human perception and interaction, particularly useful for instructions and remote assistance in industrial settings. * **Quality Management System (QMS):** A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives, often supported by software tools. * **Risk-Based Thinking:** A core principle in modern quality management, requiring organizations to identify, assess, and address risks and opportunities to ensure the QMS achieves its intended results. * **Traceability:** The ability to track and verify the history, location, or application of an item or activity by means of recorded identification, crucial for quality control and regulatory compliance. * **Integration:** The process of combining different systems, processes, or data sources to work together seamlessly, eliminating silos and improving overall operational visibility and efficiency. * **Configurability:** The ability of a software system to be customized or adapted to specific user requirements without requiring changes to its core code, offering flexibility to diverse organizational needs.
The IDMP countdown starts now: OMS / RMS onboarding will begin on the 15th December this year!
EXTEDO
/@EXTEDOpulse
Dec 6, 2017
This video provides an update on the European Medicines Agency's (EMA) Identification of Medicinal Products (IDMP) implementation, specifically focusing on the SPOR (Substances, Products, Organizations, and Referentials) master data services. Anjana Pindoria, a member of EU telematics workgroups for eCTD, xEVMPD, and IDMP, recaps the October task force meeting, highlighting significant shifts and upcoming deadlines for the pharmaceutical industry. The core message emphasizes the transition towards a more value-based approach for IDMP, moving beyond its initial focus on pharmacovigilance, and the imminent operationalization of key regulatory data management components. The speaker details three primary achievements and developments. Firstly, the IDMP scope has broadened from solely pharmacovigilance and patient safety to encompass a more value-based approach, fostering collaboration between National Competent Authorities (NCAs) and industry to create a more efficient and intelligent regulatory landscape. This signifies a move towards streamlining review submissions and approvals. Secondly, the Organization Management Service (OMS) and Referential Management Service (RMS) are now live, requiring companies to register their "super users" in December. This is a critical step for industry engagement with the new data management systems. Thirdly, the electronic application form is undergoing a significant update, with OMS data being integrated into all four forms by December, initially for optional use, but with a strong recommendation from the EMA for early familiarization. A significant portion of the discussion is dedicated to the concept of "controlled vocabularies," which is fundamental to the successful implementation of IDMP, OMS, and RMS. Pindoria uses a relatable anecdote about ordering a salad with "aubergine" (eggplant in American English) to illustrate the critical importance of speaking a "same language" in data exchange. She explains that controlled vocabularies are predefined terms that ensure consistency, structure, and efficiency in data management. By adopting these standardized terms, the industry can achieve greater organization and efficiency in regulatory submissions and data handling, ultimately preparing for when these systems become mandatory and ensuring seamless communication across the regulatory ecosystem. Key Takeaways: * **IDMP Scope Expansion:** The IDMP initiative has evolved beyond its initial focus on pharmacovigilance and patient safety to embrace a broader, value-based approach, aiming for a more efficient and intelligent regulatory landscape through joint collaboration between National Competent Authorities (NCAs) and the industry. * **Operationalization of OMS/RMS:** The Organization Management Service (OMS) and Referential Management Service (RMS) are now live, marking a critical phase in the EMA's SPOR master data services implementation. Companies must prepare for their operational use. * **Super User Registration Deadline:** A key immediate action item for pharmaceutical companies is the registration of "super users" for OMS and RMS in December. This is essential for accessing and interacting with the new systems. * **Guidance for Onboarding:** The EMA has provided resources, including dedicated YouTube channels and social media sites, offering step-by-step guidance on how to register super users and understand the workflow with controlled vocabularies. * **Electronic Application Form Integration:** The electronic application forms are being updated to integrate OMS data across all four forms by December. While initially optional, the EMA strongly encourages early adoption and familiarization. * **Proactive Familiarization is Key:** Industry stakeholders are urged to start performing searches, using the available OMS data, and familiarizing themselves with the new forms and data structures now. This proactive approach will ensure preparedness when the use of OMS data eventually becomes mandatory. * **Importance of Controlled Vocabularies:** A central theme is the necessity of "controlled vocabularies"—predefined, standardized terms that ensure everyone "speaks the same language" in regulatory data. This standardization is crucial for structured, organized, and efficient data exchange. * **Benefits of Standardized Language:** Adopting controlled vocabularies leads to increased organization, efficiency, and clarity in regulatory submissions and data management, reducing ambiguity and errors inherent in disparate terminology. * **Future Preparedness:** Early engagement with OMS, RMS, and controlled vocabularies will position companies as "experienced experts" when these systems become mandatory, streamlining future compliance and operational processes. Tools/Resources Mentioned: * EMA social media sites * EMA's dedicated YouTube channels (specifically for OMS/RMS guidance) Key Concepts: * **IDMP (Identification of Medicinal Products):** A set of ISO standards for the unique identification of medicinal products, crucial for global pharmacovigilance and regulatory activities. * **SPOR (Substances, Products, Organizations, and Referentials):** The EMA's master data services, which include OMS and RMS, designed to support IDMP implementation and provide centralized, authoritative data. * **OMS (Organization Management Service):** An EMA service providing master data on organizations (e.g., marketing authorization holders, manufacturers) involved in regulatory procedures. * **RMS (Referential Management Service):** An EMA service providing master data on referentials (e.g., lists of countries, routes of administration, dosage forms) used in regulatory submissions. * **Controlled Vocabularies:** Predefined, standardized sets of terms used to ensure consistency and interoperability in data exchange, critical for structured data management in regulatory contexts. * **NCA (National Competent Authorities):** The regulatory bodies within individual EU member states responsible for overseeing medicinal products.
EXTEDO eCTDmanager Customer Interview: Glenn Robertson, Puma Biotechnology
EXTEDO
/@EXTEDOpulse
Nov 21, 2017
This video features Glenn Robertson, Head of Regulatory Operations at Puma Biotechnology, discussing his company's positive experience with EXTEDO's eCTDmanager software. Puma Biotechnology, a pharmaceutical company focused on developing a breast cancer drug, faced the critical challenge of simultaneously preparing and submitting both New Drug Application (NDA) and Marketing Authorization Application (MAA) dossiers. Robertson details how eCTDmanager provided an effective solution, enabling his team to develop both complex applications concurrently within the tool, which significantly enhanced efficiency and reduced the time required for these essential regulatory submissions. Robertson highlights the invaluable "open sequences" or "parallel sequences" feature of the software. This functionality allowed his team to work on multiple submission sequences simultaneously without interrupting progress on larger, ongoing submissions. This capability meant they could efficiently manage smaller, incremental submissions while keeping the primary NDA/MAA dossiers open, thereby streamlining their workflow and preventing bottlenecks. The adoption of eCTDmanager also facilitated a strategic shift for Puma Biotechnology, allowing them to transition from outsourcing their regulatory submission activities to managing them entirely in-house, which provided greater control and operational efficiency. The interview underscores the tangible return on investment achieved through the software, primarily measured in substantial time savings. Robertson specifically mentions a reduction in the initial application preparation time from an estimated eight weeks down to just three weeks. Furthermore, smaller, routine submissions that previously took a full day could now be completed in a matter of hours. These efficiency gains were crucial for accelerating market access for their cancer drug. Robertson also emphasizes the critical role of the partnership with EXTEDO, noting their willingness to provide on-site support during crucial submission periods, which ensured prompt resolution of any technical issues and directly contributed to Puma Biotechnology's overall success in their regulatory endeavors. Key Takeaways: * **Streamlined Parallel Regulatory Submissions:** Puma Biotechnology successfully managed the simultaneous preparation of complex NDA and MAA applications using eCTDmanager, demonstrating the software's capability to handle concurrent, high-stakes regulatory dossiers efficiently for global market entry. * **Significant Time and Cost Savings:** The implementation of eCTDmanager led to a dramatic reduction in submission timelines, cutting initial application preparation from eight weeks to three weeks and smaller submissions from a full day to mere hours, directly impacting operational costs and time-to-market. * **Optimized Workflow with Parallel Sequencing:** The "open sequences" feature was instrumental, allowing the regulatory team to work on multiple submission sequences concurrently. This capability enabled the efficient management of smaller, urgent submissions without disrupting progress on larger, ongoing dossiers, thereby preventing delays and improving overall productivity. * **Transition to In-house Regulatory Operations:** The software empowered Puma Biotechnology to bring its regulatory submission processes in-house, moving away from outsourcing. This strategic shift offers greater control over critical data, fosters internal expertise, and can lead to long-term cost efficiencies. * **Tangible ROI Measured in Time:** The primary metric for return on investment identified was significant time savings in regulatory processes. This highlights that for pharmaceutical companies, accelerating submission and approval cycles directly translates to business value, impacting revenue generation and patient access. * **Critical Role of Vendor Partnership and Support:** The success was partly attributed to a close partnership with EXTEDO, including on-site support during critical submission phases. This emphasizes the importance of responsive and dedicated vendor assistance for complex, high-stakes regulatory activities. * **Accelerating Oncology Drug Development:** The context of developing a breast cancer drug underscores the urgency and high stakes involved. Efficient regulatory processes are not just about compliance but also about expediting the availability of life-saving therapies to patients. * **Regulatory Compliance as a Strategic Imperative:** The video reinforces that managing complex regulatory applications like NDA and MAA is a core strategic function that requires specialized tools and expertise, directly influencing a pharmaceutical company's ability to commercialize its products. * **Impact on Commercialization Timelines:** While not explicitly detailed, the efficiency gains in regulatory submissions directly contribute to faster market approval and launch timelines, which are critical factors for a pharmaceutical company's commercial success and revenue generation. Tools/Resources Mentioned: * **EXTEDO eCTDmanager:** A specialized software solution designed for the creation, management, and submission of Electronic Common Technical Documents (eCTD) to regulatory authorities worldwide. Key Concepts: * **NDA (New Drug Application):** A comprehensive application submitted to the U.S. Food and Drug Administration (FDA) seeking approval to market a new pharmaceutical drug in the United States. * **MAA (Marketing Authorization Application):** A similar comprehensive application submitted to the European Medicines Agency (EMA) or national regulatory bodies in Europe to gain approval for marketing a new drug within the European Union/EEA. * **eCTD (Electronic Common Technical Document):** An internationally agreed-upon format for organizing and submitting regulatory applications electronically, ensuring a standardized structure for drug dossiers across various global regulatory agencies. * **Open Sequences / Parallel Sequences:** A feature within eCTD management software that allows users to simultaneously work on and manage multiple distinct submission sequences. This enables efficient handling of both large, ongoing applications and smaller, concurrent updates or new submissions without data loss or workflow interruption. Examples/Case Studies: * **Puma Biotechnology's Dual Submission Challenge:** The central case study involves Puma Biotechnology's successful simultaneous preparation and submission of NDA and MAA for their breast cancer drug, demonstrating the practical application and benefits of eCTDmanager in a high-pressure regulatory environment. * **Quantifiable Time Savings:** Specific examples of efficiency gains include the reduction of initial application preparation from an estimated eight weeks to three weeks, and the completion of smaller, routine submissions in hours instead of a full day.
Consulting: Electronic Quality Management System Implementation. Selection Process
Gary Ugarek (GeForce Quality Solutions)
/@garyugarek7489
Nov 15, 2017
This video directly addresses the selection and implementation of Electronic Quality Management Systems (eQMS) within FDA-regulated industries, specifically pharmaceuticals, biotech, and medical devices. Key Takeaways: * **Criticality of End-User Involvement in eQMS Selection:** The speaker strongly advocates for involving end-users in the eQMS selection process, emphasizing that their daily interaction with the system makes their input more valuable than C-suite preferences for successful adoption and usability. * **Veeva Vault's eQMS Capabilities and Limitations:** Veeva Vault's QMS module is described as "green" but strong in document management, often requiring integration with a separate Learning Management System (LMS) like ComplianceWire due to its weak native training capabilities. Its configurability is noted as a strength for those willing to learn the admin side. * **Regulatory Compliance and Data Integrity:** The video highlights the importance of robust audit trails and sufficient character limits in eQMS fields for detailed documentation, crucial for FDA audits, remediation projects, and avoiding issues like warning letters. Attaching external documents (e.g., Word files) for detailed descriptions can compromise audit trails. * **Defining eQMS Ownership and IT's Role:** For cloud-based eQMS, Quality Assurance, Regulatory, and Document Management departments should hold primary system ownership, not IT. IT's role should be limited to network uptime, single sign-on, and connector maintenance, not managing quality processes or system administration. * **Strategic Vendor Evaluation Beyond "Cadillac" Solutions:** Organizations should evaluate eQMS based on specific needs and organizational size, rather than defaulting to "Cadillac" systems like TrackWise or MasterControl. Thorough vetting of features, including character limitations, training modules, and out-of-the-box configurability, is essential. * **Navigating Implementation Challenges and Stakeholder Management:** Late-stage changes in eQMS selection, especially those overriding end-user decisions, can create a "semi-toxic environment" and project delays. Consultants must proactively manage internal politics, facilitate communication, and smooth over stakeholder friction to ensure project success.
