Powerful Community, Fresh Ideas
Clinical Data Agenda
Sunday, Sept. 8
Monday, Sept. 9
Hear Moderna’s remarkable journey from a small scale biotech clinical manufacturer to a global commercial player during the Covid 19 pandemic and beyond. Jennifer White, Senior Vice President of Global Quality at Moderna will share how Moderna’s mission to create and deliver transformative medicines for patients was enabled through its innovation, technology, and quality culture.
Senior Vice President, Global Quality
Vice President, Vault Quality & Manufacturing
Join the fireside chat exploring Vault RIM implementation challenges, insights for success, and organizational impact. Discover Roche’s journey to achieve global visibility and collaboration with a single, unified regulatory platform.
Global Head, Regulatory Operations and Business Excellence
Vice President, Vault RIM
Hear Veeva’s vision for clinical data and new innovations in patient capture. Learn how AbbVie and UCB are leading change and seeing the results of transformation in their organizations.
Head of IT Digital Clinical Operations
Director, Clinical Data Management
Director, EDC/IRT Data Systems
VP, Strategy, Clinical Data
AbbVie and Merck discuss transformation of pharmacovigilance operations. Hear how they are empowering teams, improving end-to-end processes within safety and across functional areas, and leveraging automation.
AVP, PV Operations and Global Process Enablement
Director, Veeva Community of Practice
Vice President, Vault Safety
Senior Director, Strategy – Vault Safety
Hear from an emerging and top biopharma on strategies to reduce cost, accelerate processes from clinical trials to product launch, and establish a foundation for growth using Veeva Development Cloud.
Astellas shares its holistic approach to improving end-to-end processes and the journey to building a unified clinical operations platform.
Business Strategy Lead, Clinical Operational Excellence
Lead, Enterprise Platform Veeva, Clinical Trial Operations Technology
Vice President, Development Cloud Strategy
An expert panel shares how transitioning from legacy systems to a unified training solution enhanced compliance and qualification processes. Discover the tangible benefits of a unified approach, from streamlined quality management to improved data accuracy, and enhanced collaboration.
Senior Quality Manager
Vice President, Information Technology
Associate Director, Training and Document Management
Director, Documentation, ITQA and Training
Senior Manager, Training Strategy
Discover how Takeda enhanced productivity and user access by consolidating and transforming the document management system after a major acquisition. Learn about their strategies to simplify access for casual users, including the implementation of Station Manager and Process Navigator.
Head of QMS
Join experts from Amgen for an in-depth discussion on their adoption of a risk-based validation process to enhance risk management and data integrity governance. Discover their comprehensive strategy that places validation at the core of operational and data integrity programs. Gain valuable insights into how technology, processes, and people are integrated to support their Risk-Based Validation program.
Director, Quality Systems
Associate Director
Sr. Manager, DTI Global Quality
Senior Specialist Quality
Director, Vault Validation Management
Hear how Neurogene and Verve Therapeutics have modernized QC operations by adopting a cloud-based LIMS. Learn about the catalysts for change, what is critical when evaluating a solution, the ease and speed of implementation, what they have achieved so far, and where they are going next with Vault LIMS.
QC Analyst IV
Quality Control, Associate Director
Editorial Director
Roche, AstraZeneca, and Vir Bio share insights on their migration to Vault Submissions Publishing, evolving the publisher role and submissions process, and transforming their end-to-end publishing operations to reduce submission timelines.
Manager, Regulatory Operations
Associate Director, Regulatory Publishing
Senior Regulatory Submission Manager
Hear from Mersana, Ocugen, and MacroGenics on optimizing regulatory operations through leveraging the right tools, choosing the right operating model – outsourcing or insourcing, streamlining processes, and better managing change. By understanding and defining success, organizations can better utilize resources to improve regulatory operations.
Senior Director, Regulatory, Quality, and Clinical Solutions (RQCS)
Director, Regulatory Operations
Associate Director, Regulatory Operations
Learn from an expert panel of sponsors and sites on ways that data management can improve the site experience. Hear how current efforts are being received in the site community — what is working, and what isn’t useful? Leave with recommendations to empower sites and gain flexibility in development workflows.
