veeva rim

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This.ai, and delves into the digital transformation occurring within the pharmaceutical and life sciences industries, particularly concerning clinical trials and operational efficiency. This video explores Veeva ($VEEV) as a leading cloud solution provider driving digitalization in the healthcare sector, specifically within the pharmaceutical and life sciences industries. The speaker discusses Veeva's financial performance and significant growth, highlighting its role in accelerating the shift towards digital, paperless, and patient-centric clinical trials. A major focus is placed on Veeva Vault Clinical applications and the groundbreaking Veeva e-consent, which enables electronic informed consent for clinical studies, streamlining processes and facilitating decentralized trials. The video emphasizes the vast market opportunity for digital healthcare solutions and the increasing adoption of cloud-based services accelerated by recent global events. Key Takeaways: * **Veeva's Central Role in Digital Healthcare:** Veeva is presented as a crucial cloud solution for healthcare, offering business consulting and training to major pharmaceutical clients like Merck, Moderna, and Eli Lilly, underscoring its deep integration into the industry. * **Pioneering Digital Consent and Decentralized Trials:** The introduction of Veeva e-consent marks a significant milestone, enabling the first fully digital, electronic informed consent in clinical trials. This innovation facilitates paperless, patient-centric studies and supports a "work from home study" model, allowing remote patient participation and real-time visibility for sponsors. * **Streamlining Clinical Operations:** Veeva Vault Clinical applications are highlighted for their ability to streamline global trial processes for Contract Research Organizations (CROs), enhancing efficiency, reducing administrative burden, and accelerating study execution. * **Massive Untapped Market Potential:** The digital healthcare community represents a substantial and growing total addressable market (TAM), estimated at over $12 billion. Veeva is positioned to capture a significant portion of this, with projections for substantial revenue growth across its diverse cloud services, including data cloud, patient data & analytics, and commercial cloud. * **Accelerated Digital Adoption Post-Pandemic:** The video notes that the pandemic has significantly accelerated the industry's move towards digital solutions, making cloud-based services essential for maintaining study timelines and improving overall trial execution. * **Focus on Efficiency and Patient Experience:** The core benefits of Veeva's innovations are increased efficiency, faster processes, reduced administrative tasks, and an improved patient experience by removing geographical and paper-based barriers in clinical research.

Episode 6: Data Managers: Driving the Future of Clinical Research

Dec 2, 2022

This video directly addresses the evolving landscape of clinical data management within the pharmaceutical industry, the strategic importance of data, and the increasing role of advanced technologies like AI/ML. This video explores the transformative journey of clinical data management, highlighting its shift from a back-office function to a strategic imperative driving the future of clinical research. Richard Young and Mayank Anand discuss how data professionals' roles are evolving in an era of decentralized data, emphasizing the critical need for data to optimize trial protocols, operations, and patient access to treatments. The conversation delves into GSK's innovative approach to data strategy and management, which integrates various data functions and prioritizes an enterprise mindset, stakeholder collaboration, and patient-centricity. A key theme is the operationalization of AI/ML in clinical research, moving beyond buzzwords to real-world applications, while also considering ethical implications and the need for continuous professional evolution. Key Takeaways: * **Strategic Elevation of Data Management:** Clinical data management is no longer a secondary function but is now "front and center" in optimizing clinical trials, requiring professionals to drive the future of research rather than just support it. * **AI/ML as an Operational Reality:** AI and Machine Learning are no longer just buzzwords but are becoming integral to clinical data management, offering significant opportunities for efficiency and transformation, necessitating discussions around ethical AI and regulatory alignment. * **Integrated Data Strategy for End-to-End Oversight:** Leading pharmaceutical companies like GSK are adopting a holistic "Data Strategy and Management" approach, consolidating functions such as data acquisition, medical coding, core data management, centralized monitoring, and data analytics to ensure comprehensive and strategic data oversight. * **Enterprise Mindset and Collaborative Innovation:** Successful data transformation requires an "enterprise mindset" that considers all stakeholders (clinical operations, biostats, pharmacovigilance, etc.) and fosters collective ownership, utilizing agile methodologies to accelerate delivery and manage complex interdependencies. * **"Total Experience" for Adoption and Impact:** Designing new technologies and processes with "Total Experience" (TX) in mind—encompassing change management, communication, and the impact on all end-users, including patients and investigators—is crucial for successful adoption and achieving desired outcomes. * **Evolving Role of Data Professionals:** The traditional "data manager" role is transforming into future-oriented positions like "data scientist" or "data engineer," emphasizing continuous learning and adaptation to new technologies, rather than fearing job displacement by AI. * **Challenges in Infrastructure and Data Democratization:** Significant industry challenges persist in modernizing legacy infrastructure and achieving broader data democratization, highlighting areas for future innovation and collaborative efforts to unlock the full potential of clinical data.

Ending the paper trail with REDCap: optimized workflows for screening, consenting, and compensating

Apr 11, 2020

This video explores the successful digital transformation of administrative workflows in clinical research at the MGH Martinos Center, specifically focusing on replacing paper-based processes with REDCap. Olivia Rowe, a Clinical Research Coordinator, details how her team optimized subject screening, consenting, and compensation by leveraging REDCap's capabilities. The presentation highlights the numerous inefficiencies and compliance risks associated with paper forms, such as space consumption, outdated information, HIPAA vulnerabilities, and lack of flexibility. The implemented REDCap solution introduces digital safety screening, dynamic branching logic for tailored questionnaires (e.g., pregnancy screening), real-time eligibility feedback for participants, digital sign-offs for MRI technicians, and an integrated subject payment system. This initiative aims to alleviate administrative burdens, enhance data accuracy, and significantly improve regulatory compliance through robust audit trails and streamlined processes. Key Takeaways: * **Digital Transformation in Clinical Research:** The video directly addresses the administrative burden and compliance risks of paper-based workflows in clinical research, demonstrating a clear need for digital solutions to optimize operations within the life sciences sector. * **Workflow Optimization and Automation:** REDCap is effectively utilized to streamline critical processes like subject screening, consent, and compensation, showcasing the value of automating traditionally manual tasks through digital forms with features like branching logic and real-time feedback. * **Enhanced Regulatory Compliance:** Moving to digital platforms like REDCap significantly improves HIPAA compliance, provides thorough audit trails, and simplifies IRB approval processes through templated amendments, aligning with the strict regulatory requirements (e.g.ai helps clients navigate. * **Improved Participant Experience and Data Quality:** Digital forms empower participants to provide documentation, receive immediate eligibility feedback, and ensure more accurate and relevant data collection, reducing administrative overhead for research staff and improving overall data integrity. * **Interoperability and Customization Potential:** The discussion touches upon the ability to integrate with EMRs (like Epic) and the customizability of REDCap forms, highlighting the flexibility required for diverse research needs and the potential for broader data engineering initiatives. * **Scalability through Data Dictionaries:** The concept of sharing forms via a "data dictionary" allows for efficient replication and customization of standardized questionnaires across different labs, reducing redundant effort in setting up digital tools and promoting best practices.