Searching For ETMF Demoes
Big Gun Digital - Marketing Agency
/@biggundigital-marketingage7967
Nov 6, 2017
This video provides an in-depth exploration of a user's search habits when looking for Electronic Trial Master File (eTMF) solutions for a clinical organization running a drug trial. The speaker, Nick from Big Gun Digital, assumes the persona of a clinical professional whose current TMF solution is inadequate, prompting a search for new providers and demos. The core of the video demonstrates a practical, incognito approach to evaluating potential eTMF vendors, focusing on online resources to gather information discreetly before engaging directly. The demonstration begins with strategic Google searches, utilizing incognito mode to bypass personalized, geographically biased results and obtain a more transparent view of organic search outcomes. The speaker then critiques the initial search results, evaluating the relevance and quality of linked websites and their content, including calls-to-action, case studies, and testimonials. A significant portion of the video is dedicated to analyzing the online presence of various eTMF providers, assessing their website design, user experience, and the effectiveness of their marketing materials, particularly video content on YouTube. The speaker highlights the importance of easily accessible demos, clear navigation, and credible validation through client testimonials or case studies. Throughout the video, the speaker emphasizes the value of online resources like YouTube videos, webinars, and downloadable templates as preferred methods for initial vendor evaluation, allowing the user to remain "incognito" and avoid premature contact with sales teams, especially if they are competitive. He identifies YouTube as a particularly "untapped resource" for eTMF providers, noting the varying quality and organization of video content from companies like Documentum, Montrium, Flex Global, and Sure Clinical. The analysis extends to the structure of YouTube channels, the use of playlists, and the importance of detailed video descriptions for searchability, underscoring a broader critique of digital marketing effectiveness within the eTMF vendor landscape. Key Takeaways: * **Strategic Search for Enterprise Solutions:** The video demonstrates a practical approach to researching enterprise software, emphasizing the use of incognito browsing to obtain unbiased search results and prioritize online resources (videos, webinars, case studies) to gather information discreetly before direct vendor engagement. * **Importance of eTMF in Clinical Trials:** The scenario highlights the critical role of Electronic Trial Master File (eTMF) solutions in clinical organizations for managing drug trials, indicating that a robust eTMF system is essential for operational efficiency and compliance. * **Critique of Vendor Website Effectiveness:** The speaker provides a detailed critique of eTMF provider websites, noting issues such as bland design, poor navigation, lack of clear calls-to-action, and outdated content presentation, which can hinder a potential client's information-gathering process. * **Value of Online Demos and Video Content:** There's a strong preference for online video demos, webinars, and case studies, as they allow users to understand product capabilities and value propositions without immediate sales interaction. However, the content needs to be concise and high-quality to be effective. * **Ineffectiveness of Generic Testimonials:** The video points out that generic text-based testimonials on websites are often unconvincing. The speaker suggests that video testimonials or links to verifiable client profiles (e.g., LinkedIn) would significantly enhance credibility and trust. * **YouTube as an Untapped Resource:** YouTube is identified as a powerful yet underutilized platform for eTMF providers to showcase their solutions. Many companies have some video content, but often lack organized channels, clear calls-to-action in descriptions, or consistent content strategies. * **Optimizing YouTube Channel Management:** For businesses, creating dedicated business accounts, organizing videos into playlists, and writing comprehensive descriptions with relevant keywords and links are crucial for discoverability and user experience on YouTube. * **Content Quality and Length:** While video content is valued, promotional videos on landing pages should be short and engaging (e.g., under 5-10 seconds to capture attention), with longer, more detailed demos or educational content available elsewhere. * **Prominent Calls-to-Action:** Websites should feature prominent, easily discoverable calls-to-action (e.g., "Book a Demo") that stand out visually and are placed strategically throughout the page, not just at the very bottom. * **The TMF Reference Model:** The TMF Reference Model is mentioned as a key standard or framework within the eTMF space, suggesting its importance for document organization and compliance in clinical trials. * **Competitive Landscape Insights:** The search results suggest that while a few eTMF providers (e.g., Flex Global, Montrium, Documentum, Sure Clinical, Wingspan, Veeva) appear frequently, there might be an opportunity for new entrants or existing players to improve their digital marketing and content strategy to gain market share. * **Geographic Search Considerations:** The use of `google.co.uk` and specific location keywords (e.g., "Buckinghamshire") highlights the user's preference for local providers for potential physical demos, although the initial goal is to avoid them. Tools/Resources Mentioned: * Google Chrome (incognito mode) * YouTube * Google.co.uk * LinkedIn (TMF Reference Model group) * Veeva Systems (Veeva Vault eTMF) * Documentum * Montrium * Flex Global * Wingspan * Sure Clinical Key Concepts: * **Electronic Trial Master File (eTMF):** A specialized system designed for the electronic management of essential documents and records generated during clinical trials. eTMFs ensure that all trial-related documentation is complete, accurate, and readily accessible for regulatory inspections, supporting compliance with GxP and other regulatory requirements. * **Incognito Mode:** A privacy feature in web browsers that allows users to browse the internet without their browsing history, cookies, site data, or information entered in forms being saved. In the context of the video, it's used to prevent geographic bias in search results and maintain anonymity during initial research. * **TMF Reference Model:** A standardized, hierarchical model for organizing and managing clinical trial documents. It provides a common structure and terminology for the Trial Master File, facilitating consistency, efficiency, and regulatory compliance across different trials and organizations. The video mentions version 3.0 of this model.
Interactive models & data-driven presentations in Veeva
Petauri Evidence
/@PetauriEvidence
Nov 2, 2017
This video provides an in-depth exploration of leveraging Veeva for dynamic, data-driven market access presentations, challenging the common perception that Veeva is limited to static content. David Niziol, Managing Director of Mtech Access, begins by highlighting the prevalent issue where sophisticated health economic (HE) models and budget impact models (BIMs) are often developed as standalone applications, separate from Veeva. This separation leads to a significant loss of crucial CLM (Closed Loop Marketing) analytics, preventing pharmaceutical companies from understanding how these vital tools are utilized and received in the field. The presentation aims to demonstrate how, through innovative approaches, full functionality of dynamic tools can be achieved within the Veeva environment, ensuring comprehensive tracking and improved strategic insights. The core of the presentation focuses on Mtech Access's methodology for integrating complex, interactive tools into Veeva. They achieved this by extensively utilizing Veeva's custom objects to attach a data structure to presentations, effectively separating design from content. This approach allows for dynamic data loading, scenario creation, and multi-country support (handling different languages, currencies, and local data) directly within Veeva. Niziol explains that custom objects act like database tables, enabling read and write operations for dynamic content. The discussion emphasizes that by keeping market access materials within Veeva, companies can gain a complete picture of customer engagement, assess the effectiveness of their value propositions, and identify areas for strengthening evidence, which is lost when using third-party mobile device management systems for standalone apps. The webinar features two primary demonstrations. The first showcases an integrated Veeva budget impact model, specifically a conversion of an NICE costing template for diabetic foot ulcer prevention. This demo illustrates how users can dynamically select local health economy data (e.g., CCGs in England), customize population parameters, and generate bespoke impact analyses. Crucially, it demonstrates the creation of dynamic Approved Email summary reports that pull real-time results from the model, as well as the ability to save, load, and reset scenarios, and support multiple languages and currencies. The second demonstration introduces "Connected Insights," a platform developed by Mtech Access that allows users to build their own data visualization insight dashboards. This platform enables the import of internal data, creation of linked visualizations, and subsequent push to Veeva Vault for approval and distribution as CLM presentations, facilitating pre-engagement analysis and tailored communication with healthcare professionals. Key Takeaways: * **Veeva's Dynamic Potential:** Veeva is not limited to static content; it can host sophisticated, data-driven interactive tools, including health economic models and budget impact models, by leveraging its underlying architecture. * **Importance of CLM Analytics:** Integrating market access tools directly into Veeva ensures comprehensive CLM analytics, providing invaluable insights into tool usage, field reception, and the effectiveness of value propositions, which is often lost with standalone applications. * **Extending Veeva with Custom Objects:** Custom objects within Veeva can be used to create robust data structures, enabling dynamic content, multi-country support (languages, currencies, local data), and the ability to save and load user-defined scenarios within presentations. * **Centralized Data Management:** By utilizing custom objects, health economy data and other content can be centralized and managed in one place, accessible across multiple presentations, ensuring consistency and ease of updates. * **Key Functionalities for Integrated BIMs:** Effective budget impact models within Veeva require functionalities such as populating with local data, creating custom scenarios, calculating dynamic results, generating dynamic Approved Email summary reports, and supporting multi-country variations. * **Dynamic Approved Email:** Unlike traditional static Approved Emails, integrated models can generate dynamic reports that pull real-time, customized results from the interactive tool, providing bespoke summaries to customers. * **"Connected Insights" for DIY Dashboards:** Platforms like "Connected Insights" empower users to build custom data visualization dashboards from their own internal data, facilitating pre-engagement analysis and tailored presentations within the Veeva environment. * **Veeva API for Third-Party Integration:** Veeva provides API functions that allow for the integration of external tools and platforms, such as the "Connected Insights" dashboard builder, extending its capabilities beyond out-of-the-box features. * **Separation of Design and Content:** A key methodology involves separating the design of the presentation from its dynamic content, allowing for flexible updates and multi-language support without altering the core presentation structure. * **Strategic Pre-Engagement Analysis:** Interactive dashboards can be used to interrogate specific health economies, identify unmet needs, and build a compelling picture for a value proposition before engaging with customers. * **Regulatory Compliance Workflow:** Dashboards and dynamic content created externally can be pushed to Veeva Vault for approval, ensuring adherence to regulatory standards before deployment in CLM presentations. **Tools/Resources Mentioned:** * **Veeva:** Encompasses Veeva CRM, CLM (Closed Loop Marketing), Veeva Vault, and Approved Email functionalities. * **Mtech Access:** A market access and digital communication consultancy specializing in health economic models and digital tools. * **Connected Insights:** A platform developed by Mtech Access for building custom data visualization insight dashboards within the Veeva ecosystem. * **Salesforce.com:** Mentioned as the backend for detailed CLM analytics and reporting from Veeva. * **Google Translator:** Used as an example tool for translating content for multi-country support. * **NHS England:** Used as a data source example for obesity data in the Connected Insights demo. * **MobileIron / Watch:** Mentioned as third-party mobile device management systems often used for standalone apps, but which lead to a loss of CLM analytics. **Key Concepts:** * **Budget Impact Models (BIMs):** Calculators used by field teams to communicate the clinical and financial impact of changes in therapy to healthcare stakeholders. * **Health Economic (HE) Models:** Analytical tools that assess the economic value and consequences of healthcare interventions, often considering costs, outcomes, and resource utilization. * **CLM Analytics:** The process of tracking and analyzing interactions with marketing and sales content within a Closed Loop Marketing system (like Veeva CRM) to measure engagement and effectiveness. * **Veeva Custom Objects:** Configurable data structures within Veeva CRM that allow users to store and manage custom data, extending the platform's functionality beyond standard objects. * **Veeva API:** An Application Programming Interface provided by Veeva that allows external applications to interact with and exchange data with Veeva systems. * **Approved Email:** A Veeva feature that enables the creation, approval, and sending of compliant email communications to healthcare professionals. * **Veeva Vault:** A cloud-based content management system specifically designed for the life sciences industry, ensuring regulatory compliance for documents and content. * **Market Access:** The process of ensuring that new pharmaceutical products or medical devices are available and affordable to patients, often involving health economic evaluations and stakeholder engagement. **Examples/Case Studies:** * **Diabetic Foot Ulcer Prevention Model:** A demonstration of a budget impact model, converted from an NICE costing template, integrated into Veeva. It showed how field teams could select specific health economies (e.g., CCGs in England), adjust patient population parameters, and visualize the financial impact of orthotic footwear on reducing amputations and ulcers. The model dynamically generated a bespoke summary report for Approved Email. * **Connected Insights Dashboard:** A platform demonstration where a user built a custom data visualization dashboard using obesity data from NHS England. The dashboard allowed for the visualization of prevalence rates, demographic breakdowns, and prescription information for selected CCGs, illustrating how to interrogate an environment for unmet needs before a customer engagement. This dashboard could then be pushed to Veeva Vault for approval and deployed as a CLM presentation.
Challenges with Clinical Data Management: Findings by Tufts
Veeva Systems Inc
@VeevaSystems
Oct 24, 2017
This video provides an in-depth exploration of the challenges and opportunities in clinical data management, drawing upon findings from a recent Tufts University study commissioned by Veeva Systems. Richard Young, Vice President of Vault EDC at Veeva Systems, discusses the evolving landscape of electronic data capture (EDC) and the increasing complexity of clinical trials. The core purpose of the study was to examine current and evolving EDC and clinical data usage practices across drug development, specifically questioning whether traditional systems are still fit for purpose given the growing demands of data collection, management, and reporting. The study surveyed over 250 senior industry professionals with an average of 20 years of experience, aiming to surface current and future challenges in the field. Young highlights a critical issue with the term "EDC" itself, noting that traditional EDC systems, often built in the 1990s, primarily function as electronic case report forms (eCRFs), capturing only 20-30% of the total study data. This leaves a vast amount of diverse data—such as lab data, biomarkers, PK data, and increasingly, millions of data points from mobile health devices like Fitbits and Garmins—unmanaged by these systems. He introduces a four-stage framework for data management: "design, collect, decide, and act." The challenges users face stem from the inability of outdated systems to support designing the trial one truly wants to run, collecting all necessary data types, making confident and timely decisions based on comprehensive data, and acting effectively on those decisions amidst growing project complexity. A key finding from the Tufts research reveals a strong correlation between the initial stages of a clinical trial and subsequent delays. The study demonstrated that delays in building the study database directly lead to longer data entry times and slower database lock times. This insight underscores the principle that "if you start behind, you never catch up," emphasizing the critical need for upfront efficiency and robust preparation. Young further discusses the "four V's" of clinical data management—Volume, Variety, Velocity, and Veracity—which collectively lead to the "fifth V," Value. He stresses that the sheer volume of data, its diverse formats, the demand for real-time access, and the understanding that not every data point requires absolute perfection (veracity, focusing resources on critical data) are paramount considerations for modern data management strategies. Veeva's proposed solution is a unified, "true platform" that seamlessly consolidates data, content, and workflows, addressing the industry's current reliance on over 160 disparate systems. Key Takeaways: * **Outdated EDC Systems:** Traditional Electronic Data Capture (EDC) systems, often developed in the 1990s, are no longer fit for purpose. They primarily function as electronic forms, capturing only 20-30% of total clinical study data and failing to manage the growing volume and variety of modern data sources. * **Expanding Data Landscape:** Clinical trials now involve a vast array of data beyond traditional eCRFs, including lab data, biomarkers, PK data, and millions of data points from mobile health devices (e.g., Fitbits, Garmins). Current systems struggle to integrate and manage this diverse and high-volume data. * **The "Design, Collect, Decide, Act" Framework:** Effective data management can be broken down into four critical stages: designing the trial without technological limitations, collecting all types of relevant data, making confident and timely decisions based on comprehensive data, and acting decisively on those insights. * **Correlation of Early Delays to Later Inefficiencies:** The Tufts study revealed a direct and perfect correlation: delays in building the study database significantly prolong data entry times and slow down database lock. This highlights the critical importance of upfront planning and efficient setup. * **"If You Start Behind, You Never Catch Up":** This powerful insight from the research emphasizes that initial project delays create a cascading effect, leading to persistent inefficiencies throughout the clinical trial lifecycle. Proactive and timely execution in early phases is crucial. * **The Four V's of Clinical Data:** Modern clinical data management must contend with: **Volume** (exponential growth, e.g., billions of data points per patient from mobile health), **Variety** (diverse data types and formats), **Velocity** (demand for real-time access and processing), and **Veracity** (strategic focus on the most important data points, acknowledging that not all data requires absolute perfection). * **Achieving Data Value:** By effectively managing the four V's, organizations can unlock the "fifth V"—Value. The goal is to ensure systems help identify the true value of data to drive better decisions, primarily concerning patient safety and efficacy. * **Industry's System Fragmentation:** A major challenge in pharma is the use of numerous disparate systems (some companies use over 160 systems for data management, clinical, and statistical work), leading to inefficiencies, data silos, and integration complexities. * **Need for a Unified Platform:** The vision for the future of clinical data management involves a unified, "true platform" capable of managing all data, content, and workflows concurrently and seamlessly. Such a platform would enable data flow to all consumers and contributors without delay, driving actions and informing decisions. * **Seamless Consolidation:** A unified platform should facilitate the seamless consolidation not just of structured data, but also unstructured data (e.g., Twitter feeds), content (documentation), and workflows. This integration is essential for comprehensive oversight and operational efficiency. Tools/Resources Mentioned: * **Veeva Systems Inc:** The company that commissioned the Tufts study and whose Vice President of Vault EDC was the speaker. Veeva is presented as a leader in cloud-based software for the global life sciences industry, advocating for a unified platform approach. * **Tufts University:** Specifically, Tufts Center for the Study of Drug Development (CSDD), which conducted the research study on clinical data management and EDC practices. * **EDC (Electronic Data Capture):** The primary technology discussed, though the video highlights its limitations in its traditional form. * **Mobile Health Devices (Fitbits, Garmins):** Mentioned as examples of sources generating massive volumes of new clinical data. Key Concepts: * **eClinical Landscape:** Refers to the ecosystem of electronic systems and processes used in clinical trials, including EDC, clinical trial management systems (CTMS), and other data management tools. * **Database Build Delays:** The time taken to set up and validate the study database before patient enrollment, identified as a critical factor impacting subsequent trial timelines. * **Data Entry Cycle Times:** The duration from patient visit to the transcription of data into the EDC system. * **Database Lock:** The final stage of data management where the clinical database is finalized and locked for analysis, a key milestone in trial completion. * **Four V's of Data (Volume, Variety, Velocity, Veracity):** A framework used to characterize the challenges and requirements of managing big data, applied here specifically to clinical data. * **Volume:** The sheer amount of data being generated. * **Variety:** The different types and formats of data. * **Velocity:** The speed at which data is generated, processed, and accessed. * **Veracity:** The quality, accuracy, and trustworthiness of the data, with an emphasis on strategically focusing resources on the most critical data points rather than striving for absolute perfection across all. * **Unified Platform:** A single, integrated software solution designed to manage all aspects of data, content, and workflows across an enterprise, contrasting with fragmented, bolted-together systems.