Vice President, Global Clinical Trial Operations – Sites, Data, Quality
Director, CSSE Process Excellence and Delivery
Senior Director, Clinical Research Administration
Chief Executive Officer
Director, Vault CDMS Strategy
Hear the UCB journey from study-by-study to enterprise eCOA adoption. Explore how they accelerated delivery while standardizing patient data capture and management across their organization. Hear best practices from their experience including implementation, validation, library development, and end-user engagement.
Head of IT Digital Clinical Operations
Vice President, Strategy, MyVeeva for Patients
Join a panel of experts as they discuss the pivotal role of services in Randomization and Trial Supply Management (RTSM) development. Explore how early prediction of unknowns, building for flexibility, and streamlined mid-study amendments can impact your trials. Gain valuable insights into creating an adaptable and resilient partnership when working with Veeva RTSM.
Associate Director, Clinical Systems
Vice President, Clinical Business Operations
Group Head, Systems and Standards
Hear how Haleon successfully established its global safety foundation and outsourcing strategy after separating from GSK. They’ll dive into their approach, lessons learned, as well as share the impact and value of establishing a new foundation for all safety case processing worldwide.
Head of Safety Tech
Operations and Support Director, Clinical & Safety
Global Director of Case Processing
Learn about AbbVie and Bayer’s site engagement initiatives and how Veeva Site Connect enhancements will further improve efficiency and site choice.
Head of Global Business Operations
Head of Clinical Trial Management Services and Solutions
Vice President of Strategy, Site Connect
Hear how Cerevel automates study training with a purpose-built solution. They will share best practices for leveraging Vault Study Training, as well as tips to improve training effectiveness.
Manager, Quality Operations
Abbvie shares how R&D IT leaders built initial business case for a Veeva Center of Excellence (CoE) and explain how it will transform operations, management, and business processes across Vaults. Astellas discusses the maturing and evolution of their CoE after initial setup, and how they optimize functions and roles as the organization matured.
Lead, Enterprise Platform Veeva, Clinical Trial Operations Technology
Director, Veeva Community of Practice
Senior Director of Strategy, Development Cloud
Recommended approaches and lessons learned when leveraging Vault APIs, including Direct Data API, to export data for data warehouse, data lake, and AI use cases.
Director, Product Management, Vault API & SDK
Veeva and PwC will share insights on the practical application of AI and advanced technology in Quality Management Systems (QMS). Learn specific use cases and see how PwC and Veeva work together to help organizations turn AI ambitions into actionable strategies that enhance quality management.
Partner, Global Quality Lead
Sr. Director, Strategy – Vault QMS
Resilience, Agios, and ImmunityBio share their journeys of transitioning from paper and siloed legacy systems to Vault Validation Management. Discover the diverse drivers behind their decisions and explore the benefits, including enhanced efficiency, real-time data access, and lowered validation management costs.
Director, Quality Applications
Director, Digital Quality and Data Integrity
Associate Director, Validation
Senior Manager, Vault Validation Management
Moderna shares how it’s embraced technology and quality culture to effectively manage rapid growth. Discover how, with a digital approach, the quality organization drives operational excellence and innovates in achieving safety, trust, and delivery of mRNA medicine to patients worldwide. By adopting industry best practice processes, Moderna quickly matured its quality systems and processes to ensure the timely delivery of transformative medicines.
Executive Director, Digital Quality
Learn about a new approach to optimizing QC and increasing right first time. While legacy LIMS solutions have grown stagnant, see how Veeva is redefining LIMS and transforming QC operations with a unified solution.
Senior Director, Vault LIMS
Learn how Apellis and Arcus leveraged a new data-centric approach to improve document management and regulatory processes.
Head of Regulatory Information Management
Senior Manager, Global Regulatory Operations
Senior Director, Regulatory Information and Systems
To achieve sustainable, long-term integration of end-to-end RIM, organizations must embrace a new perspective. Join Roche as they explore challenges and ways to address change management, global system adoption, and data quality.