RegTalks about Regulatory Information Management Systems (RIMS)

Oct 1, 2021

This video directly addresses Regulatory Information Management Systems (RIMS) within the pharmaceutical and life sciences industries, a core area for companies seeking to optimize operations and maintain regulatory compliance. **Summary:** The "RegTalks" video, featuring Lidia Canovas from Asphalion and Frank Dickert from EXTEDO, provides an in-depth exploration of Regulatory Information Management Systems (RIMS) and their increasing importance in the pharmaceutical and life sciences sectors. The speakers define RIMS as comprehensive solutions for master product data management, regulatory activity tracking, and integrated document management, serving as a crucial "single source of truth." A central theme is the significant industry transition from xEVMPD to the complex ISO IDMP standard, which necessitates robust RIMS to handle increased data transmission and regulatory compliance. The discussion highlights how RIMS enhance operational efficiency by replacing fragmented manual systems, improve impact assessment capabilities, and are applicable across various regulated fields beyond human medicines, including animal health and medical devices. Furthermore, the video emphasizes that RIMS benefit a wide array of departments beyond regulatory affairs, such as quality, clinical, manufacturing, and supply chain, and stresses the indispensable role of experienced implementation partners in successfully deploying these complex systems. **Key Takeaways:** * **RIMS as a Foundational Compliance System:** Regulatory Information Management Systems (RIMS) are critical enterprise solutions for the life sciences, providing a "single source of truth" for master product data, regulatory activities, and integrated document management, essential for ensuring regulatory compliance and operational efficiency. * **IDMP Transition Drives RIMS Adoption:** The impending transition to the ISO IDMP standard is a major catalyst for RIMS implementation, as it significantly increases data complexity and submission requirements, necessitating sophisticated systems to manage and submit data effectively, often integrated with eCTD submissions. * **Broad Organizational Impact:** RIMS are not exclusive to regulatory affairs but serve a wide range of departments across a life sciences company, including quality, clinical, manufacturing, marketing, and supply chain, by providing centralized access to regulatory information, thereby improving cross-functional decision-making and impact assessment. * **Beyond Human Medicines:** The utility of RIMS extends beyond human pharmaceuticals to other regulated sectors such as animal health, consumer health, and medical devices (e.g., for IVDR/MDR compliance), indicating a broader market need for robust regulatory data management solutions. * **Criticality of Implementation Expertise:** Successful RIMS deployment, especially in the context of IDMP compliance, requires knowledgeable external implementation partners who can provide technical support, guide necessary process changes, and leverage deep industry experience to ensure optimal system configuration and user adoption.

End to End Regulatory Information Management Case Study of a Veeva RIM Implementation

Apr 19, 2023

This. The discussion covers critical aspects like harmonizing global regulatory processes, managing data migration and integration from legacy systems, ensuring compliance, and navigating large-scale enterprise software adoption within the life sciences industry. This video explores an end-to-end Veeva Regulatory Information Management (RIM) system implementation for a top 10 pharmaceutical company, transitioning from disparate legacy systems to a globally consistent solution. The speakers discuss the complexities of harmonizing processes and terminology across global teams managing regulatory, CMC, and safety submissions. The case study highlights a multi-year journey involving current state assessment, future state design, detailed requirements gathering, configuration, and phased rollout strategies. A key theme is the collaborative approach between the client, Astrix (the consulting firm), and Veeva, emphasizing strong program management, communication, and meticulous planning for process and data readiness, as well as user adoption in a highly regulated environment. Key Takeaways: * **Complex Global Harmonization:** Large pharmaceutical companies face significant challenges in harmonizing regulatory processes and terminology across global teams due to reliance on disparate legacy tools (spreadsheets, SharePoint, bespoke systems). * **Structured Multi-Workstream Approach:** Successful large-scale implementations require a highly structured approach with dedicated workstreams for different functional areas (e.g., CMC, Safety, Regulatory, Authoring, Archive, Labeling), ensuring focused effort and expertise. * **Criticality of Process & Data Readiness:** Meticulous assessment of current processes, definition of harmonized future states, alignment on terminology, and comprehensive data mapping, migration, and integration planning are fundamental to a successful RIM system rollout. * **Vendor Collaboration is Key:** Direct and continuous collaboration with the software vendor (Veeva) is crucial for understanding system capabilities, best practices, configuration options, and leveraging product roadmaps for future enhancements. * **Comprehensive Change Management & Adoption:** Effective user adoption plans, including stakeholder analysis, continuous communication (newsletters, intranet), and tailored training, are essential to manage the learning curve and ensure business continuity during phased rollouts. * **Navigating Implementation Hurdles:** Common challenges include managing team member bandwidth, coordinating global time zones, addressing workstream dependencies, and adapting to system changes while maintaining ongoing critical operations and submission deadlines. * **Phased Rollout Strategy:** An iterative, phased rollout, starting with core capabilities and gradually expanding scope based on system readiness, legacy constraints, and business continuity, is an effective strategy for managing large-scale enterprise software implementations.

What is a Clinical Trial Manager (CTM) | Salary, Degree Requirements & More

Aug 30, 2022

This video provides a comprehensive overview of the Clinical Trial Manager (CTM) role, detailing their responsibilities, necessary educational background, and salary expectations. The speaker emphasizes that CTMs are crucial for establishing productive vendor relationships, ensuring strict clinical trial compliance with federal and global regulations, and improving the overall efficiency and quality of clinical trial activities. Key duties include overseeing Contract Research Organizations (CROs), managing investigational product sites, participating in study startup, reviewing critical study documents, resolving operational issues, and meticulously preparing and adhering to budgets and timelines. The CTM role is described as a blend of business acumen and scientific understanding, often requiring prior experience as a Clinical Research Associate (CRA). Key Takeaways: * **Central Role in Clinical Operations:** The CTM is a pivotal figure in pharmaceutical and biotech companies, directly responsible for the oversight and successful execution of clinical studies, bridging scientific objectives with operational realities. * **Critical for Regulatory Compliance:** A primary responsibility of the CTM is to ensure clinical trial compliance with federal and global regulations, highlighting the high-stakes environment where regulatory adherence is paramount. * **Complex Vendor Management:** CTMs are deeply involved in managing relationships with various vendors, particularly CROs, requiring strong negotiation, oversight, and problem-solving skills to maintain study timelines and budgets. * **Operational Efficiency and Problem Solving:** The role demands proactive identification and swift resolution of operational challenges to enhance the efficiency, effectiveness, and quality of clinical trial activities, directly impacting study success. * **Data-Driven Decision Making:** The CTM's need to manage study progress, budgets, and timelines implies a reliance on robust data and analytics for informed decision-making and issue resolution.