A Pulse on the EDC Landscape
Veeva Systems Inc
/@VeevaSystems
Oct 24, 2017
This video provides an in-depth critical assessment of the current Electronic Data Capture (EDC) landscape in clinical trials, arguing that traditional systems are obsolete and detailing the requirements for next-generation data solutions. Featuring Richard Young, Vice-President of Vault EDC at Veeva Systems, the discussion establishes that while EDC was originally conceived to speed up data review, the current status quo—largely unchanged for 40 years—has failed to keep pace with the dramatic evolution of clinical trial complexity and data volume. Young asserts that traditional EDC should be declared "unfit for purpose," functioning merely as a remote data entry system focused on digitizing paper Case Report Forms (CRFs), which represents only about 10% of total study data. The core problem identified is the inability of legacy systems to manage the massive influx of diverse, complex data streams now integral to modern research. Beyond standard CRF and lab results, today's trials must incorporate data from mHealth devices, social media, genomics, and proteomics. These data types present huge volumes, varieties, and complexities that must be acquired, aggregated, managed, and reported in real-time. The next-generation solution must therefore be a "total data solution," unlimited by size, scope, or speed, designed to handle any data source in stream. Furthermore, it must connect all contributors and consumers of clinical data—patients, nurses, data managers, and researchers—under a single, unified platform, eliminating the need to prioritize one user set over another. To guide this transformation, the speaker introduces the strategic framework of "Collect, Decide, Act." This methodology demands a truly digital strategy where all data is complete and concurrent ("all of my data, all of the time"). When big data is managed effectively, it becomes "smart data," enabling study teams to make better decisions with greater confidence and speed. This capability is paramount for advancing clinical research designs, such as personalized medicine, precision medicine, and adaptive trials, which require systems that embrace change. Running suboptimal studies because of technological limitations is deemed unacceptable, and modern technology must allow decisions to be implemented in minutes, not weeks or months, to truly support adaptive protocols. The ultimate goal for the industry is to move beyond the constraints of technology and empower teams to "design the trial you want." This means pulling every data point into the continuum to transform raw data into actionable insights. The technology must not only facilitate the collection and analysis of data but also enable the rapid implementation of conclusions, ensuring that systems do not resist or create barriers to necessary operational changes required by modern, dynamic trial designs. Key Takeaways: • Traditional EDC systems are fundamentally flawed and should be declared "unfit for purpose" as they remain largely unchanged from their conception 40 years ago, functioning primarily as remote data entry tools. • The modern clinical trial landscape requires managing vast, complex data streams—including genomics, proteomics, mHealth, and social media—which traditional systems cannot acquire, aggregate, or report efficiently in real-time. • Next-generation EDC must evolve into a "total data solution" capable of handling any data source in stream, unlimited by size, scope, or speed, moving beyond the digitization of paper CRFs (which account for only 10% of study data). • Modern solutions must unify all clinical trial stakeholders (patients, sites, data managers, etc.) under a single platform, eliminating the historical necessity of prioritizing one set of users over another. • The strategic framework for effective clinical data management is "Collect, Decide, Act," emphasizing the need for complete data collection, rapid insight derivation, and immediate implementation of conclusions. • Achieving a truly digital strategy requires "complete and concurrent data" (all data, all the time) to convert raw big data into "smart data," enabling faster, more confident decision-making. • Technology must actively support advanced trial designs like adaptive trials and personalized medicine by embracing change; systems must allow decisions to be implemented in minutes, not weeks or months. • Running suboptimal studies due to technological limitations is unacceptable; the industry must demand technology that allows study teams to design the most effective trial possible without constraints. • The focus of clinical data management must shift from merely digitizing paper toward a comprehensive digital strategy that optimizes the entire research process. • The speaker emphasizes that modern systems must be designed to allow study teams to make insightful, accurate, and balanced decisions based on comprehensive data analysis. • Veeva Vault EDC is positioned as a solution that delivers a flexible, modern cloud application designed to streamline clinical operations by unifying EDC, eSource, CTMS, and eTMF. Tools/Resources Mentioned: * Veeva Vault EDC * Veeva Systems Key Concepts: * **EDC (Electronic Data Capture):** The system used for electronic collection and management of clinical trial data. * **Total Data Solution:** A next-generation EDC concept that handles all data sources (mHealth, genomics, etc.) regardless of volume or complexity, moving beyond the limited scope of traditional CRF data. * **Collect, Decide, Act:** A strategic framework for clinical data management emphasizing comprehensive data acquisition, rapid analysis, and immediate operational implementation based on insights. * **Smart Data:** Actionable insights derived from the effective processing and aggregation of large volumes of raw clinical data, enabling faster and more confident decision-making.
Ken Getz: Findings from 2017 eClinical Landscape Study
Veeva Systems Inc
@VeevaSystems
Oct 24, 2017
This presentation summarizes the key findings of the 2017 eClinical Landscape Study, a baseline assessment conducted by Tufts (Ken Getz) focusing on the current state of clinical data and data management practices across the pharmaceutical and life sciences industries. The study surveyed nearly 260 companies, primarily sponsors and Contract Research Organizations (CROs), providing an aggregate view of industry experiences and practices, highlighting areas where expectations were affirmed and where surprising challenges emerged regarding efficiency and data handling. One of the study’s key affirming findings was the significant and growing diversity and heterogeneity of data elements being collected in clinical trials. Data is no longer confined to Electronic Case Report Forms (eCRF) via Electronic Data Capture (EDC) systems, but now includes inputs from social media, online communities, smartphones/mobile applications, and Real-World Evidence (RWE). This proliferation means clinical data must be integrated from numerous, often incompatible sources, creating substantial complexity and challenges for data management teams tasked with standardization and quality control. Despite numerous industry efforts and technological advancements aimed at accelerating clinical development, the study revealed surprising insights regarding cycle times. The time required to manage and lock the data—the cycle time from the last patient visit to database lock (DBL)—remains stubbornly long and has not significantly decreased. Furthermore, the analysis uncovered significant downstream effects of data management challenges, particularly impacting site personnel. Delays in database build and release, often associated with protocol changes or functionality requirements, directly increase the time site staff must spend entering patient data, creating friction and inefficiency at the clinical site level. The study specifically measured and discriminated the impact of various causes of delay, finding that while protocol design changes are the most frequent, changes to the database design itself and its underlying functionality have the most profound negative impact on the final study closeout cycle time (last patient last visit to DBL). The research also provided insight into operational advantages within the ecosystem, noting that CRO companies tend to offer a speed advantage across most data management timelines, including database build/release and DBL. This speed is attributed, in part, to the CRO’s more standardized and systematic approach, driven by the need to maintain efficiency against a predefined budget and plan. Ultimately, the study concludes that the industry is only at the very beginning of an evolutionary period regarding clinical data diversification. Organizations must anticipate the implications of this growing data complexity and prepare to fundamentally change their data management practices to cope with the influx of heterogeneous data sources. Key Takeaways: • **Data Heterogeneity is a Baseline Challenge:** Clinical trials are increasingly reliant on diverse data sources beyond traditional EDC, including RWE, social media, and mobile applications, necessitating robust data integration strategies to handle incompatible formats and sources. • **Stagnant Data Management Cycle Times:** Despite industry focus on acceleration, the cycle time required for data management, particularly the duration from last patient last visit to database lock (DBL), has not improved, indicating fundamental inefficiencies remain unaddressed. • **Database Design Impacts DBL Most Severely:** While protocol changes are the most frequent cause of delays in database build, changes to the database design and functionality itself have the largest measurable impact on extending the critical DBL cycle time at the closeout of the study. • **Downstream Effects on Site Personnel:** Data management challenges, such as delays in database release, directly increase the burden on site personnel, forcing them to spend more time on data entry and potentially impacting data quality and site satisfaction. • **CROs Offer a Speed Advantage:** Contract Research Organizations (CROs) generally demonstrate faster timelines across key data management metrics (database build, DBL) compared to sponsors, likely due to their systematic, standardized operational approaches and efficiency focus. • **Anticipate Evolutionary Change:** The diversification of clinical data is viewed as being in its nascent stages; companies must proactively anticipate and adapt their data management practices to handle the coming wave of complex, non-traditional data. • **Focus on Functionality Stability:** To reduce cycle times, organizations should prioritize finalizing and stabilizing database design and functionality early in the study lifecycle, as changes here create the greatest drag on study closeout. • **Integration of Incompatible Sources:** The need to integrate data from incompatible sources presents a major technical hurdle, demanding advanced data engineering solutions and robust data pipelines to normalize and harmonize disparate datasets. • **Need for Automation in Data Management:** The persistent length of data management timelines suggests a critical need for automation and intelligent systems to streamline data cleaning, reconciliation, and quality checks, particularly given the increase in data volume and variety. Key Concepts: * **eClinical Landscape:** Refers to the technological ecosystem and practices surrounding the collection, management, and analysis of clinical trial data. * **Cycle Time (Last Patient Last Visit to DBL):** A critical metric in clinical trials measuring the efficiency of data management and quality control processes from the end of patient treatment/observation until the final database is locked for analysis. * **Data Heterogeneity:** The state of clinical data originating from many different sources (EDC, RWE, mobile apps) and existing in various formats, often requiring significant effort to integrate and standardize. * **Real-World Evidence (RWE):** Data collected outside of traditional randomized controlled trials, such as electronic health records, claims data, and patient-generated data, increasingly used to support clinical decisions.