Informatics Product Manager
Innovation and Sustainment Leader
Explore how to overcome the top 5 barriers that constrain trial execution. Hear practical advice from Data Management leaders at Takeda, Alcon, GSK, and Syneos Health that have led change, achieved success, and continue to drive efficiency from build to submission.
Head of Clinical Data Engineering
Head of CDO
Director, Clinical Data Management
VP, Strategy, Clinical Data
SVP, Head Customer Success, FSP360
Examine lessons learned after implementing decentralized clinical trials. Leave with practical solutions to move past the challenges of DCT, and uncover a new chapter of patient-centric trials.
Head, Global Data Management
Chief Strategy Officer
Senior Vice President, Clinical Research
Sr. Director CDMS Strategy
Allucent illustrates the drug supply complexities involved with cell and gene therapy studies and how they relate to Randomization and Trial Supply Management (RTSM) systems. Explore the distinctive aspects of RTSM within this innovative field, emphasizing patient-centric approaches, intricate supply chain logistics, and regulatory considerations. Discover a custom solution built by Veeva RTSM that addresses the drug supply challenges of cell and gene study design.
Vice President, Head of Global Operations, Cell and Gene Therapy
Gain insights on how CRISPR achieved operational efficiencies and leveraged real-time data visibility for oversight and better decision-making. They’ll present best practices for managing in-house pharmacovigilance activities and resources with lean teams.
Executive Director, Head of Global Pharmacovigilance and Risk Management
Senior Medical Director, Global Safety and Risk Management
Senior Manager
Moderna explores the benefits of TMF data standardization to support increased operational efficiency and improved collaboration with study partners.
Director, Clinical Trial Systems and Operations
Regeneron discusses how Vault reports and dashboards improve visibility into operational processes, application usage, and KPIs. See recent enhancements as well as get a first look at the roadmap and key upcoming capabilities.
Senior Manager, Global Development Quality Technology & Compliance
Director, Product Management, Vault Platform
Biopharmas explore best practices for ongoing release management. Learn how their teams optimize the release processes and accelerate delivery of new business capabilities across multiple Vaults.
Hear Lilly’s journey to automate end-to-end start-up in one system, including implementation pain points and successes, cycle time improvements, and lessons learned.
Associate Director
Director, Trial Capabilities
Discover CSL’s vision and journey towards enterprise learning management evolution, focusing on advancing people and technology and integrating Vault Training as part of their quality ecosystem. Learn about their governance model, GxP and non-GxP training management, and organizational changes for training success.
Head, Enterprise Quality Training and Documentation
Senior Director, Information Technology
Forge facilitates efficient external collaboration within a controlled environment, enhancing client access to data and documents. Discover how this transparency empowers them to manage quality events with compliance, modernize quality processes, and connect QA and QC teams to effectively meet customer needs.
Director, Quality Management
Bristol Myers Squibb shares its quality adoption journey and showcases the tangible benefits of recent supplier quality management (SQM), content management, and metrics reporting initiatives. Learn about their approach to integrating value metrics into their processes, demonstrating how quality systems can generate significant business value.
Senior Director, Digital Strategy and Governance, GQ
Hear how Alvotech pivoted from continuing to invest in its existing LIMS and processes to a better way of managing QC. They will share how they identified the right time to stop investing in a legacy LIMS and how Vault LIMS will modernize their QC operations with simplified processes.
Director, Vault Platform
Senior Director, Vault LIMS
Human-driven translation rework delays submissions, increases risk of non-compliance in local labels, and impacts patient safety. Discover how Sanofi cut translation times by an average of 75% using AI-powered automated translations with Vault RIM as context.
Head, Global Submissions Management
Senior Product Manager
Director, AI Consulting and Implementation
Discover how Biocryst streamlined complex report development with Vault RIM for high quality reports as well as best practices for report level content planning for clinical study reports, development safety update reports, and risk management plans.