Aquila University The eCTD Publishing Process

Jan 17, 2020

This video explores the intricate and often underestimated eCTD (Electronic Common Technical Document) publishing process, which is critical for regulatory submissions like NDAs to agencies such as the FDA. The speaker highlights the common misconception among sponsors regarding the time and resources required to convert years of clinical data into a compliant and reviewable eCTD, emphasizing that inadequate planning significantly increases project risk. The discussion details the essential components for eCTD creation, including specialized publishing systems, advanced PDF tools, eCTD validators, and a dedicated team of experienced regulatory operations publishers. The process is broken down into four major activities: lifecycle planning, document remediation, quality control, and project management, with remediation consuming the vast majority of the effort. Key Takeaways: * **Underestimated Complexity:** eCTD publishing is a highly complex, resource-intensive process, with sponsors frequently underestimating the 2,000 man-hours and minimum four months required for a typical 505 B1 NDA (100,000+ pages, 300+ documents). * **Critical Resource Requirements:** Successful eCTD publishing necessitates a robust technology stack (publishing system, advanced PDF tools, dual eCTD validators) and a skilled team comprising experienced manager-level and associate-level regulatory publishers. * **Remediation is King:** Document remediation, involving cleaning, formatting, bookmarking, and intricate linking of individual PDFs, accounts for approximately 70% of the total project time, underscoring its manual and meticulous nature. * **QC is Non-Negotiable:** Cutting corners on the 15% allocated for quality control introduces substantial risk of non-compliance, incorrect versions, broken links, or inconsistent content, which can severely impact reviewer satisfaction and approval chances. * **Operational Challenges:** Beyond document processing, significant challenges include managing large file transfers (often 10-20+ GB per submission, requiring multiple transfers) and ensuring seamless integration of new submissions with previous ones. * **Strategic Compliance:** Proper eCTD planning and execution are not just technical tasks but strategic imperatives that directly influence regulatory approval timelines and outcomes by ensuring a clear, consistent, and easily reviewable application for regulatory bodies.

IDMP in a capsule Tutorial

Mar 24, 2022

This. The emphasis on patient safety and pharmacovigilance further underscores its relevance to medical affairs and regulatory compliance departments within their target market. This tutorial provides a comprehensive overview of the Identification of Medicinal Products (IDMP) standards, highlighting their crucial role in ensuring global medication safety. It explains how the ISO IDMP standards, though inconsistently implemented, are designed to work throughout a medicinal product's life cycle, from development and production to utilization and outcome assessment. Through illustrative stories, the video demonstrates how IDMP helps prevent adverse drug events, facilitates safe substitutions across different countries, curbs falsified medicines, and enhances global pharmacovigilance. A central theme is the concept of Medicinal Product Dictionaries (MPDs) as national repositories for comprehensive product information, linked globally by the Pharmaceutical Product Identifier (PHP ID), enabling seamless data navigation and personalized patient care through integration with personal health data. Key Takeaways: * **Standardized Global Identification is Critical:** Inconsistent identification of medicinal products across countries poses significant patient safety risks. IDMP provides a standardized framework (substance, dose form, strength, medicinal product, package) to ensure globally unique identification, crucial for safe healthcare and preventing errors. * **Medicinal Product Dictionaries (MPDs) as Central Data Hubs:** MPDs are vital national repositories that consolidate comprehensive product information (regulatory, scientific, pricing, dosage guidance). These dictionaries are the foundation for all information needed by hospitals, doctors, and pharmacies for safe prescribing and dispensing, and are accessed through various healthcare IT systems. * **The PHP ID Enables Cross-Border Data Linkage:** The Pharmaceutical Product Identifier (PHP ID) is a critical global identifier that allows for the seamless navigation and comparison of equivalent medicinal products across different national MPDs. This capability is essential for facilitating safe substitutions for patients traveling internationally and for aggregating global pharmacovigilance data. * **IDMP Supports Personalized Patient Safety:** By integrating IDMP-compliant product data from MPDs with individual patient health data (e.g., International Patient Summary - IPS), intelligent applications can provide real-time, personalized alerts for allergies, intolerances, and potential drug-drug interactions, significantly enhancing medication safety at the point of care. * **Enhanced Global Pharmacovigilance:** IDMP-compliant reporting, which includes the PHP ID and other identifiers, streamlines the aggregation and analysis of adverse drug event data globally. This enables faster identification of safety patterns, quicker responses (e.g., product recalls, updated warnings), and proactive risk mitigation across populations. * **Call for Industry-Wide Implementation:** The full benefits of IDMP, including improved medication safety and public health outcomes, can only be realized through widespread and consistent implementation by pharmaceutical companies, regulators, and IT solution providers across the entire medicinal product life cycle.

An Industry Ontology for the Identification of Medicinal Products (IDMP)

Jul 18, 2022

This video introduces the Pistoia Alliance's IDMP Ontology project, which addresses the critical challenge of inconsistent interpretations of the ISO Identification of Medicinal Products (IDMP) standards within the pharmaceutical industry. Currently, IDMP standards are published as PDFs, leading to varied implementations across companies and regulatory agencies, hindering automated data processing, quality, and semantic interoperability. The project aims to augment these standards with a formal ontology, creating a semantically aligned and governed data model that acts as a "connecting bridge" for data interpretation across internal departments, suppliers, and regulators. The speaker emphasizes the importance of contextualizing complex concepts like "active moiety" to accommodate diverse scientific and regulatory perspectives, ensuring accurate representation while allowing for different expert views. The ontology is being developed collaboratively with major pharma companies and validated against real-world data from sources like FDA's GSRS, demonstrating its ability to answer specific competency questions and facilitate cross-organizational data integration for improved drug safety, innovation, and operational efficiency. Key Takeaways: * **Semantic Interoperability for Regulatory Compliance:** The IDMP Ontology directly tackles the lack of semantic alignment in pharmaceutical product data, a crucial step for achieving consistent regulatory compliance (FDA, EMA) and enabling automated data processing across the life sciences ecosystem. * **Ontologies as Foundational Data Bridges:** The project highlights the strategic value of ontologies in creating a unified "connecting bridge" for data interpretation, essential for harmonizing information flows within and between pharma companies, suppliers, and regulatory bodies. * **Contextualized Data Modeling for Complex Concepts:** The approach to modeling concepts like "active moiety" with contextual roles (e.g., regulatory, scientific, patent exclusivity) demonstrates a sophisticated method for managing inherent ambiguities and diverse expert perspectives in pharmaceutical data. This advanced data modeling is critical for developing robust custom software and AI solutions. * **Industry-Wide Collaborative Standard Setting:** The Pistoia Alliance's collaborative model, involving leading pharma companies (Bayer, Merck, GSK, Novartis, J&J) and regulatory agencies (FDA, EMA), underscores the industry's commitment to developing shared data standards that drive collective innovation, efficiency, and patient safety. * **Real-World Validation for Practical Application:** The project's emphasis on testing the ontology with actual data (e.g., FDA GSRS, pharma company data) and specific use cases ensures its practical applicability and demonstrates tangible value for solving real-world data integration and interpretation challenges, a key aspect of delivering effective consulting and software development.

