Boston | September 3-4, 2025
Powerful Community, Fresh Ideas
Agenda
More sessions and speakers will be announced soon.
Tuesday, September 2
Wednesday, September 3
Quality in biopharma is constantly evolving, driven by digitalization, artificial intelligence, and increasing regulatory and patient demands. Discover how a leading biopharma innovator is accelerating change by aligning leadership, enabling data-driven agility, and breaking silos to transform its Quality function.
Merck shares how it simplified pharmacovigilance operations and improved efficiency within safety and across functions. Hear how it eliminated 10 technology applications and is standardizing data cross-functionally with a connected safety platform.
Sr. Director, Business System Management & Innovation
Vice President, Veeva Safety
Attend this fireside chat for a regulatory leader’s real-world insights and practical strategies to modernize legacy publishing processes, navigate multi health authority platforms, and rethink the RIM implementation model. Discover how the right internal conversations are foundational to driving meaningful change.
Vice President, Regulatory
Executive Director, Global Regulatory Operations Strategy & Innovation
Senior Director, Veeva RIM Strategy
Global biopharma shares strategies for accelerating clinical trials and product launches with Development and Quality Clouds, AI, and Operational and Process Excellence.
Learn how Merck simplified clinical operations and data management with the Veeva Clinical Platform. Hear about the value realized and best practices for successful adoption – and how these learnings apply to organizations of all sizes.
Senior Vice President, Head of Global Clinical Trial Operations
Learn how the Document Control Homepage provides a centralized hub to track and manage key document control processes and aids in ensuring processes are completed in a timely manner.
Collaborate with CROs in real-time and get data oversight and greater control over safety outputs. Easily identify bottlenecks and track case quality and average handling times to improve operational efficiency.
Solution Engineer
Learn about recent updates designed to streamline and enhance change management processes. Discover how the Quality-RIM Connection improves efficiency and facilitates data sharing between Veeva Quality and Veeva RIM.
Senior Product Manager, RIM Connections
Team Manager, Veeva RIM Services
Discover strategies for optimizing cross-functional workflows in life sciences, and how the Veeva Industry Cloud supports end-to-end processes across multiple applications.
See how the Safety-EDC connection automates the transfer of serious adverse event (SAE) data, removing data managers’ reconciliation effort. Discover the newest release in 25R2 that adds a closed loop process, so Veeva EDC is aware of Safety decisions.
Explore the benefits of accelerating deviation data sharing across the CDMO-sponsor interface, highlighting how real-time collaboration can enhance product quality, expedite batch release, and strengthen compliance readiness.
Senior Director, Veeva QMS Product Strategy
Hear how a connected safety platform seamlessly automates adverse event (AE) intake from medical information, product quality complaints (PQCs), and clinical subject reportable events. Learn how connections with Veeva EDC, QMS, and MedInquiry streamline case intake, reduce reconciliation, and improve efficiency.
See how Vault action layouts simplify the user experience by providing the right information at the right time for the right role and context.
Principal Product Expert, Vault Platform
Explore how Process Monitor helps identify bottlenecks, understand cycle times, and visualize KPIs to optimize business processes.
Discover the automated data transfer between Clinical Operations and EDC that reduces transcription effort and risk. Learn how to automate the creation of protocol deviations and payments. The newest release (25R2) also enables the automatic transfer of Closeout PDFs to Veeva eTMF.
Hear the roadmap and vision of Veeva 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, Veeva Training
General Manager Veeva LearnGxP
Hear Veeva’s vision and roadmap to modernize and accelerate validation management processes. See demos of the latest features in Veeva Validation Management and get your questions answered.
Senior Product Manager, Validation Management
Hear the roadmap and vision of Veeva LIMS. See demos of the latest innovations and get your questions answered.
Director, Product Management
See upcoming AI capabilities for unstructured intake and narratives, and get a preview of how expanding the unified safety solution with Veeva Safety Workbench and Veeva Safety Signal will provide a reliable safety data foundation for faster and more accurate insights.
Vice President, Product Management, Veeva Safety
Discover key features delivered over the past year for Veeva Registrations, Submissions, Submissions Publishing, and Submissions Archive, and insights into this year’s roadmap highlights. We’ll also provide updates on eCTD 4.0, Active Dossier, our Global Content Plan connection, and other features designed to reduce data management efforts, helping biopharmas achieve end-to-end process efficiency.