Orcanos ALM and Quality Management System (QMS) First Time Tutorial
Orcanos
/@OrcanosMedical
Oct 23, 2017
This video provides an introductory tutorial to Orcanos ALM (Application Lifecycle Management) and QMS (Quality Management System), demonstrating its core functionalities for managing projects, requirements, testing, risk, and documents within a regulated environment. The speaker guides users through the initial setup and navigates the system's various modules, emphasizing how Orcanos facilitates compliance and operational efficiency by centralizing critical development and quality processes. The tutorial begins with a simple onboarding process, allowing users to select a project type and name, after which the system automatically creates the project structure. It then introduces the "product tree," a hierarchical representation of project documents and electronic records, such as market, system, software, hardware, and mechanical requirements. The video provides an overview of the system's interface, including a user area for personalization, a modules menu to switch between views (product tree, dashboard, work items, document control, service center, admin), a project selector, and a search panel. Dashboards are highlighted as customizable areas for reports and quick access to tutorials, demonstrating the system's flexibility in presenting relevant information. A significant portion of the tutorial focuses on managing electronic records and ensuring traceability. It illustrates how to navigate the product tree to view specific documents, such as a software requirement document, which contains headings and actual requirements, each assigned a unique identifier. The process of adding new work items, like a software requirement, is demonstrated, emphasizing that Orcanos uses "work items" as a versatile concept for managing various electronic forms, including defects, test cases, and CAPAs. The video also showcases the "tracing mode," a dual-pane interface that allows users to easily link low-level items (e.g., test cases) to high-level items (e.g., software requirements), establishing critical traceability for validation and compliance. Finally, the tutorial delves into document control and administrative features. The document control module offers a hierarchical view of workspaces, folders, and DMS (Document Management System) items, enabling users to upload and manage documents with version control (revisions). Electronic signatures are mentioned as a key feature for tracking progress and defining routing processes. The administration section is presented as a comprehensive control panel for customizing nearly every aspect of the system, including user and group management, project configuration, electronic form customization, custom fields, traceability rules, data sharing, alerts, email notifications, and add-ons like the DMS importer and DocGen for exporting data. The FMEA panel for risk management is also briefly highlighted, underscoring the system's integrated approach to quality and compliance. Key Takeaways: * **Integrated ALM and QMS:** Orcanos provides a unified platform for Application Lifecycle Management and Quality Management System, covering requirements, testing, risk, CAPA, and document control, which is crucial for regulated industries like life sciences. * **Hierarchical Product Tree for Electronic Records:** The system organizes project data, including various types of requirements (market, system, software, hardware), into a hierarchical "product tree," representing electronic records that can be generated into formal documents. * **Robust Requirements Management:** Users can easily add and manage requirements, each assigned a unique identifier and prefix, facilitating clear tracking and management throughout the product lifecycle. * **Critical Traceability Functionality:** Orcanos features a "tracing mode" that enables linking low-level items (e.g., test cases) to high-level items (e.g., requirements), which is essential for demonstrating compliance and validation in regulated environments. * **Comprehensive Document Control (DMS):** The system includes an electronic Document Management System for organizing, uploading, and managing documents with revision control, supporting GxP and 21 CFR Part 11 requirements. * **Electronic Signatures for Compliance:** Electronic signature capabilities are integrated, allowing for tracking progress and defining routing processes, which is vital for audit trails and regulatory adherence. * **Flexible "Work Items" Concept:** Orcanos utilizes "work items" as a versatile framework for managing various electronic forms, including requirements, defects, test cases, and CAPAs, enabling standardized data capture. * **Extensive Customization Options:** The administration panel allows for deep customization of electronic forms, custom fields, traceability rules, user roles, and permissions, adapting the system to specific organizational needs and regulatory frameworks. * **Integrated Risk Management (FMEA):** A dedicated FMEA panel signifies the system's built-in capabilities for risk management, a cornerstone of quality systems in medical device and pharmaceutical development. * **Collaborative Features:** The system supports simultaneous work on documents, data sharing settings, and configurable alerts and email notifications based on events, fostering team collaboration and oversight. * **Add-ons for Data Integration:** Orcanos offers add-ons like a DMS importer for migrating existing QMS data and a DocGen tool for exporting data into standard formats (MS Word, PDF), enhancing data portability and integration. * **Project-Specific User Roles:** Users can be assigned different roles and permissions across multiple projects, allowing for granular control over access and responsibilities (e.g., a user can be a developer in Project A and a tester in Project B). Tools/Resources Mentioned: * Orcanos ALM (Application Lifecycle Management) * Orcanos QMS (Quality Management System) * Orcanos DMS Importer (add-on for importing existing QMS documents) * Orcanos DocGen (add-on for exporting data to MS Word or PDF) Key Concepts: * **ALM (Application Lifecycle Management):** A comprehensive approach to managing the life cycle of an application, from conception to retirement. * **QMS (Quality Management System):** A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. * **Requirements Management:** The process of documenting, analyzing, tracing, prioritizing, and agreeing on requirements and then controlling change and communicating to relevant stakeholders. * **Test Management:** The process of managing tests, including planning, designing, executing, and reporting on test activities. * **FMEA (Failure Mode and Effects Analysis):** A systematic, proactive method for evaluating a process, product, or service to identify where and how it might fail and to assess the potential impact of different failures. * **CAPA (Corrective and Preventive Actions):** Processes for identifying, documenting, and eliminating the causes of nonconformities and preventing their recurrence. * **Document Control:** The process of managing documents throughout their lifecycle, including creation, review, approval, distribution, and archiving, ensuring their accuracy and availability. * **Electronic Signature:** A digital equivalent of a handwritten signature, used to authenticate the identity of the signer and the integrity of the signed data, often critical for regulatory compliance (e.g., 21 CFR Part 11). * **Traceability:** The ability to track the relationship between different items (e.g., requirements to test cases, or design specifications to verification activities), crucial for validation and auditability. * **Work Items:** A generic term used in Orcanos to represent any managed electronic form or record within the system, such as requirements, defects, test cases, or CAPAs. * **Product Tree:** A hierarchical visual representation of all project-related documents and electronic records within the Orcanos system. * **DMS (Document Management System):** A system used to store, manage, and track electronic documents and electronic images of paper-based information. Examples/Case Studies: * **Project Onboarding:** Demonstrates creating a new project by selecting a project type and setting a name. * **Hierarchical Document Structure:** Illustrates the "product tree" with examples like "market requirements spec," "system requirements spec," "software requirements," "hardware requirements," and "mechanical requirements," showing how documents and headings are structured. * **Adding a Software Requirement:** Shows the process of creating a new "software requirement" work item, giving it a name and description, and noting its unique identifier. * **Creating Traceability:** Demonstrates linking a "test case" (low-level item) to a newly created "software requirement" (high-level item) using the tracing mode and defining a "test coverage" link type. * **Document Upload and Revision:** Illustrates adding a "software test result document" to a folder within document control by dragging and dropping a file, noting that each change increases the document's revision number.
Quality Digest LIVE, October 20, 2017
Quality Digest
/@QualityDigest
Oct 20, 2017
This video from Quality Digest LIVE, dated October 20, 2017, provides an in-depth exploration of quality management topics, with a significant focus on the transformative impact of cloud-based Quality Management System (QMS) software solutions. The program features an interview with Frank de Fish, Senior Vice President and General Manager of Veeva Systems, who discusses how cloud QMS empowers quality departments and shifts the dynamic between IT and quality teams. Additionally, the episode covers the importance of ISO 13485:2016 for quality management in the medical device sector and briefly touches upon data interoperability in intelligent supply chains and even an unusual renewable energy source. The core of the discussion centers on the evolution of QMS from traditional on-premise, IT-driven systems to agile, user-centric cloud platforms. De Fish explains that historically, IT departments held the sole expertise for procuring, installing, and maintaining QMS software, often leading to solutions that didn't fully meet quality teams' needs. Cloud QMS, by transferring the technical burden to the software vendor, allows quality departments to "take the driver's seat." This shift fosters a stronger, more collaborative relationship between quality and IT, as IT can now focus on supporting the business rather than managing complex software infrastructure. De Fish elaborates on the three key benefits of cloud QMS: enhanced usability, flexibility, and accessibility. Cloud software, much like consumer applications such as Google or Amazon, prioritizes an intuitive user experience, making it easier for non-technical users to adopt and utilize. Its flexibility stems from point-and-click configuration rather than complex coding, enabling quality teams to adapt the system quickly to new ISO standards or best practices without relying on IT. Furthermore, cloud QMS offers universal access via any internet browser, from any device, anywhere in the world, extending its reach to external suppliers, contract manufacturers, and even auditors, facilitating seamless collaboration and compliance. The interview highlights tangible business improvements enabled by cloud QMS, drawing parallels to the advancements seen in CRM software when sales organizations gained decision-making power. These improvements include the ability to integrate external partners into the QMS for activities like completing investigations, signing off with 21 CFR Part 11 compliant electronic signatures, or uploading batch files directly, thereby eliminating blind spots in audit trails and enhancing accountability. Cloud QMS also significantly increases speed, allowing quality teams to generate reports and implement workflow changes in response to regulatory shifts much faster, without lengthy IT queues. The discussion also touches upon the critical role of ISO 13485:2016 in the medical device industry, emphasizing its importance for managing the high-risk profile of medical products and ensuring both regulatory compliance and financial performance. Key Takeaways: * **Empowerment of Quality Departments:** Cloud-based QMS solutions fundamentally shift control from IT to quality teams, allowing them to select, manage, and optimize their quality systems directly. This transition enables quality departments to make quicker, more informed decisions that better align with their operational needs. * **Enhanced Usability and Adoption:** Cloud QMS prioritizes user-friendliness, mirroring the intuitive interfaces of consumer web applications. This ease of use is crucial for widespread adoption within an organization, especially since not all users interact with the QMS daily, ensuring better data visibility and decision-making. * **Flexibility Through Configuration, Not Code:** Unlike traditional software requiring extensive coding, cloud QMS allows modifications through simple point-and-click configurations. This empowers quality professionals, even those without coding expertise, to adapt the system to evolving regulatory requirements (e.g., new ISO standards) and best practices efficiently. * **Universal Accessibility:** Cloud QMS can be accessed from any device, browser, or location with an internet connection, eliminating the need for complex VPNs or specialized installations. This broad accessibility facilitates collaboration across internal teams and external partners like suppliers and contract manufacturers. * **Streamlined Procurement and Cost Predictability:** The procurement process for cloud QMS is significantly simpler, as it eliminates the need for purchasing and maintaining additional hardware, software, or network infrastructure. Companies benefit from predictable subscription-based licensing, simplifying total cost of ownership analysis. * **Improved External Partner Integration and Compliance:** Cloud QMS enables seamless integration with external suppliers and contract manufacturers, allowing them to directly participate in QMS processes, such as completing investigations, uploading batch files, and providing 21 CFR Part 11 compliant electronic signatures. This enhances accountability and closes audit trail blind spots. * **Increased Operational Speed and Agility:** Quality teams gain the ability to generate reports and implement workflow changes in response to regulatory updates or internal needs without lengthy delays caused by IT backlogs. This agility is critical for maintaining compliance and continuous improvement in a dynamic regulatory landscape. * **Criticality of ISO 13485 for Medical Devices:** ISO 13485:2016 is highlighted as a paramount standard for quality management systems in the medical device industry. Its proper implementation is essential for mitigating the high-risk profile of medical products, ensuring patient safety, and balancing regulatory adherence with business performance. * **Value of Expert Guidance for Standards:** The discussion emphasizes the importance of handbooks and guides written by technical committees (like ISO TC 210 for ISO 13485) to help organizations, auditors, certification bodies, and regulatory agencies better understand and implement complex standards. * **Future Innovation in Quality Software:** The shift to cloud platforms is expected to drive significant innovation in quality software, similar to how cloud adoption revolutionized CRM. This will lead to continuous improvements in quality processes and tools, further optimizing operations in regulated industries. **Tools/Resources Mentioned:** * **Veeva Systems:** A company providing cloud-based software solutions for the life sciences industry. * **Veeva Vault QualityOne:** A specific cloud-based QMS product from Veeva Systems. * **ISO 13485:2016:** The international standard for quality management systems for medical devices. * **ISO 13485:2016 Medical Devices: A Practical Guide:** A handbook published by ISO to aid in the understanding and implementation of ISO 13485:2016. **Key Concepts:** * **Cloud QMS (Quality Management System):** A QMS delivered as a service over the internet, eliminating the need for on-premise hardware and IT management, offering benefits like scalability, accessibility, and ease of use. * **21 CFR Part 11:** Regulations issued by the FDA concerning electronic records and electronic signatures, which are critical for ensuring the integrity and authenticity of digital data in the pharmaceutical and life sciences industries. * **ISO 13485:** An international standard that specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. * **Data Interoperability (in QMS context):** The ability of different QMS components and external systems (e.g., with suppliers) to exchange and make use of data, crucial for maintaining a complete and accurate audit trail and ensuring compliance. **Examples/Case Studies:** * **New Chapter and Procter & Gamble:** Both companies are mentioned as users of Veeva Vault QualityOne, illustrating its applicability across different organizational sizes (New Chapter being smaller, P&G a large parent company).
Thinking High and Low: Veeva’s Secrets to Success
Emergence Playbook
/@emergenceplaybook9583
Sep 29, 2017
This video provides a deep dive into Veeva Systems' journey and strategic principles, as shared by its Founder & CEO, Peter Gassner. It covers Veeva's foundational philosophy, its evolution from a cloud solutions provider to building the "industry cloud for Life Sciences," and the practical approaches to leadership, product development, sales, and financial management that have driven its success. Gassner emphasizes the importance of a clear vision and values, customer-centricity, and a long-term perspective in building an industry-specific enterprise software company. The discussion also touches on the ever-changing technology landscape and the CEO's critical role in making informed platform decisions and fostering a culture of excellence and self-improvement. Key Takeaways: * **Vision-Driven Strategy:** Veeva operates on a clear vision and values (customer success, employee success, speed) that guide all major decisions. Their aspirational new vision to "build the industry cloud for Life Sciences" aims to make Veeva an essential and appreciated partner, improving how customers bring life-saving drugs to patients. * **CEO's Core Responsibilities:** A CEO's primary job involves picking clear and correct target markets, ensuring engaged teams work together (understanding the difference between the team you lead and the team you're on), and making quick, clear, and hopefully correct decisions. * **Industry Cloud Product Excellence:** For an industry cloud, product excellence means aiming for leadership from day one, assembling the best domain experts, and crucially, *running towards complexity* rather than away from it. This involves taking on the integration burden for customers by offering deeply integrated, industry-specific products. * **Long-Term Field Model:** Veeva's sales and service model is based on reference selling, focusing on getting early adopters live and happy. Sales takes a long-term view, prioritizing strategic partnership over quarterly quotas, and services are staffed by domain experts who act as "pollinators" of industry knowledge. * **Disciplined Financial Management:** The company maintains financial discipline with a "spend it like it's your own" rule, starting from the CEO. This includes disciplined product planning, a bias towards organic growth, and a focus on both top-line and bottom-line performance. * **Strategic Technology Platform Decisions:** CEOs must actively pay attention to the rapidly shifting technology landscape (infrastructure, system software, application platforms). It's critical to make conscious, economic decisions about leveraging external platforms versus building proprietary ones, rather than passively adopting technologies. * **Continuous Self-Improvement for Leaders:** Gassner stresses that a CEO's greatest contribution to the company is continuous self-improvement. Leaders must actively identify areas for growth and work to improve themselves, as they have the most control over their own development.