Blockchain in Action: How IQVIA Built an App Streamlining Drug Labels

Jun 26, 2019

This video explores a real-world application of blockchain technology by IQVIA, a leading life sciences company, to streamline the complex and highly regulated process of managing prescription drug labels using Salesforce Blockchain. The speakers highlight how traditional methods for label changes are inefficient, involve numerous parties, and lack consistent version control, posing significant challenges for regulatory compliance and patient safety. Blockchain is presented as a transformative solution to these issues, offering an immutable ledger, distributed network, and consensus workflows to ensure the permanence, provenance, and real-time replication of critical label information across stakeholders, including pharmaceutical companies, regulatory bodies, and design teams. Key Takeaways: * **Blockchain for Regulated Content Management:** The video demonstrates a powerful application of blockchain in the pharmaceutical industry for managing highly sensitive and regulated content like drug labels, ensuring immutable evidence, auditability, and real-time consistency across a multi-party ecosystem. * **Addressing Operational Inefficiencies in Life Sciences:** Blockchain is positioned as a solution to overcome the inherent complexities and inefficiencies of traditional drug label management, which is characterized by disparate data sources, manual processes, and challenges in maintaining version control and audit trails. * **Architectural Paradigm Shift:** The speakers advocate for viewing blockchain as a new architectural layer for enterprise systems, specifically for recording immutable events and facilitating "collaborative coding" of smart contracts among different organizations, moving beyond its common association with supply chain or cryptocurrency. * **Enhanced Regulatory Compliance and Patient Safety:** By providing a trusted, shared record of all label changes and their history, the solution significantly enhances regulatory compliance (e.g., FDA, EMA, GxP) and enables rapid, secure updates to critical drug information, directly impacting patient safety. * **Salesforce's Role in Enterprise Blockchain:** The successful prototyping of this solution on Salesforce Blockchain underscores Salesforce's capability to provide a declarative, integrated platform for enterprise-grade blockchain applications, particularly within regulated industries. * **Data Provenance and Auditability:** The "blockchain Timeline view" feature, which tracks every change and its history, offers robust data provenance and audit trail capabilities, crucial for meeting stringent regulatory requirements.

Benefits of a Two Layer Regulatory Intelligence Platform

Mar 11, 2022

The speaker, Gion-Andri Büsser of IMTF, discusses the critical need for modern technology in compliance, driven by exploding costs of compliance and even higher costs of non-compliance. He introduces a "two-layer regulatory intelligence platform" concept, emphasizing an orchestration layer that centralizes the treatment of compliance alerts, automates processes, fosters collaboration, and provides a holistic view of data. The video highlights how advanced technologies, including machine learning and data science, can be leveraged within this architecture to significantly reduce manual work, improve efficiency, and enhance risk management. Key Takeaways: * **Ecosystem Approach to Compliance Technology:** The video advocates for viewing compliance technology as an integrated ecosystem rather than disparate, siloed software packages. This platform approach is crucial for comprehensive data utilization and decision-making. * **The Power of the Orchestration Layer (Layer 2):** A dedicated orchestration layer is presented as essential for consolidating and processing all compliance alerts (e.g., AML, fraud, sanctions), enabling flexible process automation, fostering collaboration across teams, and maintaining accurate, regulator-ready audit trails. * **AI/ML for Enhanced Efficiency and Risk Reduction:** The "magic" of the orchestration layer lies in its ability to leverage AI and machine learning for advanced functions such as intelligent auto-closure of routine alerts, pre-processing to highlight historical patterns, and more granular, accurate risk rating based on comprehensive customer history. * **Strategic IT and Change Management Benefits:** Implementing an orchestration layer provides significant IT flexibility, allowing organizations to introduce modern tools and interfaces without immediately replacing existing, potentially valuable, legacy detection systems (Layer 1). This enables a phased modernization approach, reducing disruption and risk. * **Continuous Adaptation to Evolving Threats:** The speaker underscores that financial crime and compliance challenges are an "ever-ending battle," with criminal behaviors constantly evolving (e.g., due to pandemics, crypto). This necessitates adaptive, forward-looking technology to anticipate and combat new threats.g., GxP, 21 CFR Part 11, FDA/EMA regulations).

🎓 Veeva Vault RIM Training | Regulatory Information Management Made Easy | Vistasparks Solutions

Jul 6, 2025

This video from Vistasparks Solutions provides an in-depth overview of their training program for Veeva Vault RIM (Regulatory Information Management), a critical cloud-based platform for the life sciences industry. The training aims to equip professionals with the knowledge and tools to optimize regulatory operations by managing global submissions, registrations, correspondence, and commitments within a unified system. It covers both functional and technical aspects of Veeva Vault RIM, from foundational concepts like document management and interface navigation to advanced topics such as system administration, lifecycle configuration, dynamic access control, and system integration. The program emphasizes real-world application through case studies, hands-on practice in sandbox environments, and preparation for industry-recognized Veeva Vault RIM certification, ultimately preparing individuals for roles in regulatory affairs, IT consulting, and compliance within the pharmaceutical and biotech sectors. Key Takeaways: * **Unified Regulatory Information Management:** Veeva Vault RIM centralizes and streamlines the management of all regulatory assets, including global submissions, registrations, health authority interactions, and commitments, providing a single source of truth throughout the entire product lifecycle. * **Enhanced Compliance and Efficiency:** The platform significantly reduces manual effort (up to 30%) by automating key processes like commitment and submission management, ensuring adherence to regional regulatory standards, and providing robust compliance reporting and audit trails. * **Comprehensive Skill Development:** The training caters to a wide audience, from regulatory affairs professionals to IT consultants and compliance teams, offering a structured learning path that covers Veeva Vault fundamentals, advanced system administration, configuration, and integration skills. * **Practical Application and Certification:** A strong emphasis is placed on practical application through real-world use cases, hands-on exercises in simulated environments, and dedicated preparation for the Veeva Vault RIM certification exam, which is highly valued in the life sciences industry. * **Global Regulatory Focus:** The curriculum directly addresses the complexities of global regulatory operations, including health authority response management, planning and executing submissions across US, European, and Asia-Pacific markets, and managing post-approval commitments. * **Integration with Enterprise Ecosystems:** The training highlights Veeva Vault RIM's integration capabilities with other Veeva Vault modules (e.g., Quality and Clinical) and other systems, underscoring its role within a broader regulated enterprise software landscape.