Vice President, Product Management, Regulatory
Explore Vault Platform advancements to simplify implementation, customization, and ongoing management. See ways to leverage process monitor, Word-formatted outputs, and action triggers, and get a preview of upcoming AI capabilities and security, reporting, and Direct Data API enhancements.
Vice President of Product Management, Vault Platform
Discover the latest enhancements and upcoming features for Veeva eTMF and Veeva Study Startup, designed to accelerate and improve end-to-end trial management. We’ll highlight how electronic CDA and a stronger Veeva RIM to Veeva Clinical Operations connection improve feasibility and study activation. Plus, learn about features like risk-based QC, full study audit trail exports, and a new multilingual TMF Bot model that supports inspection readiness and TMF efficiency.
Discover the latest enhancements and upcoming features for Veeva Study Training that reduce overtraining and create visibility into training performance. This includes enhancements to automatically file training logs in Veeva eTMF and enable site learners to transfer GCP credits between sponsors. Plus, see planned enhancements, such as the ability to send the training matrix for internal reviews before publishing.
Learn what’s next for Veeva EDC, Veeva CDB, and Veeva eCOA. Hear recent highlights and upcoming innovations as we deliver for patients, sites, and sponsors. Join the interactive Q&A following the presentation.
Senior Vice President of Product, Clinical Data
SVP Product Management, Sites and Patients
Join our Veeva Safety product team for live roadmap Q&A.
Vice President, Product Management, Veeva Safety
Vice President Product Architect, Veeva Safety
Principal Product Manager, Veeva AI (Safety)
Sr. Director, Product Management, Veeva SafetyDocs
Director Product Management, Veeva Safety Signal & Workbench
See the latest capabilities and enhancements in Veeva Connections. Discover how to streamline cross-functional business processes, improve data quality, and automate workflows.
Senior Director, Development Cloud Strategy
Discover the latest enhancements and upcoming features for Veeva Site Connect that support sponsor-site collaboration from start-up to closeout. This includes improvements to share unblinded content and enhance automatic document exchange. Plus, see planned enhancements to capture site staff’s roles and responsibilities through Veeva Site Connect and increase automation in safety distribution.
Discover the latest enhancements and upcoming features for Veeva CTMS and Veeva Payments that streamline trial execution and site payments. This includes improvements to support complex trials, CTMS Transfer, the Clinical Operations-EDC Connection, and fee schedule management. We’ll also highlight future innovation around study management, site monitoring, site contracting, and invoicing in Veeva Site Connect.
Senior Product Manager
Discover the latest enhancements and upcoming features for Veeva Site Connect that support sponsor-site collaboration from start-up to closeout. This includes improvements to share unblinded content and enhance automatic document exchange. Plus, see planned enhancements to capture site staff’s roles and responsibilities through Veeva Site Connect and increase automation in safety distribution.
See how regulatory teams use Global Content Plans to reduce cycle times for submission activities. Learn to optimize dispatch processes and update cycles from core packages to local submissions.
Generate documents from Vault data with the new Microsoft Word formatted outputs. See how to configure, test, and easily use it to display data in specific formats.
Principal Product Expert, Vault Platform
Hear the roadmap and vision for Veeva QualityDocs and Veeva Station Manager, see demos of the latest innovations, and get your questions answered.
Director of Product Management, QualityDocs, Station Manager, and Training
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.
Senior Director of Product Management, Veeva Batch Release
Discover ways CRO and biopharma use a shared PV solution to collaborate and improve safety outcomes. Discussing best practices for business alignment, gain insights on maintaining oversight, increasing efficiency, and key operational reports and metrics.
Explore Veeva’s government strategy to speed submissions through multi-health authority collaboration platforms. Two biopharmas will share insights on two different submission platforms that support real-world pilots and future opportunities in health authority interactions.
Explore the Veeva RIM implementation journeys of Aimmune, a Nestlé Company, and BridgeBio: discover how a change champion fosters collaboration and user adoption, and learn about an innovative Veeva RIM configuration for granular expense tracking and improved financial forecasting.