eTMF Quality Oversight Trailer
Kathy Barnett
/@kathybarnett4070
Sep 21, 2017
This video provides an in-depth exploration of applying risk-based assessment to electronic Trial Master File (eTMF) quality control (QC) activities to ensure inspection readiness in clinical trials. The speaker, a clinical research veteran with over 25 years of experience, including 15 years in large pharma and extensive consulting in clinical compliance and GCP inspections, emphasizes the critical role of a high-quality TMF in achieving drug approval. The session aims to outline various QC activities, identify key artifacts with significant quality risks, and align TMF management with Health Authority expectations, particularly concerning FDA and EMA inspections. The core concept presented is that the TMF serves as the complete "story of the study," documenting everything from its inception to conclusion without requiring additional explanation. The speaker stresses that regulatory investigators prioritize documented evidence over subject matter expert interviews, making the TMF the ultimate proof of trial conduct, data integrity, and GCP compliance. This comprehensive story extends beyond just clinical records, encompassing documentation from all functional areas involved in the study. The presentation also touches upon the speaker's experience with 21 CFR Part 11, ensuring the discussion covers both paper and electronic applications of TMF quality review. A significant portion of the discussion focuses on the unpredictable nature of regulatory inspections. The speaker shares real-world examples of inspectors making diverse and often sudden demands, such as requesting the entire eTMF on a thumb drive or shifting focus to unrequested documents during an inspection. This unpredictability underscores the necessity for sponsors to maintain a consistently high-quality, inspection-ready TMF rather than attempting to anticipate specific inspector requests. The video concludes by highlighting the importance of a comprehensive content list for the TMF, which defines all necessary records to meet regulatory expectations. Key Takeaways: * **Risk-Based TMF Oversight:** A risk-based approach is crucial for eTMF quality oversight, combining the potential for quality issues with their impact on TMF integrity and overall Good Clinical Practice (GCP) compliance. This proactive strategy helps prioritize QC efforts. * **TMF as the Study's Narrative:** The TMF must function as the complete, standalone "story of the study," detailing all events from beginning to end without needing external explanations. It is the definitive record for recreating study activities. * **Regulatory Inspection Readiness:** The ultimate goal of TMF management is inspection readiness, which is paramount for securing drug approvals. A high-quality TMF is the cornerstone for demonstrating compliance to Health Authorities. * **Documentation Over Interviews:** Health Authority investigators (e.g., FDA, EMA) primarily rely on documentation within the TMF as evidence of compliance and study conduct. What was *said* is less important than what is *documented*. * **Unpredictable Inspection Demands:** Sponsors must be prepared for varied and often unexpected inspection requests, such as providing the eTMF on a thumb drive or inspectors reviewing documents not initially requested. Planning for a consistently high-quality TMF is more effective than trying to predict specific demands. * **Comprehensive TMF Content:** A quality TMF extends beyond just clinical records to include documentation from all functional areas involved in the study. It's not merely a collection of records but a complete, integrated story. * **Definition of a Quality TMF:** A quality TMF is defined as a collection of records that is complete, collected in a timely manner, and comprised of high-quality individual records. * **GCP Compliance:** The TMF is used by Health Authorities to evaluate the conduct of the trial according to protocol, the integrity of the data, and overall compliance with GCP. * **21 CFR Part 11 Expertise:** The speaker's experience with 21 CFR Part 11 ensures that the discussion on TMF quality review is applicable to both paper-based and electronic systems, addressing critical regulatory requirements for electronic records. * **Importance of QC Activities:** Implementing robust quality control (QC) activities is essential for ensuring a high-quality eTMF. Findings from these reviews should drive further quality improvement actions. * **Impact of Quality Deficiencies:** Deficiencies in TMF quality can significantly impact the integrity of the TMF and the overall GCP compliance of the study, potentially jeopardizing regulatory approval. * **TMF Reference Model:** The speaker's involvement with the TMF Reference Model revisions highlights the importance of standardized approaches to TMF content and structure for enhanced quality and inspection readiness. Key Concepts: * **eTMF (electronic Trial Master File):** The electronic version of the Trial Master File, 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. * **Risk-Based Assessment:** A methodology for prioritizing quality control efforts based on the likelihood of issues occurring and the potential impact of those issues on data integrity and regulatory compliance. * **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. * **Inspection Readiness:** The state of being fully prepared to present all required documentation and demonstrate compliance to regulatory authorities during an audit or inspection. * **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 and handwritten signatures. * **Health Authority:** Governmental bodies responsible for regulating the pharmaceutical and healthcare industries, such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency). Examples/Case Studies: * **FDA Inspector Demands:** The speaker provided specific examples of unpredictable FDA inspector behaviors: * An inspector arriving on a Tuesday afternoon and demanding the entire eTMF on a thumb drive by 9 AM the next morning. * Another inspector emailing a list of requested documents a week in advance but then reviewing only 25% of that list upon arrival, spending the majority of time on unrequested items. These examples underscore the need for constant, comprehensive TMF readiness.
Voice Assistant to control Veeva CRM
Peter Yeung
/@PeterYeung
Sep 16, 2017
This video provides a practical demonstration of integrating a consumer-grade voice assistant, specifically Amazon's Alexa, with Veeva CRM to enable hands-free control and data retrieval for pharmaceutical field representatives. The core purpose of the demonstration is to showcase how natural language processing (NLP) and voice commands can streamline administrative tasks within a critical enterprise system, thereby enhancing the productivity and efficiency of commercial operations personnel. The speaker uses a conversational interface to execute several common tasks required by a sales representative (rep) or medical science liaison (MSL), illustrating a significant shift from traditional screen-based interaction to an intuitive, voice-driven workflow. The demonstration begins with a basic command, "Alexa, what's wrong," which initiates the custom Veeva skill. The assistant immediately responds with a personalized greeting and prompts the user for a specific action. The first key action is an account lookup for "Clinton Ackerman." The voice assistant successfully identifies the account, retrieves key demographic and professional data—such as the specialty ("general practice")—and offers the user two immediate follow-up actions: requesting an account summary or creating a call. Opting for the summary, the user receives details including the preferred address ("967 Mill Brook Road Newton"), historical engagement data ("made two calls against this HCP this year"), and targeting status ("this account is not a target"). This sequence highlights the assistant’s ability to access and synthesize structured data from the CRM in real-time. A significant portion of the demonstration focuses on the creation of new call records, a fundamental administrative task for field reps. The speaker illustrates the flexibility of the NLP engine by specifying dates and times in various formats. Examples include creating a call for "today at 4 p.m." and specifying a precise future date like "Wednesday, July 12th at 3 p.m." The system successfully parses these natural language inputs and confirms the action, including the discussion topic ("Maxo discuss account Henry Allen"). This ability to handle complex, unstructured time and date inputs dramatically reduces the friction associated with manual data entry, allowing reps to log activities immediately after an interaction without needing to navigate the CRM interface. The demonstration concludes with the creation of a future call on "next Wednesday," confirming the system's utility for scheduling and calendar management within the Veeva ecosystem. Key Takeaways: • **Voice-Enabled Field Force Efficiency:** Integrating voice assistants with Veeva CRM offers a substantial opportunity to reduce the administrative burden on pharmaceutical sales representatives, allowing them to log calls, retrieve account data, and schedule follow-ups instantly and hands-free, potentially improving data capture accuracy and timeliness. • **Real-Time Data Retrieval:** The voice assistant successfully queries and summarizes critical HCP data points, including specialty, preferred address, historical call volume, and targeting status, demonstrating the potential for immediate, context-aware decision support in the field. • **Advanced Natural Language Processing (NLP) Requirements:** The system requires robust NLP capabilities to accurately parse complex, unstructured commands, particularly for scheduling. The successful interpretation of relative dates ("today," "next Wednesday") and specific dates ("Wednesday, July 12th") is crucial for practical adoption in commercial operations. • **Focus on Core Commercial Operations Tasks:** The demonstrated capabilities—account lookup, account summary, and call creation—are the highest-frequency administrative tasks for field reps, making this integration a high-value target for automation and workflow optimization within the life sciences sector. • **Custom Skill Development for Regulated Platforms:** The integration necessitates the development of a custom skill or AI agent (like the one built using Amazon Alexa) that can securely interface with the Veeva API, ensuring that data transmission and storage adhere to regulatory requirements (e.g., GxP, 21 CFR Part 11 compliance for audit trails). • **Potential for Generative AI Sales Ops Assistants:** This voice interface serves as a foundational example of a Generative AI Sales Ops Assistant, moving beyond simple task execution to providing contextual information and suggesting next steps ("You can ask me for an account summary or create a call"). • **Immediate Post-Interaction Logging:** The ability to log a call immediately upon leaving an HCP's office using voice commands minimizes the time lag between the interaction and data entry, leading to higher quality, less generalized call notes and improved compliance documentation. • **Open-Source Integration Frameworks:** The video description points to a GitHub repository, suggesting that the underlying integration framework is accessible or based on open-source principles, which can accelerate development for custom solutions tailored to specific commercial team needs. Tools/Resources Mentioned: * Veeva CRM * Amazon Alexa (Voice Assistant Platform) * GitHub (Repository for the integration code) Key Concepts: * **Voice Assistant Integration:** The use of conversational AI technology (like Alexa or custom LLMs) to interact with enterprise software systems. * **HCP Account Summary:** The quick retrieval of essential data points (specialty, address, engagement history) necessary for a pharmaceutical representative to prepare for or document an interaction with a Healthcare Professional. * **Call Creation:** The process of logging a specific interaction with an HCP in Veeva CRM, including the date, time, and topic of discussion, which is mandatory for compliance and performance tracking.
Connect Dell Boomi to Veeva Vault
Peter Yeung
/@PeterYeung
Sep 15, 2017
This video provides a practical demonstration of how to integrate Dell Boomi with Veeva Vault, specifically addressing the challenge of connecting to Veeva Vault when a direct, pre-built connector is unavailable in Dell Boomi. The presenter walks through a step-by-step process of leveraging Dell Boomi's standard HTTP connector to interact with the Veeva Vault API. The core objective is to authenticate with Veeva Vault to obtain a session ID, and then use that session ID to perform a query against the documents object within Vault. This showcases a common scenario in enterprise integration where generic API connectivity is essential for connecting disparate systems, especially within regulated industries like life sciences. The demonstration begins by outlining the overall integration process, emphasizing the critical role of Veeva Vault's API documentation. The first major step involves authenticating to Veeva Vault to secure a session ID. This is achieved by making an HTTP POST request to a specific Vault API endpoint, passing the username and password. The video highlights Dell Boomi's capabilities for securely handling credentials, noting that passwords can be encrypted and configured as replacement variables, preventing hardcoding into the integration process. Upon a successful authentication response, the session ID is extracted from the JSON payload and stored as a dynamic document property within Dell Boomi for subsequent use. Following successful authentication, the video proceeds to demonstrate how to perform a query on Veeva Vault's documents object. This involves another HTTP POST operation, but this time, the previously obtained session ID is passed in the authorization header. The query itself, formulated in a VQL-like syntax ("select ID and name from documents"), is sent as part of the request body. A crucial detail highlighted is the need to explicitly set the 'Accept' header to 'application/json' and the 'Content-Type' header to 'application/x-www-form-urlencoded' for the query operation, as Dell Boomi's default settings might not be compatible with the Vault API's requirements. The video concludes by running the integration process in Dell Boomi's test mode, showing the successful retrieval of the session ID and then the JSON response containing the queried document data from Veeva Vault. Key Takeaways: * **Custom API Integration Necessity:** The video demonstrates that even when a direct connector for a specific enterprise application like Veeva Vault is not available in an Integration Platform as a Service (iPaaS) like Dell Boomi, robust integration can still be achieved by directly interacting with the application's API using standard HTTP connectors. * **Reliance on API Documentation:** Successful integration hinges on a thorough understanding of the target application's API documentation, specifically for authentication methods, endpoint URLs, required headers, and expected request/response formats (e.g., Veeva Vault API documentation). * **Secure Credential Management:** Dell Boomi provides mechanisms to securely handle sensitive information like usernames and passwords. Passwords can be encrypted and configured as replacement variables, preventing them from being hardcoded into integration processes and enhancing security. * **Multi-Step Integration Flows:** Complex integrations often require multiple sequential steps, such as authenticating to obtain a session token first, and then using that token in subsequent API calls for data retrieval or manipulation. Dell Boomi's process flow allows for this chaining of operations. * **HTTP Connector Configuration:** The standard HTTP connector in Dell Boomi is highly configurable. Users can specify URLs, set custom headers (e.g., 'Accept', 'Content-Type'), and define resource paths to precisely match API requirements. * **Handling API Responses:** Integrations must be able to parse and extract relevant information from API responses, typically in JSON format. The demonstration shows extracting a session ID from a JSON authentication response and storing it for later use. * **Explicit Header Setting:** A common pitfall in API integration is incorrect HTTP headers. The video highlights the importance of explicitly setting headers like 'Accept: application/json' and 'Content-Type: application/x-www-form-urlencoded' to ensure compatibility with the target API, as default settings might not always suffice. * **Querying Data from Veeva Vault:** The demonstration illustrates how to construct and execute a query against Veeva Vault's data objects (e.g., 'documents') using a VQL-like syntax within the API request body. * **Trial and Error in Development:** The presenter mentions discovering specific header requirements through "trial and error," underscoring that practical integration development often involves iterative testing and adjustment to meet API specifications. * **Value of iPaaS Platforms:** Dell Boomi, as an iPaaS, simplifies the orchestration of complex integration logic, credential management, and error handling, making it a powerful tool for connecting enterprise applications even without native connectors. Tools/Resources Mentioned: * **Dell Boomi:** An Integration Platform as a Service (iPaaS) used for building and managing integrations. * **Veeva Vault:** A cloud-based content and data management platform widely used in the life sciences industry. * **Veeva Vault API Documentation:** The official documentation detailing how to interact programmatically with Veeva Vault. * **HTTP Connector:** A generic connector within Dell Boomi used to make standard HTTP requests to web services and APIs. Key Concepts: * **API (Application Programming Interface):** A set of rules and protocols for building and interacting with software applications. The video focuses on interacting with the Veeva Vault REST API. * **Authentication:** The process of verifying the identity of a user or system. In this context, it involves sending credentials to Veeva Vault to obtain a session ID. * **Session ID:** A unique identifier issued by a server after successful authentication, used to maintain the user's session and authorize subsequent requests. * **JSON (JavaScript Object Notation):** A lightweight data-interchange format used for transmitting data between a server and web application, commonly used in REST APIs. * **Dynamic Document Property:** A feature in Dell Boomi that allows for storing and retrieving temporary data (like a session ID) during the execution of an integration process. * **Replacement Variable:** A mechanism in Dell Boomi to parameterize configurations, allowing values (like passwords) to be set dynamically or securely without hardcoding.