Associate Director, Global Regulatory Operations
See Veeva’s realized vision for connected clinical data through an end-to-end demo spanning patients, sites, and sponsors/CROs. This updated demo showcases enhanced eCOA patient interactions and the new Safety-EDC Connection. Experience the power of connection using Veeva’s EDC, CDB, RTSM, eCOA, CTMS, and Safety systems.
Chief Technology Officer, Clinical Data
Solution Consultant, Clinical Data
Solution Consultant, Clinical Data
Solution Consultant, Clinical Data
Leaders at Praxis Precision Medicines and Karuna Therapeutics, a BMS company, describe their journey to bring eTMF in-house, including creating effective system processes. They’ll also share tips for driving efficiencies with sponsor-owned Vault eTMF.
Associate Director, Clinical Study Business Operations
Sr. Manager Clinical Documentation
Director, Clinical Strategy
Join AbbVie and Sarepta for a panel discussion on how they improved management of pharmacovigilance system master files (PSMFs), pharmacovigilance agreements (PVAs), and additional risk minimization measures (aRMMs).
Executive Director, Global Pharmacovigilance Operations and Quality Management
Associate Director, Innovation & Technology
Senior Director, Vault Safety Strategy
Bayer describes how they replaced manual processes with Vault Study Training. They will share best practices to streamline and centralize training for research sites and internal study teams and drive inspection readiness.
Clinical Capability Strategy Lead
Gilead accelerated end-to-end change control and increased visibility across quality and regulatory teams with Quality-RIM connection. Learn implementation best practices and lessons learned as well as how the team decreased cycle times.
Sr. Director IT
Senior Director of Strategy, Development Cloud
Accelerate business processes and improve user experience with the latest capabilities including action layouts, advanced start workflow, notification categories and preferences, search synonyms and collections, and Vault Mobile.
Senior Product Expert, Vault Platform
Inhibrx, CG Oncology, and Biocryst will share their operating models and how Vault CTMS enables better study oversight and scalability.
Manager, Clinical Trials Systems and Processes (Contract)
Vice President Operations
Vice President, Clinical Operations
Director, Vault Clinical Strategy
Tuesday, Sept. 10
Hear the roadmap and vision of Vault QMS. See demos of the latest innovations and get your questions answered.
Senior Director, Vault Product Management, QMS
Learn about Veeva’s GxP training vision and roadmap, see demos of the latest innovations, and get your questions answered.
Senior Product Manager
General Manager, LearnGxP
Hear Veeva’s vision and roadmap to modernize and accelerate validation management processes. See demos of the latest features in Vault Validation Management and get your questions answered.
Director, Product Management, Vault Validation Management
Hear the roadmap and vision of Vault LIMS. See demos of the latest innovations and get your questions answered.
Director, Product Management
Senior Director, Vault LIMS
Hear key Vault Registrations, Submissions, Submissions Publishing, and Submissions Archive capabilities delivered over the past year and roadmap highlights. See how Vault RIM is further optimizing end-to-end processes and get an update on health authority question extraction and Active Dossier progress.
VP, Product Management, Vault RIM
Learn what’s next for Vault EDC and Veeva CDB, including recent innovations and upcoming enhancements for this year. Plus, ask the Veeva team questions during an interactive Q&A.
Senior Vice President, Products, Vault CDMS
See how the milestone workspace simplifies EDL and milestone management in Vault eTMF and our plans to help you conduct periodic, risk-based QC. Learn how we’ve streamlined feasibility surveys in Vault Study Startup and how standard questions will enable you to provide default answers for sites.
Site Connect has changed to make it easier than ever to exchange documents and study information with sites! See how you can exchange documents with any site directly in Vault Clinical Operations, regardless of what eISF the site uses.
Learn about the innovations and enhancements coming to Veeva RTSM, and ask the Veeva team questions during an interactive Q&A.
See enhancements for global case processing, reducing case handling time, and new operational metrics. Get a sneak peek of Vault Safety Workbench, Vault Safety Signal, more Vault SafetyDocs use cases, and the next phase of safety automation.