Veeva Vault RIM: Comprehensive Online Training learn from experts with proexcellency

This video provides a comprehensive overview of a training program for Veeva Vault RIM, detailing its extensive functionalities for Regulatory Information Management within the pharmaceutical and life sciences industries. It covers the platform's role in streamlining compliance processes, managing regulatory documents and submissions (including IND, NDA, MAA), and ensuring regulatory success. The training curriculum explores key areas such as system configuration, user access control, document versioning, workflow automation, health authority communication, regulatory reporting, global alignment, and robust data integrity and security measures essential for compliance with standards like GxP and 21 CFR Part 11. The content underscores the platform's ability to enhance efficiency, collaboration, and reduce compliance risks across various regulatory activities Key Takeaways: * **End-to-End Regulatory Lifecycle Management:** Veeva Vault RIM offers comprehensive capabilities for managing the entire regulatory information lifecycle, from initial document authoring and submission planning to dossier management, publishing, and long-term archiving, which is crucial for pharmaceutical and life sciences companies. * **Enhanced Collaboration and Data Integration:** Veeva Vault RIM facilitates cross-functional collaboration, enabling efficient information sharing and integration of regulatory data with other critical departments such as Quality Assurance and Clinical Operations, streamlining overall operational workflows. * **Strategic Reporting and Global Alignment:** The system provides powerful reporting and analytics tools for tracking submission status, compliance trends, and key performance indicators. It also supports global regulatory alignment, helping organizations manage submissions and adhere to diverse international regulatory standards. * **Risk Management and Continuous Improvement:** Veeva Vault RIM supports proactive regulatory risk management through impact analysis for changes and fosters continuous improvement by identifying and addressing process inefficiencies, contributing to sustained regulatory excellence.

RegTalks about Regulatory Information Management Systems (RIMS)

Nov 29, 2021

This RegTalks episode, featuring Lidia Canovas of Asphalion and Udo Griem of Körber Pharma Software, provides an in-depth discussion on Regulatory Information Management Systems (RIMS) within the pharmaceutical and biotech industries. The speakers emphasize the critical role of RIMS in managing medicinal product data, particularly in anticipation of the complex transition to ISO IDMP standards. Griem defines RIMS through three core pillars: a solid, data-oriented database serving as a single source of truth for product master data, a robust workflow engine to manage submissions and approval processes, and capabilities for structured data submissions to authorities. He advocates for a data-oriented approach over traditional document-driven methods to ensure data quality and consistency. Key drivers for RIMS implementation include the impending IDMP mandate, the industry's shift towards structured data, competitive pressures for faster time-to-market, and the need for organizational process optimization. RIMS are shown to be beneficial for companies of all sizes and product portfolios, fostering a culture of quality and improving cross-departmental collaboration. While regulatory affairs is the primary user, RIMS serve as a central hub, supporting cross-functional processes across clinical, ERP, safety/pharmacovigilance, MES, and label artwork management. A significant emerging trend highlighted is the connection of RIMS data to data lakes for future evaluation with artificial intelligence. The discussion also underscores the importance of experienced implementation partners who can bridge the gap between software solutions and organizational needs, ensuring successful deployment and continuous improvement. Körber's AI Manager RIMS aims to minimize compliance risks, enhance efficiency, enable teamwork, and reduce costs, with IDMP compliance being a high priority in its development roadmap. **Key Takeaways:** * **RIMS are Foundational for Regulatory Compliance and Efficiency:** RIMS are critical for managing complex regulatory data, streamlining submissions, and ensuring compliance with evolving standards like IDMP, which is rapidly approaching and will significantly increase data complexity. * **Data-Oriented Approach is Paramount for RIMS:** A consistent, data-oriented design with a well-organized database is considered superior to document-driven approaches, ensuring high data quality, consistency, and adaptability for future regulatory requirements. * **RIMS Drive Cross-Functional Integration and Quality Culture:** Beyond regulatory affairs, RIMS act as a central hub, connecting and supporting various departments (e.g., clinical, ERP, safety, MES, QA) to improve collaboration, reduce error rates, and shorten response times across the pharmaceutical value chain. * **AI Integration is an Emerging Trend for RIMS Data:** There is a growing focus on connecting RIMS data to data lakes, specifically for evaluation with artificial intelligence, indicating a future direction for leveraging regulatory information for advanced insights and automation. * **Implementation Partners are Crucial for Successful RIMS Adoption:** Experienced partners with deep regulatory and product knowledge are vital for guiding companies through organizational and process changes, customizing solutions, and ensuring successful integration and continuous improvement. * **RIMS Benefits Extend to All Company Sizes and Diverse Portfolios:** While historically adopted by large multinationals, RIMS are now essential for small and mid-tier firms, including startups, to effectively build and scale regulatory organizations and manage diverse product portfolios beyond human medicine.

2022 RDCA-DAP Workshop: Case Study 3, Duchenne Regulatory Science Consortia (D-RSC)

Oct 5, 2022

This video presents a case study from the Duchenne Regulatory Science Consortia (D-RSC) by the Critical Path Institute, focusing on efforts to accelerate therapeutic development for Duchenne Muscular Dystrophy (DMD). Speaker Terina Martinez highlights the significant challenges in DMD drug development, including high clinical trial failure rates, disease complexity, and difficulties in patient selection and endpoint measurement. To address these issues, D-RSC has developed a Clinical Trial Simulation (CTS) tool. This tool leverages a rich, integrated database of patient-level data from numerous clinical trials and natural history studies to train and validate quantitative disease progression models. The goal is to enable in silico evaluation and refinement of clinical trial designs, optimizing parameters like sample size and duration, and simulating drug effects. The tool is undergoing regulatory qualification with both the EMA and FDA, emphasizing its rigor and potential to improve trial efficiency, reduce participant burden, and stimulate further data sharing within the rare disease community. Key Takeaways: * **Data-Driven Clinical Trial Optimization:** The D-RSC's Clinical Trial Simulation (CTS) tool exemplifies how aggregating and analyzing extensive patient-level data from clinical trials and natural history studies can be leveraged to create quantitative disease progression models. This enables in silico evaluation and optimization of trial designs for rare diseases like DMDai. * **Regulatory Qualification of Novel Methodologies:** The active pursuit of regulatory qualification for the CTS tool through both EMA's Qualification of Novel Methodologies and FDA's Fit for Purpose Initiative highlights the growing importance of formally validating advanced computational tools for use in drug development and decision-making. This directly * **Impact on Trial Efficiency and Data Sharing:** Such simulation tools are crucial for improving clinical trial efficiency by optimizing sample size, trial duration, and patient selection, thereby reducing the burden on rare disease patient populations. Regulatory approval also acts as a strong catalyst for increased data sharing among stakeholders, underscoring the value of robust data integration and management. * **Addressing Rare Disease Challenges with Technology:** The initiative directly tackles the unique complexities of rare disease drug development, including high failure rates, heterogeneity in disease progression, and the need for better clinical endpoints, by providing a data-driven approach to de-risk and accelerate therapeutic advancement.