Intelligent Customer Engagement Powered by Veeva Commercial Cloud
Veeva Systems Inc
/@VeevaSystems
Sep 10, 2017
This video provides an in-depth exploration of how the Veeva Commercial Cloud enables intelligent, coordinated customer engagement within the rapidly evolving life sciences commercial landscape. The presenter establishes that the industry is facing digital disruption, a complicated customer network, and changing engagement models, necessitating new levels of efficiency, agility, and smarter interaction. The core strategy presented is to move the industry toward "more coordinated intelligent engagement" by leveraging the rich data captured daily across various channels to tailor interactions based on customer needs and consumption preferences. The Veeva Commercial Cloud is presented as the unified foundation for achieving this goal, structured into two primary components: the CRM Suite and Commercial Content. The CRM Suite focuses on customer engagement, ensuring the right customer data is utilized, resources are properly aligned, and touch points are planned and executed across multiple channels. This suite is designed to make commercial sales teams more productive and efficient. In parallel, the Commercial Content component focuses on optimizing the message delivered to the customer, ensuring content is created, approved, and distributed effectively and efficiently across both Veeva and non-Veeva channels. The presentation details the specific products comprising the CRM Suite, emphasizing their role in optimizing commercial operations from strategy to execution. These products address critical functions such as sales force automation (Multi-channel Veeva CRM), accurate customer and compliance data (Veeva Open Data, Veeva Network), resource allocation and territory management (Align), and regulatory-compliant event execution (Veeva Events Management). The Commercial Content foundation, based on Vault PromoMats, centers on digital asset management (DAM) to govern the complete content lifecycle—from creation and approval to distribution—enabling content sharing and reuse, which is cited as a potential source of millions of dollars in global content reduction. The video concludes by highlighting tangible benefits realized by companies leveraging the Commercial Cloud. These benefits center heavily on operational efficiency and commercial effectiveness. Specific metrics cited include a 90% reduction in the time required for a data change request (from weeks to hours), a slashing of territory alignment time from weeks to days (a 75% overall reduction), and a case study where a customer grew sales faster and outperformed a control group by 30% through the use of targeted insights and suggestions. This demonstrates that the Commercial Cloud is positioned not just as a technology platform, but as a driver of measurable ROI and competitive advantage in adapting to market changes while delivering superior customer experience. Key Takeaways: • **Strategic Shift to Intelligent Engagement:** The life sciences industry must move toward coordinated, intelligent engagement models that leverage rich, cross-channel data to tailor interactions to customer needs, moving beyond traditional sales models. • **Veeva Commercial Cloud Architecture:** The platform is fundamentally divided into the CRM Suite (focused on customer data, resource alignment, and execution) and Commercial Content (focused on message optimization, creation, and distribution). • **Operational Efficiency Gains are Significant:** Companies are realizing substantial reductions in critical back-office processes, including a 90% reduction in data change request time (from weeks to hours) and a 75% reduction in overall territory alignment time (from weeks to days). • **Data-Driven Sales Outperformance:** The use of targeted insights and suggestions derived from the Commercial Cloud can lead to measurable sales growth, evidenced by one customer outperforming a control group by 30%. • **CRM Suite Components for Productivity:** The CRM Suite includes Multi-channel Veeva CRM for sales team productivity, Veeva Open Data for accurate HCP/HCO affiliations and compliance data, and Veeva Network for ensuring accurate customer data distribution. • **Aligning Strategy and Execution:** Veeva Align is critical for bridging commercial strategy and execution, ensuring the correct allocation of resources to customers based on strategic priorities and data insights. • **Compliance in Events Management:** Veeva Events Management is specifically highlighted for enabling better events with greater compliance, addressing a key regulatory challenge in pharmaceutical commercial operations. • **Content Lifecycle Management (CLM) ROI:** Commercial Content, built on Vault PromoMats, emphasizes digital asset management (DAM) to manage the complete content lifecycle, enabling reuse and distribution that can potentially save millions of dollars globally. • **Foundation of Trust and Accuracy:** The platform is positioned as the "trusted foundation" for customer engagement, emphasizing the importance of accurate HCP/HCO data and compliance adherence in all commercial activities. Tools/Resources Mentioned: * Veeva Commercial Cloud * Veeva CRM Suite * Veeva Commercial Content * Multi-channel Veeva CRM * Veeva Open Data * Veeva Align * Veeva Events Management * Veeva Network * Vault PromoMats (Digital Asset Management foundation) Key Concepts: * **Intelligent Customer Engagement:** Tailoring interactions based on customer needs and preferred consumption methods, utilizing rich, cross-channel data captured daily. * **Digital Disruption:** The looming threat forcing life sciences companies to fundamentally evolve their go-to-market strategies and operational models. * **Commercial Content Lifecycle:** The complete process of creating, approving, distributing, and managing commercial assets, facilitated by Digital Asset Management (DAM) within Vault PromoMats. * **HCP/HCO Affiliations:** Accurate data regarding Healthcare Professionals and Healthcare Organizations, crucial for compliance and targeted engagement, provided by Veeva Open Data. Examples/Case Studies: * **Data Change Request Efficiency:** A 90% reduction in the time required to complete a data change request, moving the process from weeks down to hours. * **Territory Alignment Speed:** A 75% overall reduction in the time needed for territory alignments, shifting the process from weeks to days. * **Sales Performance Improvement:** One customer utilizing targeted insights and suggestions from the Commercial Cloud grew sales faster and outperformed a control group by 30%.
Veeva: The Biggest Vertical SaaS Success Story of All Time with Founder/CEO Peter Gassner
SaaStr AI
/@Saastr
Aug 30, 2017
This video features an insightful conversation with Peter Gassner, Founder & CEO of Veeva Systems, detailing the company's remarkable journey from a startup to a leading vertical SaaS provider in the life sciences industry. Gassner recounts Veeva's origins, its strategic evolution, and the core philosophies that underpinned its success. The discussion highlights how Veeva established itself as an "industry cloud" for life sciences, serving major pharmaceutical companies like Pfizer and Novartis by offering specialized cloud solutions that enhance efficiency and effectiveness in bringing medicine to people. Gassner explains Veeva's progression from its initial focus on Pharmaceutical CRM (Veeva CRM) to expanding into new product lines. Around 2010, the company launched Veeva Vault, a content management system that now accounts for a significant portion of its revenue. More recently, Veeva has ventured into data solutions, generating unique data essential for the life sciences sector. This multi-product strategy, according to Gassner, was a deliberate and challenging pivot from being a single-product company, requiring a clear vision for new markets that were potentially larger than the initial offering. He emphasizes the importance of identifying "clear markets" even if their "correctness" isn't immediately apparent. Throughout the interview, Gassner shares his unconventional approach to entrepreneurship, characterized by a willingness to "not follow the herd." He describes how Veeva maintained extreme capital efficiency, burning only $3 million in its early days despite pressure to spend more. This frugality was coupled with a strong belief in value-based pricing, refusing to give away professional services because, as he states, if their people aren't worth paying for, they aren't worth anything. Gassner also delves into the critical role of execution, cultural development around "engaged teams working together," and the continuous pursuit of long-term, high-value relationships with customers in a highly regulated and impactful industry. Key Takeaways: * **Embrace Vertical SaaS:** Veeva's success stems from its "pin-prick" focus on the life sciences industry, demonstrating that deep specialization in a niche market can lead to immense value and growth, contrary to conventional wisdom about broad market appeal. * **Strategic Multi-Product Expansion:** Companies should consider new product lines that are potentially *bigger* than their initial offering, rather than just adjacent add-ons. This requires breaking apart product and company processes, a challenging but necessary step for significant scale. * **Extreme Capital Efficiency:** Veeva burned only $3 million early on, resisting pressure to overspend. Scarcity of capital, when managed intentionally, can foster discipline and focus on building a profitable business within existing resources. * **Value-Based Pricing & No Free Services:** Peter Gassner advocates for setting a clear, high value for products and services. Professional services should be profitable; if customers aren't willing to pay, it indicates a lack of perceived value or an issue with the service offering itself. * **Long-Term Customer Relationships:** In industries like life sciences, where software decisions are significant bets for customers (e.g., $20M+ annual deals), fostering 20-year relationships built on trust and consistent value is paramount. * **Execution Matters Most:** While ideas are important, Gassner stresses that 90% of his time is spent on execution. Good ideas get copied, but strong, consistent execution is enduring and ultimately differentiates a company. * **The "Adjacent Possible" for Innovation:** To avoid myopia, leaders should regularly engage with people outside their daily routine but in "adjacent" fields (e.g., banking, hospitals, medical devices, physics). This cross-pollination of ideas can spark unexpected breakthroughs. * **Phased Planning Approach:** In early startup phases, focus on quarterly plans (e.g., "let's not go out of business this quarter"). As the company matures, gradually extend to annual, three-year, and then vaguer five-year plans, adapting as stability increases. * **Cultivate "Engaged Teams Working Together":** Beyond Dunbar's number (150-200 people), fostering a culture where managers trust other teams and manage their own, rather than viewing teams as silos, is crucial for scaling and cohesion. * **Strategic "Undercovering" on Sales:** To maintain high customer satisfaction and long-term relationships, avoid over-covering with sales representatives. Sacrificing short-term top-line revenue prevents desperate sales tactics that can damage customer trust. * **Product Development as a Long-Term Investment:** Product development is likened to a "four-year cooking cycle." Hiring product people now is an investment for revenue and impact several years down the line. * **Mission-Driven Evolution:** While initial missions might be survival, companies can grow into a larger, more impactful mission over time. Veeva's mission evolved from "not going out of business" to "making life sciences more efficient" and improving patient outcomes. * **"Good Enough Is Not Good Enough":** This mantra from Gassner's father emphasizes a commitment to excellence and continuous improvement, pushing teams beyond mere adequacy. **Tools/Resources Mentioned:** * **Orwick:** An internal application developed by Veeva to foster "engaged teams working together" and clarify roles and responsibilities within the scaling organization. **Key Concepts:** * **Industry Cloud:** A specialized cloud platform tailored to the unique needs and regulatory requirements of a specific industry, such as life sciences. * **Adjacent Possible:** A concept referring to the idea of exploring opportunities and innovations that are just beyond the current boundaries of one's field, often by drawing inspiration from related but distinct areas. * **Undercover on Reps:** A sales strategy where a company intentionally hires fewer sales representatives than the market could potentially support, sacrificing some short-term revenue to ensure reps are not desperate and can focus on building long-term customer relationships and value.
Veeva Systems CEO: Going For Quality? | Mad Money | CNBC
CNBC
/@CNBC
Aug 29, 2017
This video provides an in-depth exploration of Veeva Systems' business strategy, financial performance, and future prospects, featuring an exclusive interview with its founder and CEO, Peter Gassner, on CNBC's Mad Money. The segment begins by addressing the market's seemingly harsh reaction to Veeva's recent earnings report, where the stock dropped despite beating analyst expectations for earnings and revenue, and raising full-year forecasts. Jim Cramer, the host, expresses confusion over this "clobbering," setting the stage for Gassner to clarify the company's long-term vision and operational strengths. Gassner emphasizes Veeva's consistent focus on long-term fundamentals, highlighting the company's track record of growing both its top and bottom lines every quarter since going public. He attributes the stock's volatility to its significant run-up prior to the earnings report and potentially "spoiled" investor expectations. The discussion then shifts to Veeva's core offerings within the life sciences industry, which include cloud-based software to enhance pharmaceutical sales rep effectiveness, capture clinical trial data, and ensure regulatory compliance. Gassner details how Veeva's integrated cloud platform, encompassing products across clinical, quality, regulatory, and commercial areas, provides a unique and cohesive solution that customers highly value, differentiating them from competitors like Medidata in clinical or IMS in broader data. A significant portion of the interview is dedicated to Veeva's strategic expansion beyond its traditional life sciences market. Gassner introduces "QualityOne," a product designed to manage quality processes, which is gaining traction in adjacent industries such as cosmetics, chemical, food, and industrial manufacturing. He explains that these sectors, much like pharma, require rigorous quality management and, critically, need cloud-based systems to effectively involve their suppliers in these processes. This expansion is framed as a natural extension of Veeva's expertise in health and human safety, brand reputation, and regulatory adherence, mirroring the successful market expansion seen with companies like ServiceNow in IT operations. Gassner concludes by reiterating Veeva's ambition to become one of the few multi-billion dollar profitable cloud companies, driven by hard work and a clear, targeted strategy. Key Takeaways: * **Long-Term Fundamentals Over Short-Term Volatility:** Veeva's CEO, Peter Gassner, stresses that the company prioritizes consistent growth in top and bottom lines every quarter, a strategy that has been successful since its IPO. Investors should look beyond short-term stock fluctuations, which can be influenced by prior stock performance or elevated expectations, and focus on the underlying business health. * **Integrated Cloud Platform as a Core Differentiator:** Veeva's strength lies in offering multiple products across clinical, quality, regulatory, and commercial areas, all unified on a single cloud platform. This integration simplifies operations and provides a cohesive experience for life sciences customers, a key competitive advantage against more siloed solutions. * **Strategic Expansion into Adjacent Industries:** Veeva is successfully leveraging its "QualityOne" product to enter new markets beyond life sciences, including cosmetics, chemical, food, and industrial manufacturing. This demonstrates a repeatable growth model based on applying proven software solutions to industries with similar needs for quality processes and regulatory compliance. * **Addressing Underserved Cloud Markets:** The expansion strategy for QualityOne is driven by identifying "underserved markets" that have a significant pent-up demand for cloud-based solutions, particularly for managing quality processes that require seamless supplier involvement. This approach mirrors the successful market penetration strategies of other cloud giants like ServiceNow. * **Importance of Regulatory Compliance and Quality Processes:** The video underscores the critical need for robust quality processes and regulatory compliance across various industries, not just life sciences. Veeva's solutions address both health and human safety concerns and the protection of brand reputation, which are paramount for manufacturers. * **The "Veeva Way" of Product Development and Market Entry:** Veeva's methodology involves creating a high-quality product for a targeted area, securing early customers, ensuring their success, continuously improving the product, and then leveraging reference selling for broader adoption. This systematic approach facilitates effective market penetration and expansion. * **Cloud-Based Systems for Supplier Collaboration:** A crucial driver for the adoption of Veeva's QualityOne in new industries is the necessity for manufacturers to involve their suppliers in quality processes. Only true cloud-based systems can facilitate this level of collaboration, highlighting a significant market gap Veeva is filling. * **Ambitious Long-Term Vision:** Peter Gassner articulates a clear ambition for Veeva to become one of the few multi-billion dollar profitable cloud companies over time. This vision is grounded in consistent execution, strategic product development, and targeted market expansion. Tools/Resources Mentioned: * **Veeva CRM:** A leading platform in the pharmaceutical industry for customer relationship management. * **Veeva QualityOne:** A product specifically designed for managing quality processes, now expanding beyond life sciences. * **Medidata:** Mentioned as a competitor in the clinical area. * **IMS (IQVIA):** Mentioned as a competitor in broader data and market intelligence. * **ServiceNow:** Referenced as an example of a company that successfully expanded its cloud solution to a large, underserved market (IT operations). Key Concepts: * **Cloud-based software:** Software delivered over the internet, accessible from any device, central to Veeva's offerings. * **Multi-billion dollar profitable cloud companies:** Veeva's aspirational goal, emphasizing both scale and profitability in the cloud sector. * **The "Veeva Way":** A systematic approach to product development, customer acquisition, and market expansion based on quality, customer satisfaction, and reference selling. * **Health and human safety / Brand reputation:** Key drivers for the adoption of quality management software in regulated industries. Examples/Case Studies: * **Expansion into Chemical, Cosmetics, Food, and Industrial Manufacturing:** Veeva's QualityOne product is gaining traction in these sectors, demonstrating the applicability of their quality management solutions beyond traditional life sciences. * **ServiceNow Comparison:** The expansion of QualityOne is likened to ServiceNow's success in bringing cloud solutions to IT operations, highlighting a similar strategy of identifying and serving a large, underserved market with cloud technology.