Vice President, Product Management, Vault Safety
Explore recently released capabilities, including action layouts, and discuss upcoming platform plans focused on enabling new applications, making implementations easier, and ensuring scalability and availability.
SVP Product Management, Vault Platform & Technology
Hear the roadmap and vision for Vault QualityDocs and Vault Station Manager, see demos of the latest innovations, and get your questions answered.
Director, Product Management
Hear Veeva’s vision and roadmap to enable faster, more confident GMP release and market-ship decisions with Batch Release. See demos of the latest innovations, and get your questions answered.
Director of Batch Release Strategy
Sr. Director, Product Management
Join the Vault RIM product team to discuss key features from the past year, the latest in regulatory guidelines and developments, and the future roadmap for Vault RIM.
VP, Product Management, Vault RIM
Learn how we’ve made monitoring more flexible and enhanced support for outsourced trials with oversight issue tracking and streamlined data transfers between sponsors and CROs in Vault CTMS. See how we’ve improved site fee management and our plans to support master protocols and complex trials across arms and cohorts in Vault Payments.
Streamlining processes through automation is key in Vault Study Training – from released features such as automated user creation and training assignments to planned enhancements such as training completion monitoring and delegated responsibility training. Join this roadmap session to hear about all of the exciting new things coming to Vault Study Training!
Explore the functionalities of Veeva RTSM’s Enterprise Hub for cross-study reporting and analytics, focusing on both standard and ad-hoc reporting. With an initial focus on supply optimization, join us to see how this new tool can improve supply chain management and participate in an open discussion with other clinical supply experts.
Ask questions live with the Vault Safety product team.
Vice President, Product Management, Vault Safety
Principal Product Architect, Vault Safety
Direction Product Management
Senior Product Manager, SafetyDocs
Build real-time submissions and eliminate content duplication through automated document transfer from Vault Quality, Vault Clinical, and Vaults PromoMats to Vault RIM.
Senior Solutions Consultant, Vault RIM
Discuss Veeva’s automation and AI strategy including Veeva’s plan to help customers leverage new technologies with the AI Partner Program.
Senior Director of Strategy, Development Cloud
General Manager, Vault
SVP Product Management, Vault Platform & Technology
PPD and ImmunityBio share insights on strategic approaches for continuous innovation in quality. Learn how proactive roadmap planning supports evolving business and system needs through optimization and innovation, and discover tips for maintaining operational excellence on your continuous innovation journey.
Vice President, Quality Risk Management, Quality Enterprise Learning & EHS
Sr. Director, Quality Systems & Compliance
Sr. Director Quality Strategy
Practice Manager, Enterprise Quality
Practice Director, R&D Managed Services
Merck shares the advancements in it’s quality complaints management, showcasing streamlined operations through an interconnected system. Discover how this enhancement improves workflow efficiency and streamlines issue resolution.
Product Line Lead and Executive Director, DMMD Quality Operations
Associate Director, Digital MMD, Quality & Lab Value Team
Sr. Director Technical Product Management
Discover how using a modern cloud-based LIMS with a cloud-based integration platform can automate data workflows and stream high quality, contextualized QC lab data to increase productivity and data value with measurable ROI. Learn how integrating these data repositories with other enterprise data can enhance insights through AI.
Vice President, Strategy
Senior Director, Vault LIMS
See how Eli Lilly and BeiGene set up a successful data quality program. Build a robust foundation for reliable and efficient regulatory processes by using a systematic approach to ensure high data quality and understanding the strategic importance of data stewardship and governance.
Senior Director, Global Regulatory Affairs
Director, RIM, Global Regulatory Operations
Staying current with Vault RIM to deliver better outcomes among evolving regulations, operating models, and organizational demands is not easy. Get practical guidance from Sanofi and Sarepta on agile release management, Center of Excellence models, and risk-assessment based validation of Vault RIM innovation.