NNIT Webinar: IDMP enforcement in Europe in 2021

Jan 25, 2021

This video provides a critical update on the European Medicines Agency's (EMA) Identification of Medicinal Products (IDMP) initiative, focusing on its enforcement timelines and the latest developments in the implementation guide. The speakers, regulatory affairs experts from NNIT, detail the expected publication of IDMP Implementation Guide Version 2 on February 22, 2021, which sets the mandatory go-live date for PMS (Product Management System) Iteration 1 fields for the industry by February 22, 2023. The discussion highlights the significant impact on regulatory affairs, the need for comprehensive data management and quality, and the ongoing evolution of EMA's approach to IDMP, including an agile documentation strategy and updates on substance data management. Key Takeaways: * **Imminent IDMP Enforcement:** The EMA has set a concrete timeline for IDMP enforcement, with PMS Iteration 1 becoming mandatory for industry by February 22, 2023, following the publication of Implementation Guide Version 2. This signals a definitive move towards compliance after years of delays. * **"One Side IDMP, Always IDMP" Mandate:** An unofficially confirmed but critical rule states that once a company submits IDMP information for one product, all other products in its portfolio must subsequently follow suit. This eliminates the possibility of small-scale pilots and necessitates a comprehensive, portfolio-wide IDMP strategy from the outset. * **Holistic Data & Process Transformation:** IDMP compliance extends beyond IT systems, requiring significant organizational effort in locating and ensuring the quality of required data, as well as fundamental changes to business processes across regulatory, commercial, and potentially clinical operations. * **Evolving Substance Data Management:** The EMA is actively cleansing and synchronizing substance data through its EU SRS and SMS projects, with a focus on aligning with the FDA's GSRS. This indicates a push towards greater international harmonization in substance identification and management. * **Limitations of Standard RIM Systems:** While many Regulatory Information Management (RIM) system providers are incorporating IDMP roadmaps, their solutions primarily address data model expansion and basic functionality. They often do not cover critical aspects like comprehensive data quality monitoring, integration with other enterprise systems, or the necessary adjustments to overall submission processes, highlighting the need for broader data engineering and process re-design efforts. * **Strategic Industry Preparation is Crucial:** Companies must proactively prepare by staying updated on regulatory changes, mapping substances and referentials, and raising internal awareness. It's essential to plan for all product types (centralized, mutual recognition, decentralized, and national procedures) from the beginning, rather than focusing solely on centralized products.

Is this Stock Better Than Salesforces Inc? | Veeva Systems Inc (NYSE:VEEV)

Aug 11, 2022

This video provides an investment analysis of Veeva Systems Inc., detailing its origins, core offerings, market dominance, and growth trajectory within the life sciences industry. The speaker explains how Veeva was founded to address the specific cloud-based CRM needs of life sciences companies, which were not adequately met by general platforms like Salesforce. The discussion highlights Veeva's two main ecosystems: the Commercial Cloud, providing CRM and analytical services, and Veeva Vault, a suite of applications for managing clinical trials, industrial regulations, and other critical data points. The video underscores Veeva's position as the de facto cloud service provider for the global life sciences sector, enabling drug companies to develop products, enhance sales and marketing, and ensure regulatory compliance. It also covers Veeva's impressive customer growth, high revenue retention rates, and future revenue projections, attributing its success to a first-mover advantage and the continuous demand for specialized solutions in a highly competitive market. Key Takeaways: * **Specialized Industry Focus:** Veeva Systems' success stems from its targeted approach to the life sciences industry, demonstrating the critical need for specialized cloud-based CRM and data management solutions beyond generic enterprise platforms. * **Comprehensive Platform for Life Sciences:** Veeva offers two key ecosystems: the Commercial Cloud for CRM and analytics, and Veeva Vault for managing clinical trials, regulatory compliance, and other crucial data, covering a broad spectrum of pharmaceutical operations. * **Market Dominance and Entrenchment:** Veeva is identified as the "de facto cloud service provider" for the global life sciences industry, indicating a strong first-mover advantage and significant market share in a highly regulated and specialized sector. * **Addressing Core Industry Needs:** Veeva's solutions directly support drug companies in three vital areas: effective product development and market entry, efficient marketing and sales to healthcare professionals, and maintaining strict compliance with industry and government regulations. * **High Customer Retention and Growth Drivers:** The company's impressive customer growth (over 1,000 customers including major pharma giants) and high revenue retention rates (around 120%) reflect the ongoing demand for its services, driven by intense competition and regulatory requirements within life sciences.

The Good, the Bad, and the Ugliness of Regulation [No. 86 LECTURE]

Feb 23, 2023

This video, "The Good, the Bad, and the Ugliness of Regulation," features Professor Susan Dudley discussing the origins, functions, and impact of administrative agencies and regulations in the U.S. It delves into the historical context of administrative law, tracing the evolution from early economic regulations to the modern prevalence of social regulations concerning environment, health, and safety. Professor Dudley explains the constitutional debates surrounding agency powers, the significance of the Administrative Procedure Act, and various methods for measuring the vast scope and economic impact of regulations. She highlights that while regulations are often perceived as burdensome, they are fundamentally justified by market failures such as externalities and asymmetric information, which are particularly relevant in complex industries like pharmaceuticals and life sciences. Key Takeaways: * **Foundational Role of Agencies:** Administrative agencies emerged to address the increasing complexity of society, operating under legislative delegation (e.g., Administrative Procedure Act of 1946) to create detailed regulations that Congress lacks the expertise or capacity to write. * **Shift to Social Regulation:** While early regulation focused on economic aspects, there has been a dramatic and continuing increase in "social regulation" since the 1970s, covering areas like environment, health, safety, and workplace conditions. This category directly encompasses the regulations critical to the pharmaceutical and life sciences industries. * **Market Failures as Justification:** The primary rationale for regulation stems from market failures, including externalities (costs borne by third parties, like pollution) and asymmetric information (where one party lacks crucial information, such as product safety or efficacy). * **Vast and Growing Regulatory Landscape:** There are at least 100 federal agencies issuing thousands of regulations annually, with 50-100 "economically significant" regulations (>$100 million impact) each year.ai helps its clients manage through AI and consulting services. * **Challenges in Measuring Regulatory Impact:** Unlike fiscal budgets, there's no single, comprehensive measure for the total impact of regulations, making it difficult for businesses to fully grasp and comply with the "stock" of existing rules (Code of Federal Regulations) and the "flow" of new ones (Federal Register). This complexity highlights the value of specialized consulting and AI solutions for compliance tracking.