MasterControl eTMF Manager
MasterControl
/@MasterControlVideo
Aug 29, 2017
This video provides a detailed overview of the MasterControl eTMF Manager, a specialized software solution designed to streamline the management of the electronic Trial Master File (eTMF) throughout the clinical trial lifecycle. The primary context established is the common, costly mistake organizations make by implementing disparate, disconnected applications to handle various aspects of their clinical trials. MasterControl positions its eTMF Manager as a unified, integrated platform capable of managing all TMF documentation, related processes, tasks, and milestones within a single system, thereby improving efficiency, collaboration, and transparency for sponsors, CROs, and clinical study sites. The core functionality of the eTMF Manager is built upon the industry-standard DIA TMF Reference Model structure. This framework serves as a foundational template and checklist for every new study, ensuring that all necessary study artifacts and tasks are accounted for from the outset. The system is designed with various clinical research roles in mind—including clinical directors, clinical research associates, and principal investigators—to facilitate the planning, assigning, creating, reviewing, and approving of the hundreds of TMF artifacts generated throughout a study’s duration. A critical component highlighted is the automated document routing and approval capabilities, which are essential for maintaining regulatory adherence. A significant emphasis is placed on regulatory compliance, specifically mentioning that the solution ensures electronic signatures and audit trails are maintained in strict accordance with 21 CFR Part 11 requirements. Operationally, the eTMF Manager provides configurable TMF views that can be filtered by status and assignments, offering real-time visibility into clinical study activities. Each TMF artifact within the system includes configurable attributes—such as name, taxonomy, default document type, and custom fields—which control the document's lifecycle, authorization templates, and workflow routes. This level of customization and control ensures that both internal users and external parties (like CROs and site users) can efficiently manage their assigned tasks, upload or create documents, and proceed through predefined workflow routes, ultimately bringing all TMF documentation and operations together under a unified platform. Key Takeaways: • **Unified Clinical Management Platform:** The primary value proposition is solving the problem of disconnected applications by offering a single, integrated platform for TMF documentation, tasks, milestones, and related processes, which is crucial for reducing administrative overhead and improving data integrity. • **DIA TMF Reference Model Foundation:** The system utilizes the DIA TMF Reference Model as a standardized template for launching new TMF projects, ensuring comprehensive coverage and serving as an outline and checklist for all required study artifacts and tasks. • **Regulatory Compliance (21 CFR Part 11):** The platform is explicitly designed to meet stringent regulatory requirements by automating document routing, approval workflows, and maintaining robust electronic signatures and immutable audit trails, which is non-negotiable for FDA-regulated clinical data. • **Role-Based Efficiency:** The solution caters specifically to key clinical research roles (Clinical Directors, CRAs, PIs) by streamlining processes, tasks, and document management generated before, during, and after a clinical trial, enhancing collaboration across the ecosystem. • **Real-Time Visibility and Tracking:** The eTMF Manager provides TMF views that can be filtered by status and assignments, offering sponsors and CROs real-time visibility into the progress of pending, ongoing, and completed actions across all clinical study activities. • **Configurable Artifact Management:** TMF artifacts are highly configurable, allowing organizations to define artifact names, taxonomy, default document types, and custom fields, which in turn control the default rights, lifecycle, and document authorizing templates for precise control over data governance. • **External User Collaboration:** The system supports setting TMF artifact assignments for users both internal and external to the organization (e.g., CROs and site personnel), facilitating seamless collaboration and ensuring all parties are notified of and can execute their assigned tasks within the regulated environment. • **Automated Workflow and Completion:** Users are notified of task assignments and can proceed through predefined workflow routes for uploading, creating, reviewing, and approving TMF artifacts; upon completion, the content automatically appears in the TMF management view as complete, minimizing manual status updates. Tools/Resources Mentioned: * MasterControl eTMF Manager * MasterControl Clinical Excellence™ (suite of products) Key Concepts: * **eTMF (Electronic Trial Master File):** The digital repository for essential documents and records related to a clinical trial, necessary for reconstruction, management, and inspection of the trial. * **DIA TMF Reference Model:** A standardized, structured model for organizing and filing TMF documents, widely adopted in the pharmaceutical industry to ensure consistency and completeness. * **21 CFR Part 11:** The FDA regulation governing the use of electronic records and electronic signatures, requiring systems to ensure trustworthiness, reliability, and equivalence to paper records and handwritten signatures. * **CROs (Contract Research Organizations):** Third-party organizations that manage clinical trials and research activities on behalf of pharmaceutical or biotech sponsors.
Fireside Chat with Alex Azar and Matt Wallach
Veeva Systems Inc
@VeevaSystems
Aug 24, 2017
This fireside chat, featuring Alex Azar (former US President of Eli Lilly and former Deputy Secretary of HHS) and Matt Wallach (Veeva Systems Inc.), provides an in-depth discussion on the major commercial, operational, and regulatory trends impacting the pharmaceutical and life sciences industries. The conversation centers on the evolving role of the pharmaceutical sales representative, the necessity of integrated customer engagement strategies, the organizational shift toward Key Account Management (KAM), and the critical need for digital transformation in content management and regulatory approval processes. The speakers leverage their extensive experience in both commercial leadership and government regulation to offer a unique, actionable perspective on optimizing pharma commercial models in a digitally disrupted and highly regulated environment. A central theme addressed is the "death of the pharmaceutical sales rep," which Azar argues is "greatly exaggerated." While acknowledging the continuous decline in access to physicians, he maintains that the sales rep remains the highest ROI tactic for many brands, emphasizing that the personal relationship is still the foundational linchpin for building other capabilities. However, this reliance on the rep must be supplemented by sophisticated digital engagement. Azar shared a specific experiment where his team targeted "white space" physicians (those never called upon by a rep) who were in the lowest tier of brand advocates. By employing a 360-degree interaction package—including peer-to-peer videos on platforms like Medscape and WebMD, direct mail, and email—they were able to convert 18% of these physicians to the top tier of advocacy within six months. This demonstrates that while digital engagement is highly effective, its maximum potential is realized when integrated *around* the foundational rep relationship, rather than replacing it. The discussion then pivots to the organizational challenge of implementing Key Account Management (KAM). Azar differentiates between behavioral KAM (which he believes all effective sales professionals already practice by building long-term, value-adding relationships) and organizational KAM. He described a successful organizational structure modeled after the US military's approach to a theater of operations. In this model, a dedicated major account leader is placed in charge of a geographic or system "theater," pulling together various functional strands. This team included sales reps, dedicated medical staffing for appropriate interactions, and payer major account personnel, all focused on the customer's needs rather than internal brand silos. This integrated approach dramatically increased internal engagement and external customer satisfaction, as the company organized itself around the customer system. Finally, the conversation tackles the major impediment to digital competitive advantage: regulatory processes and content management. Azar identifies the industry’s inherent risk aversion and outdated compliance systems as the bottleneck, noting that the speed at which companies can analyze content consumption and distribute compliant materials is crucial. He specifically highlighted the pain point of modifying digital materials through legacy, paper-based approval processes, where the slightest change necessitates a complete rework. He praised the transition to Veeva Vaults, noting that it improved compliance, provided a better system of record, and significantly boosted the engagement and satisfaction of the marketing, regulatory, medical, and legal teams involved in the material approval process. The chat concludes on a highly optimistic note regarding the current golden age of pharmaceutical innovation driven by genomics and molecular understanding of disease. Key Takeaways: • **The Sales Rep is Not Dead, But Evolving:** The pharmaceutical sales representative remains the highest ROI commercial tactic; however, declining access necessitates supplementing the rep relationship with robust digital engagement strategies. • **Digital Engagement Maximizes Rep ROI:** Digital interactions (e.g., peer-to-peer videos, targeted email, direct mail) are highly effective in converting low-tier or "white space" physicians, but they function optimally when integrated as a 360-degree package built around the core rep relationship. • **Quantifiable Digital Conversion:** A specific case study showed that a multi-channel digital engagement strategy, targeting physicians who had never seen a rep, successfully converted 18% of the lowest-tier advocates to the highest tier within six months. • **Key Account Management (KAM) Requires Organizational Restructuring:** Effective KAM goes beyond behavioral selling; it requires an integrated organizational structure where a major account leader commands a cross-functional team (sales, medical, payer relations) focused on the customer system, mirroring a military theater command model. • **Integrated Teams Boost Engagement and Satisfaction:** Implementing an organizational KAM structure, where teams are organized around the patient and customer rather than internal brand silos, dramatically increases internal employee engagement and external customer satisfaction. • **Regulatory Processes Impede Digital Competitive Advantage:** The single biggest impediment to leveraging digital content and speed is the risk-averse nature of the regulatory approval process, particularly the use of paper-based workflows for modifying digital materials. • **Need for Digital Regulatory Transformation:** Companies must transition away from legacy content approval systems that require complete rework for minor digital changes, adopting modern platforms that streamline compliance and provide a robust system of record. • **Veeva Vaults as a Compliance Solution:** The adoption of modern systems like Veeva Vaults was cited as a successful transition that improved compliance, enhanced the system of record, and significantly increased the satisfaction of regulatory, medical, and marketing teams. • **Focus on Customer-Centric Planning:** Successful KAM involves sitting down with the customer system and conducting mutual account planning to determine what the customer needs from the pharmaceutical partner, rather than organizing solely around the company’s internal needs. • **The Golden Age of Pharma Innovation:** The industry is entering a revolutionary period driven by the fruits of the human genome project, enhanced understanding of molecular disease, and the ability to custom-design molecules, shifting the focus from "will it work?" to "does it work without off-target effects?" Tools/Resources Mentioned: * **Veeva Vaults:** Mentioned as a solution for content management, regulatory approval, and compliance tracking. * **Medscape:** Cited as a platform used for distributing peer-to-peer videos to physicians. * **WebMD:** Cited as a platform used for distributing peer-to-peer videos to physicians. Key Concepts: * **White Space Physicians:** Physicians who have never been engaged or called upon by a company's sales representatives. * **360-Degree Interaction Package:** A comprehensive, multi-channel approach to customer engagement that integrates various digital and traditional tactics (email, direct mail, videos, rep visits) to surround the customer. * **Organizational Key Account Management (KAM):** A structural approach where cross-functional teams (sales, medical, payer) are led by a single account commander and organized specifically around the needs of a major integrated health system or customer entity.
Executive Spotlight: A Conversation with Alex Azar
Veeva Systems Inc
@VeevaSystems
Aug 24, 2017
This executive spotlight features a conversation with Alex Azar, former President of Lilly USA and former Deputy Secretary of the U.S. Department of Health and Human Services (HHS), focusing on the profound shifts impacting pharmaceutical commercial operations, particularly concerning specialty medicines and the evolving payer landscape. The discussion establishes that the rise of targeted, often higher-cost injectable specialty medicines is fundamentally changing the demands placed on pharmaceutical sales representatives and medical teams. Azar argues that this shift necessitates a move away from traditional product selling toward a sophisticated, account-based selling model, emphasizing Key Account Management (KAM). The core transformation identified is the elevation of the sales professional's role from a mere conveyor of efficacy and side-effect information to a "broker of capabilities." Due to the complexity of specialty products, sales reps must now be deeply conversant in a wide suite of non-clinical issues critical to the physician's practice, office staff, and patients. These essential capabilities include reimbursement navigation, copay support, patient support programs, hub services, and adherence programs. Azar strongly refutes the notion of the "death of the sales rep," asserting that the human relationship remains the critical lynchpin of trust. However, he stresses that this human element must be supported by a robust technological ecosystem—a "360 platform"—that provides the necessary services and education, or acts as a substitute in low-access environments. Azar posits that the truly effective sales professional of the future will function much more like a Major Account Manager, viewing the doctor’s office or the integrated health system as an account to be serviced and advanced. In this new paradigm, the "selling aspect" is significantly diminished, replaced by the functions of educating, challenging, and serving as a comprehensive resource. While technology and multi-channel marketing are acknowledged as major trends, Azar identifies the single biggest, most lasting impact on the pharma industry as the revolution in payer power and control. The final segment of the conversation focuses entirely on the unprecedented control exerted by large payers and Pharmacy Benefit Managers (PBMs). Azar notes that over the last five years, payers have demonstrated an undeniable ability to control and move market share, prefer drugs, and place products in non-formulary status without experiencing significant customer leakage. He cites the CVS deal approximately six years prior, which locked down the national formulary, as a pivotal moment that disproved the long-held industry belief that large employers would resist formulary disruption for their employees. Consequently, the primary struggle for pharmaceutical companies is shifting from gaining market share to preserving "gross-to-net" profitability to sustain the flow of innovation. Key Takeaways: • **Evolving Role of the Sales Professional:** The specialty medicine landscape requires sales reps to transition from focusing solely on clinical data (efficacy, side effects) to mastering a complex suite of non-clinical support services essential for the physician's practice and patients. • **The Sales Rep as a "Broker of Capabilities":** Modern pharma reps must be experts in reimbursement, copay support, patient support programs, hub services, and adherence programs, acting as the face and entry point for the company's massive global resources. • **Shift to Key Account Management (KAM):** The future of pharmaceutical commercial engagement lies in treating the physician's office or integrated health system as a major account that requires continuous servicing, education, and resource provision, rather than transactional selling. • **Technology as an Essential Enabler:** While the human relationship remains vital, it must be supported by a comprehensive "360 platform" of technology, services, and education; this platform is necessary to empower the rep or to serve as an alternative channel where physical access is limited. • **Payer Power is the Dominant Industry Trend:** The single most impactful trend affecting the pharmaceutical industry is the revolutionary increase in payer power, control, and ability to manage formularies and market share without significant customer disruption. • **Gross-to-Net Preservation is the New Battleground:** The primary challenge for pharmaceutical companies is shifting from the traditional goal of gaining market share to the critical need to preserve gross-to-net revenue to ensure product profitability and sustain future R&D innovation. • **Disproving the Customer Leakage Myth:** Historical assumptions that large employers would prevent PBMs from aggressively controlling formularies (due to fear of employee disruption) were disproven by major industry events, such as the CVS national formulary lockdown. • **Consumer Willingness to Accept Restriction:** In individual and Part D markets, consumers have demonstrated a willingness to accept lower premiums in exchange for plans that feature higher control and more limited formularies, further empowering payers. Key Concepts: * **Specialty Medicines:** Typically defined as higher-cost, often injectable products that target specific molecular validated targets, requiring specialized handling, administration, and patient support. * **Key Account Management (KAM):** A strategic approach where the pharmaceutical company focuses on developing deep, long-term relationships with key customers (e.g., large integrated health systems, major physician groups) viewed as accounts to be serviced and advanced. * **Gross-to-Net:** The difference between a drug's list price (gross) and the actual revenue received by the manufacturer after accounting for rebates, discounts, fees, and other price concessions (net). * **Payer Power:** The increasing ability of insurance companies, PBMs, and government programs (like Medicare Part D) to control market access, formulary placement, and pricing leverage over pharmaceutical products.