Digital GRA Service Line Manager
Senior Director, Regulatory Operations, RIMS/DMS Lead
Learn about the innovations and enhancements coming to Veeva eCOA, and ask the Veeva team questions during an interactive Q&A.
SVP Product Management, Sites and Patients
Hear how Acelyrin and Atorus successfully navigate trial complexity and diverse data sources to increase efficiency. Learn tips to eliminate redundant data collection, respond faster to protocol deviations, and achieve higher-quality data integration with upstream partners and downstream analytics.
Vice President, Global Clinical Data Management
Team Lead, CDB Strategy
Associate Director, eClinical Programming and Solutions
Discover how Inhibrx is automating data flow between safety, clinical, and regulatory to reduce manual overhead, risk, and reconciliation as well as improve data quality. Gain best practices on connecting processes across business functions, safety outsourcing, and establishing a single trusted source of pharmacovigilance information internally and with partners.
Vice President Operations
Successful clinical trials depend on strong relationships between CROs, sponsors and other partners. This session will explore how strengthening these collaborations can help optimize clinical supply management and overall study design.
Executive Director, Biometrics Technical Services
Discover the latest Vault Connections and enhancements and see how they are transforming biopharma processes, improving data quality, and simplifying compliance.
Senior Director of Strategy, Development Cloud
Merck shares their journey establishing a framework for realizing value from Vault Platform and Veeva Development Cloud. They‘ll discuss key metrics and framework to monitor, track, and communicate Vault Platform benefits delivered to the organization.
Senior Director, Clinical Operations (ID/Vaccines)
Clinical Practice Manager, NA R&D BC
Parexel shares how the study-locking capability in Vault CTMS enabled data migration without any downtime.
Senior Director, Solution Enablement
Vice President, Data and Technology
The global clinical research workforce is facing a critical shortage. To ensure the future of drug development, we must invest in workforce development, support site-based professionals, and foster collaboration across the industry. Join this interactive session with ACRP leaders to discuss ways to create a more robust, diverse, and sustainable research ecosystem.
Executive Director
Kura Oncology shares best practices for enabling CRO success in a sponsor-owned eTMF including developing effective oversight metrics, business processes, and governance.
Director, Clinical Systems/Document Management
Senior Director, Operational Excellence
Director, Clinical Strategy
Steve Gens explains what constitutes a high-performing regulatory organization based on a decade of research on world-class RIM operations. Three biopharmas – GSK, Cerevel, and Sarepta – identified in the Gens & Associates benchmark will outline ways to achieve and sustain high regulatory performance.
Managing Partner
Vice President, Global Regulatory Operations
Senior Director, Global Regulatory Operations
Senior Director, Regulatory Operations, RIMS/DMS Lead
Learn how the adoption of intelligent technologies like Generative AI are evolving clinical data management. Discover how Veeva Vault integrates with AI to remove efficiency barriers, and see innovative use cases for the Veeva Clinical Platform.
Senior Manager
Discover how Veeva RTSM revolutionizes Randomization and Trial Supply Management (RTSM) with its single-tenant approach and tear-off model. This presentation will show how our unique methodologies streamline RTSM product development, ensuring that your next study is always on the latest version of our core platform. Learn about our coordinated and precise validation approach, which ensures seamless and reliable operations, ultimately driving superior outcomes for our customers without the need for additional validation of the Veeva RTSM platform at any time.
See Vault Clinical Operations in action and the value of a unified platform in this live demo.
Join Vault Safety customers to share best practices, hear from product experts, and discuss latest and upcoming capabilities.
Senior Director, Vault Safety Strategy
Principal Product Architect, Vault Safety
Learn about powerful open-source tools to view/edit configuration, execute VQL queries and export results, and easily summarize and delete Sandbox test data.
Developer Support Engineer
Director, Product Management, Vault API & SDK
Learn how union reports can help visualize and analyze complex data models and improve existing reports.
Director, Product Management, Vault Platform
Discuss how different organizations approach managing users, both at a domain/cross-Vault level as well as Vault-specific level.
Senior Product Expert, Vault Platform