RIM Implementation in times of IDMP - Asphalion Webinar

Jul 26, 2022

This video explores the critical intersection of Regulatory Information Management (RIM) system implementation and the ongoing transition to ISO Identification of Medicinal Products (IDMP) standards. The speaker details the current uncertainties surrounding IDMP, the phased rollout of EMA's SPOR project (including PMS and the DADI web form), and the profound impact these changes have on the pharmaceutical industry. A central theme is how RIM systems serve as essential tools to navigate IDMP compliance, emphasizing the need for digitalization, robust data governance, and strategic data migration during implementation. Key Takeaways: * **IDMP as a Digitalization Catalyst:** ISO IDMP is presented not merely as a regulatory requirement but as a significant driver for comprehensive digitalization and the establishment of strong data governance frameworks within pharmaceutical companies, necessitating standardized and interoperable data. * **RIM Systems are Core for IDMP Compliance:** Regulatory Information Management (RIM) systems are highlighted as indispensable for IDMP compliance, facilitating efficient data collection, organization, and communication. Future RIM systems are expected to directly support data submission to EMA's PMS via fire messages, evolving beyond current xEVMPD processes. * **Data Quality and Governance are Foundational:** Successful IDMP compliance and RIM implementation are contingent upon high-quality, harmonized data. Companies must prioritize data cleaning, enrichment, and mapping, integrating IDMP requirements from the initial planning stages of any RIM project. * **Navigating Phased IDMP Rollout Complexity:** The EMA's phased implementation of IDMP through the DADI web form (starting with Centrally Authorized Products (CAPs), then Nationally Authorized Products (NAPs)) introduces a complex transitional period. Organizations must plan to manage the coexistence of legacy and new systems and processes effectively. * **Strategic Implementation is Crucial:** Regardless of company size or portfolio, a well-defined strategy for IDMP compliance and RIM implementation is vital. This involves a thorough assessment of existing data structures, internal processes, technological capabilities, and future expectations to select the most compatible RIM system and implementation approach.

Mastering Change Management Veeva RIM Implementation Case Study

Nov 26, 2024

This video explores the critical role of Organizational Change Management (OCM) in ensuring successful technology implementations, particularly within the life sciences industry. The speaker details OCM's core principles—communication, training, stakeholder engagement, and continuous improvement—and explains why it is essential for enhancing adaptability, reducing resistance, boosting productivity, mitigating risks, and aligning with strategic goals. The presentation culminates in a case study of a global Veeva Regulatory Information Management (RIM) module implementation, demonstrating how a structured OCM framework can lead to successful adoption, improved regulatory processes, enhanced compliance, and streamlined documentation across diverse stakeholder groups. Key Takeaways: * The video provides a detailed overview of Organizational Change Management (OCM) principles, emphasizing its critical role in successful technology adoption within the life sciences sector. * It highlights OCM's importance in enhancing adaptability, reducing resistance, boosting productivity, mitigating risks, and ensuring strategic alignment for complex implementations. * A key focus is on a real-world case study involving the global implementation of Veeva Regulatory Information Management (RIM) modules * The case study demonstrates how tailored strategies, comprehensive communication plans, stakeholder engagement, and continuous improvement are essential for achieving regulatory process enhancement, improved compliance, and streamlined documentation. * Common resistance points (e.g., fear of the unknown, loss of control, increased workload) are addressed with practical strategies, offering valuable insights for managing the "people side of change" during software rollouts. * Success measurement in OCM is detailed through metrics like team engagement, communication effectiveness, training completion, adoption rates, and performance outcomes, providing a framework for evaluating implementation success.

Season 1 Episode 5: Turning Content into Memorable Customer Experiences

Jun 6, 2025

This video, featuring marketing leaders from Genentech and hosted by Veeva, explores the critical transformation from content creation to delivering memorable customer experiences within the life sciences industry. The discussion highlights the strategic shift required for pharmaceutical companies to move beyond product-centric marketing to a more holistic, personalized, and data-driven approach. Key themes include the necessity of organizational change, the pivotal role of real-time data in shaping and optimizing customer interactions, and the imperative to foster a culture of continuous experimentation and rapid content iteration to meet evolving customer demands and competitive pressures. Key Takeaways: * **Evolution of Pharma Marketing:** The industry is moving from a product-first, brand-oriented approach to a holistic, experience-driven marketing discipline that unifies content and customer experience, driven by increasing competition and customer demands for better healthcare experiences. * **Content vs. Experience:** Content is necessary but not sufficient; true customer experience is built on deep customer understanding and personalization, akin to transforming a "house" (content) into a "home" (experience). This requires breaking down silos between content creation, experience delivery, and measurement. * **Organizational Transformation Drivers:** Successful change requires full senior leadership commitment, a clear vision, addressing discomfort with the status quo, and crucially, aligning incentive structures to support new ways of working and moving away from outdated processes. Leaders must be prepared to "blow up the old bridge" to fully embrace new methodologies. * **Data as the Core Enabler:** Real-time data from every customer engagement (or lack thereof) is fundamental for crafting effective messages, optimizing content, and informing strategic adjustments. This necessitates integrated MarTech platforms and a robust content supply chain to provide a holistic view of performance. * **Embrace Experimentation and Speed:** The industry must stop "planning to perfection" and instead embrace continuous experimentation, rapid iteration, and a willingness to put out "90% right" content, measuring and optimizing constantly to adapt to fast-changing technology and consumer behavior. * **Redefining Customer Engagement:** The traditional view of the sales representative as the sole "quarterback" of the customer relationship is evolving. A multi-channel approach is needed, recognizing a diverse web of decision-makers (including patients and caregivers) beyond just the prescriber. * **Future of Content:** The goal is to create significantly more engaging, personalized content (e.g., "20x the content") at scale, faster, and more affordably, with integrated, real-time measurement feeding back into content generation.