Executive Spotlight: A Conversation with Peter Gassner
Veeva Systems Inc
/@VeevaSystems
Aug 24, 2017
This video provides an in-depth conversation with Peter Gassner, CEO of Veeva Systems, focusing on the state and future trajectory of digital transformation within the life sciences industry. Gassner asserts that while digital disruption has fundamentally transformed sectors like travel (Uber, Airbnb) and retail (Amazon), it is only just beginning to take hold in life sciences due to the unique complexities surrounding human health, safety, regulatory environments, and intellectual property. He posits that this transformation, when fully realized, will significantly improve efficiency and ease of access for the end customers: patients, clinical investigators, and prescribing physicians. Gassner identifies a crucial turning point in the industry's digital maturity: the realization that successful digital disruption requires collective effort and collaboration. He cites the formation of industry groups like TransCelerate on the R&D side and Align Biopharma on the commercial side as evidence that the life sciences sector is beginning to standardize processes and technologies. Specifically regarding customer engagement, Veeva is focused on transforming interactions in a digital sense by enabling clinical investigators and physicians to access necessary information in a standard format, eliminating the need for multiple logins and disparate systems across different pharmaceutical companies. Align Biopharma is the technical standards body driving this standardization, allowing technology providers like Veeva to build conforming products that unify the industry experience. Looking toward the next frontier, Gassner highlights Veeva’s expanding focus beyond commercial operations into the R&D side of life sciences. Major areas of product progress include quality and manufacturing, regulatory affairs, and the clinical domain. A significant goal in clinical operations is the transformation of the process by eliminating paper, thereby accelerating the speed of clinical trial development—a critical bottleneck in drug development. Furthermore, Gassner elaborates on the value proposition of machine learning (ML) and data science. Veeva is making tremendous investment in this area, aiming to aggregate and analyze the vast amounts of usage data generated by hundreds of thousands of users across all their applications. This centralized data science effort is intended to provide fundamental insights and reporting back to the industry, making ML and data science core to Veeva’s future strategy. In closing, Gassner offers strategic advice to CEOs of pharmaceutical companies. He urges them to view technology primarily through the lens of employee engagement, recognizing that their people are their most important asset. Secondly, he stresses the necessity of industry partnerships to solve digital engagement and disruption challenges. He reminds CEOs that they share customers (e.g., Pfizer shares customers with Lilly and Merck) and must collaborate to enable a unified, efficient digital experience for those shared customers. --- ### Key Takeaways: * **Digital Disruption is Nascent in Life Sciences:** Unlike other major industries, digital transformation is still in its early stages in the life sciences sector, primarily due to stringent regulatory requirements, safety concerns, and complex intellectual property issues. * **Collaboration is the Prerequisite for Transformation:** The industry has passed a major hurdle by realizing that digital disruption can only be achieved through collective standardization and cooperation. This shift is exemplified by groups like TransCelerate (R&D focus) and Align Biopharma (Commercial focus). * **Standardization Drives Commercial Efficiency:** The goal of commercial digital transformation is to simplify information access for healthcare professionals (HCPs) and clinical investigators. Standardization, facilitated by groups like Align Biopharma, eliminates fragmented digital experiences (e.g., needing different logins for every pharma company website). * **Veeva’s Strategic Expansion into R&D:** The next major frontier for Veeva involves significant product progress in the R&D domain, specifically targeting quality and manufacturing, regulatory processes, and transforming clinical operations. * **Eliminating Paper in Clinical Trials:** A key focus of R&D transformation is the digital overhaul of the clinical process to remove paper documentation, which is essential for accelerating the speed and efficiency of clinical trial development. * **Machine Learning as a Core Competency:** Data science and machine learning are becoming fundamental to Veeva’s strategy. The company is investing heavily to centralize and analyze usage data from its applications to generate actionable insights and reports for the industry. * **Technology Must Prioritize Employee Engagement:** CEOs in the life sciences industry should view technology investment primarily as a tool to enhance the engagement and effectiveness of their employees, who are the company’s most valuable asset. * **Embrace Shared Customer Responsibility:** Pharma CEOs must recognize that they have shared customers across competitors (e.g., Pfizer, Lilly, Merck). Industry partnerships are essential to collectively solve digital engagement challenges and provide a cohesive experience for these shared customers. * **Align Biopharma Focuses on Technical Standards:** Align Biopharma’s specific role is to create the technical standards that enable digital engagement, allowing software companies to build compliant products that ensure industry-wide interoperability and consistency. --- ### Tools/Resources Mentioned: * **Veeva Systems:** The core platform provider discussed throughout the interview, specializing in solutions for commercial, medical, quality, and R&D operations in life sciences. * **TransCelerate:** An industry collaboration group focused on accelerating R&D processes in life sciences. * **Align Biopharma:** A standards group focused on creating technical standards for commercial engagement in the biopharma industry. ### Key Concepts: * **Digital Disruption:** The transformation of business models and processes across an industry through the integration of digital technology, leading to significant changes in how services are delivered and consumed. * **Customer Engagement (Digital Sense):** The process of interacting with healthcare professionals, patients, and investigators through standardized, efficient digital channels, moving away from fragmented, company-specific systems. * **Clinical Process Transformation:** The effort to digitize and streamline clinical trial operations, specifically targeting the elimination of paper-based processes to increase speed and efficiency in drug development.
The Evolution of Intelligent Engagement
Veeva Systems Inc
@VeevaSystems
Aug 24, 2017
This video provides an in-depth exploration of the critical shift within pharmaceutical commercial operations from traditional multi-channel marketing to "Intelligent Engagement." The discussion, led by industry executives, establishes that the sheer volume of customer data has rendered human-only optimization impossible. A typical sales representative manages 150 to 200 customers, with each customer generating potentially dozens of data interactions daily. The core challenge is processing this massive data set, consolidating it, and optimizing interactions across various touchpoints to ensure the engagement feels customer-centric and coordinated. The progression toward intelligent engagement is defined by the necessity of sophisticated systems and machine learning capabilities. The speakers emphasize that customers—who are primarily focused on the patient or product—do not distinguish between internal departments (sales, medical affairs, etc.). Therefore, the company must present a fully integrated picture. The ideal engagement model is real-time, meeting the customer precisely when and how they want, ideally providing information just before the point of need, rather than adhering to a preordained schedule. This orchestration of different channels is identified as the crucial bridge between basic multi-channel delivery and true intelligent engagement. Intelligent engagement is fundamentally data-driven, relying on a 360-degree view of the customer. This comprehensive data set is combined with machine learning models to determine the "next best interaction" (NBI), the "next best piece of material," and the appropriate channel (e.g., digital versus face-to-face). However, the executives stress a critical prerequisite: the entire structure is worthless without clean, foundational master data. This includes accurate data on customers, products, sales, payers, and physicians. If the master data is not correctly set up, the effort spent on layering on aggregate data and sophisticated models will fail. The ultimate goal is to move beyond mere coordination to a predictive state, offering field representatives actionable insights on how to best interact with customers in a fashion coordinated across medical, patient services, and sales. Key Takeaways: * **Data Overload Necessitates Automation:** Sales representatives are overwhelmed by the volume of data; with 150-200 customers and dozens of daily data interactions per customer, systems and machines are required to process, consolidate, and optimize interaction strategies effectively. * **Intelligent Engagement Defined:** This concept moves beyond set-schedule, multi-channel delivery to a data-driven approach where machine learning determines the optimal time, channel, and content for engagement based on a comprehensive customer view. * **Orchestration is the Foundational Bridge:** The shift requires establishing ubiquitous orchestration capabilities across all regions and channels to coordinate interactions seamlessly, ensuring that the customer experience is unified regardless of the touchpoint. * **Customer-Centricity Requires Internal Integration:** Since customers view the company as a single entity, engagement must be fully integrated across all business units (sales, medical, patient services) to provide a cohesive, patient- or product-focused experience. * **Real-Time, Point-of-Need Delivery:** Effective engagement means moving away from pre-set marketing schedules to delivering information dynamically at the point of need, or ideally, anticipating that need just beforehand. * **Machine Learning Drives the Next Best Interaction (NBI):** Sophisticated models analyze the 360-degree customer profile to predict the most effective action, material, and channel, optimizing resource allocation between digital and face-to-face interactions. * **Master Data Quality is Non-Negotiable:** The success of any intelligent engagement initiative hinges on having clean, correctly structured foundational master data for customers, products, sales, payers, and physicians; without this, subsequent efforts on aggregate data and modeling are wasted. * **Achieving Predictive Capability is the Goal:** The highest level of maturity involves providing predictive insights and guidance directly to field representatives, empowering them to make better, coordinated decisions in real time. * **Cross-Functional Coordination is Essential:** Intelligent engagement requires the well-orchestrated interaction of the "triad" of stakeholders—Medical Affairs, Patient Services, and Sales—to ensure a consistent and optimized customer journey. * **Focus on Systemic Processing:** The human mind cannot optimize interactions across 200 customers and dozens of data points; the solution lies in leveraging technology to process and synthesize this information into actionable, consolidated insights for the field. Key Concepts: * **Intelligent Engagement:** A data-driven approach to customer interaction in the pharmaceutical industry that uses machine learning and real-time data orchestration to determine the optimal time, channel, and content for sales representatives and digital channels. * **Orchestration:** The process of coordinating all customer touchpoints (sales, digital, medical) in real time to ensure a seamless, non-duplicative, and highly relevant experience, serving as the necessary precursor to intelligent engagement. * **Next Best Interaction (NBI):** An output of machine learning models that suggests the most effective action a sales representative or system should take next, based on the customer’s historical data, current behavior, and overall profile. * **Master Data:** The core, clean, and accurate foundational data (e.g., customer identity, product definitions, payer information) required to support advanced analytics and modeling efforts.
The Changing Role of the Sales Rep
Veeva Systems Inc
@VeevaSystems
Aug 24, 2017
This video, produced by Veeva Systems, provides an in-depth exploration of the evolving role of the pharmaceutical sales representative, emphasizing the necessary integration of technology and digital strategy to support commercial operations in a highly regulated environment. The core message is that while the sales rep remains a critical part of the commercial ecosystem, their function is fundamentally shifting from being the sole source of information to becoming the crucial broker of access to the company's vast capabilities and data. The discussion highlights that modern reps are being asked to wear "many hats" while maintaining strict regulatory compliance. This operational complexity necessitates robust technological support, specifically mentioning the **Veeva platform**, to ensure that all required information is instantly available at the rep’s fingertips. This digital disruption is key, as it allows for the seamless integration of marketing, sales operations (Sales Ops), and the field sales force. The goal is to create a unified customer journey where interactions are consistent, whether they occur in person or through digital channels. A significant theme addressed is the departure from the historical model where face-to-face selling was the primary or exclusive channel. The speakers assert that today’s physicians do not look to the rep to be the *sole source* of their information, but rather the *sole source of their access* to information. The successful rep is the one who can provide this seamless access and transition into the role of a trusted advisor. This requires the rep to understand how their in-person conversation is intertwined with every other digital touchpoint the company has with the healthcare professional. Ultimately, the analysis frames the sales professional as the "broker of capabilities"—the human face and entry point for a massive, global pharmaceutical company. While the personal relationship remains important, the rep's effectiveness is increasingly supplemented by technology. The most successful professionals are those who can combine comfort with digital tools (facilitating access, using short video calls) with a deep, foundational understanding of the drugs, their mechanism of action, and the regulatory requirements governing their discussions. Key Takeaways: • **The Rep as the Broker of Access:** The fundamental change in the sales rep’s role is shifting from being the primary information source to becoming the critical access point that connects the physician to the pharmaceutical company’s massive amount of services, capabilities, and information. • **Technology as a Compliance Enabler:** Given the requirement for reps to operate in a "very compliant regulated way," technological platforms (like the Veeva platform) are essential tools for providing comprehensive information instantly and ensuring that all interactions adhere to necessary regulatory standards. • **Digital Integration is Mandatory:** Effective commercial strategy demands the integration of marketing, sales operations (Sales Ops), and the field sales force using digital technology to ensure consistency and efficiency across all commercial activities. • **Unified Customer Journey Across Channels:** The modern sales rep must understand that their conversations are interconnected with all digital touchpoints. Technology must enable the conversation to carry through seamlessly between in-person calls, digital interactions, and other channels. • **The Rise of the Blended Interaction Model:** While the face-to-face relationship remains valuable for building trust, the model is evolving. Physicians who are comfortable with technology (e.g., those who started medical school with an iPhone) are increasingly receptive to efficient digital interactions, such as 30-second video calls, supplementing traditional visits. • **Success Requires Dual Expertise:** The most successful future sales professionals are those who can seamlessly combine comfort and proficiency with digital technology (to facilitate access) with a deep, foundational understanding of the drugs and their mechanism of action. • **Sales Ops Drives Content Feedback Loops:** Digital systems facilitate a crucial feedback mechanism where content and items created by Sales Ops can be pushed to marketing, and the sales rep integrates into all three functions, optimizing content and strategy based on real-time field interactions. • **The Sales Rep as the Corporate Face:** The sales professional acts as the critical entry point and the human face representing the massive, global pharmaceutical organization to the physician’s office, channeling the company’s services and capabilities effectively. Tools/Resources Mentioned: * **Veeva platform:** Mentioned specifically as a critical tool for providing reps with the information necessary to operate in a compliant, regulated way. Key Concepts: * **Broker of Capabilities:** The modern sales rep’s function is to act as the intermediary who connects the physician to the vast resources, information, and services of the pharmaceutical company, rather than being the sole source of that information. * **Digital Disruption:** The use of digital technology to fundamentally change how marketing, sales operations, and field sales interact and integrate, leading to a unified, multi-channel customer experience.