RegTalks about Regulatory Information Management Systems (RIMS)

Nov 5, 2021

This video explores the critical role of Regulatory Information Management Systems (RIMS) within the pharmaceutical industry, particularly in light of the upcoming transition from XEVMPD to the more complex ISO IDMP standard. Featuring insights from Veeva's Director of Strategy for Vault RIM, Katrin Spaepen, the discussion highlights the drivers for RIMS adoption, essential capabilities of future systems, and the multi-departmental nature of their use. The speakers emphasize that RIMS are key to managing vast amounts of regulatory data, ensuring compliance, and optimizing operations for medicinal products. Key Takeaways: * **Strategic Importance of RIMS:** RIMS are fundamental for data management, operational efficiency, and maintaining regulatory compliance in the pharmaceutical industry, especially with the impending, more complex ISO IDMP standard. * **Drivers for RIMS Adoption:** Companies adopt RIMS for three primary reasons: driving enterprise-wide digital transformation, achieving process efficiencies and cost optimizations in regulatory domains, or ensuring compliance (often driven by mandates like IDMP). These drivers influence the scope and approach to implementation. * **Core Capabilities of Future RIMS:** Effective RIMS must offer native support for both data and documents, ensure synchronization between them, feature an open architecture for data exchange with non-RIM systems, provide a complete view of license data across the enterprise, and embed real-time reporting and business intelligence dashboards. * **Multi-Departmental Utility:** RIMS are not solely for regulatory affairs; they serve as an enterprise-wide solution involving various departments such as regulatory operations, CMC writers, medical writers, manufacturing, quality control, and safety, particularly in processes like post-approval variation management. * **Crucial Role of Implementation Partners:** Successful RIMS implementation necessitates strong partnerships for process re-engineering, organizational impact assessment, change management, gap analysis, and defining key performance indicators (KPIs) and user requirements (URS). * **Veeva's Market Presence:** Veeva's Vault RIM suite (encompassing submissions, archive, publishing, and registration) is positioned as a leading end-to-end solution supporting the full regulatory process, indicating its significance in the industry.

2019 Veeva R&D Summit Keynote: Veeva Vision

Sep 12, 2019

This.ai offers specialized consulting. The discussion of clinical data management, regulatory compliance (e.g. This video explores Veeva's vision for an integrated "Development Cloud" for the life sciences R&D sector, delivered through a keynote address at their 2019 R&D Summit. The speaker outlines Veeva's core vision to build an industry-specific cloud for life sciences, encompassing applications, data, professional services, and an ecosystem of partners, all aimed at improving and extending human life. Key themes include Veeva's foundational values ("do the right thing," customer success, employee success, speed) and significant product innovations across various R&D domains. The presentation details advancements in clinical data management (e.g., agile study design, autosave), the introduction of Vault Safety for pharmacovigilance, and the development of "Safety AI" to automate the processing of unstructured safety content. Other innovations include continuous publishing for regulatory submissions, enhanced collaborative authoring capabilities through Microsoft Word integration, and a complete quality suite (Quality Docs, QMS, Training). The speaker emphasizes the importance of integration via "Spark" technology to connect various Vaults and external systems, and the necessity for customers to embrace business process changes alongside new technology adoption. Key Takeaways: * **Integrated Development Cloud Strategy:** Veeva is pursuing a comprehensive "Development Cloud" strategy, aiming to provide an integrated suite of modular applications that serve as the "operating system for drug development," covering clinical, safety, regulatory, and quality functions to break down silos. * **Strategic AI Investment in Pharmacovigilance:** Veeva is making a significant move into AI with "Safety AI," a specialized product designed to process unstructured content (PDFs, emails, text) using an AI engine to generate review-ready safety cases, addressing a complex and error-prone area in pharmacovigilance. * **Focus on Continuous and Incremental Innovation:** The company emphasizes "reimagining" existing processes and delivering incremental improvements (e.g., agile study design, quick view, autosave in clinical data management, continuous publishing) to enhance efficiency, user experience, and adaptability to evolving industry needs like frequent protocol amendments. * **Modernizing Regulatory and Content Management:** Innovations like "Vault Publishing" with continuous publishing capabilities for eCTD formats and tight integration with Microsoft Word for collaborative authoring demonstrate a strong commitment to streamlining regulatory submission processes and improving content management within a compliant framework. * **Importance of Integration and Ecosystem:** Veeva's "Spark" integration technology is critical for connecting various Vault applications and external systems, facilitating seamless data flow and business processes across the entire R&D lifecycle, and enabling a more unified operational environment. * **Business Process Transformation is Key:** The speaker explicitly highlights that adopting new technologies, particularly transformative ones like continuous publishing, necessitates significant changes in business processes and roles, underscoring that technology implementation is not merely a tool adoption but a fundamental shift in operations.

SCRS Talks: Connecting Patients, Sites, and Sponsors to Improve Clinical Trials

Jul 23, 2020

This. ai provides. This video explores the pressing challenges faced by patients, research sites, and sponsors in clinical trials, particularly exacerbated by the COVID-19 pandemic. Bree Burks from Veeva Systems highlights the industry's struggle with disparate systems and processes that limit data sharing and collaboration, leading to increased patient burden, financial instability for sites, and inefficiencies in drug development for sponsors. The discussion emphasizes the critical need for a more connected and patient-centric approach, advocating for technology that empowers rather than replaces research sites. Veeva's strategy to build a unified platform for the entire clinical trial ecosystem, including dedicated solutions for sites and patients, is presented as a key opportunity for improvement. Key Takeaways: * **Fragmented Clinical Trial Ecosystem:** The industry suffers from a lack of technological connectivity and data sharing between patients, research sites, and sponsors, leading to significant operational inefficiencies and increased burden across all stakeholders. * **Shift to Patient-Centricity and Site Empowerment:** There's an urgent need to design clinical trials with patient experience in mind and to empower research sites with integrated technology solutions, moving away from the concept of "site-less trials" towards "technology-empowered sites." * **Platform Approach to Technology:** Research sites should strategically evaluate technology partners that offer a unified, integrated platform rather than managing numerous disparate point solutions, which often leads to costly and complex integration challenges. * **Veeva's Expanding Clinical Trial Ecosystem:** Veeva is actively expanding its offerings beyond sponsors and CROs to include purpose-built, seamlessly integrated technology for research sites and patients, aiming to create a comprehensive, connected platform for the entire clinical trial lifecycle. * **Regulatory Compliance as a Core Feature:** Technology solutions for clinical trials must inherently address stringent regulatory requirements, with providers like Veeva explicitly offering 21 CFR Part 11 compliant tools to streamline operations while ensuring adherence. * **Strategic Technology Partnership for Sites:** Sites are advised to seek long-term technology partners that understand their complex needs, align with their vision, and can provide evolving, integrated solutions, rather than focusing solely on current features.