Senior Director, Regulatory Operations and Information Systems
Sr Director, Global Regulatory Operations
Regulatory Operations Specialist
Get a preview of Veeva AI Agent use cases in Development Cloud and Quality Cloud applications. Understand how Veeva AI in the Vault Platform and embedded into Vault applications will enable broad adoption to help users analyze data, draft documents, and extract information out of unstructured content.
SVP, Veeva AI Solutions
An emerging biopharma shares its journey to achieve effective study oversight in outsourced trials with Veeva CTMS. Learn strategies for gaining stakeholder buy-in and driving effective change management. You’ll also hear how CTMS Transfer provides real-time access to data from CROs to save time and prevent errors.
Vice President, Clinical Operations
A leading cancer center shares a site’s perspective on pain points in clinical trials, as well as insights into quick-win programs that sponsors and CROs can implement to address them. The team will also outline how biopharmas can pick technology solutions that improve site success.
Two top biopharmas share how to unify systems and processes and increase data access with Veeva Clinical Operations. Discover how they execute new operating and governance models and plan to use study-level data across their portfolios to prepare for inspections, review study progress, and improve trial execution.
We’re entering a new era of clinical data management. Veeva Clinical Data’s CTO, Drew Garty, will share our vision for advancing this shift and our innovation strategy to enable it. Learn how Amgen is preparing to simplify and standardize operations to scale transformative change.
AVP Clinical Systems and Analytical Reporting & Data Management
Chief Technology Officer, Clinical Data
See how Veeva CTMS provides real-time visibility and oversight, reducing compliance risk and improving quality. Discover how CTMS Transfer simplifies and standardizes CTMS data between sponsors and CROs to increase efficiency.
Solution Consultant, Clinical Operations
Hear from a panel of leaders on their investments in AI within quality management. Learn how AI has transformed their quality processes, the business case for these investments, and the tangible value realized within Veeva Quality Cloud.
Explore Fujifilm Biotechnologies’ journey from a site-based quality approach to a unified, global quality management system—beginning with document management. Hear how the transformation began with Veeva QualityDocs and how the partnership with Veeva will drive consistency across all quality applications.
Vice President Global Quality Systems
Director, Global Quality Systems
Hear how Validation Management helped C4 Therapeutics transition from a hybrid paper-based process, using QualityDocs and a PDF e-signature solution, to a fully digital validation approach. Discover how this shift enabled them to increase their workload capacity and ensure compliance through digital transformation.
Manager, GxP Systems
Vice President, Quality
Discover Alvotech’s journey with Veeva LIMS, from selection to real-world results. Learn about implementation best practices, key improvements made, and the resulting impact on QC operations.
QC Operation Senior Specialist
AbbVie, Cognizant, and Veeva partnered to drive safety innovation and optimize operations. Using shared, data-driven goals with metrics for quality, compliance, and efficiency, the teams collaborated to challenge traditional ways of working and deliver measurable improvements.
Director, Office of Safety Operations – PV Systems
Project Delivery Leader
Senior Director, Veeva Safety Strategy
Gain insights from a Roche’s end-to-end RIM implementation journey. Hear what worked, what didn’t, and the practical strategies that drove success – along with insights on long-term user adoption and workforce enablement.
Regulatory Data and Content Leader
Hear two distinct perspectives from Lexicon Pharmaceuticals and Daiichi Sankyo about how they are leveraging Veeva Submissions Publishing. Explore the unique strategies and benefits that each organization used to maximize value to streamline their regulatory processes.
Executive Director, Global Head of Regulatory Operations
Hear how a top biopharma is gaining value by streamlining cross-functional processes and improving efficiencies across Safety, Clinical, Regulatory, and Quality with Veeva Connections.
Discover how to use Veeva process monitor to analyze and optimize processes, and leverage Vault reporting and dashboards to create and track business KPIs for greater insights. Get an overview of recent and upcoming enhancements and ways to maximize data value.
Senior Director or Product, Vault Platform
A top biopharma shares its vision to enhance research site collaboration with Veeva Site Connect. Learn how to streamline safety letter distribution, automate document exchange, and improve site-facing processes for studies across a portfolio.
A top biopharma shares its approach to improving feasibility and accelerating site activation with Veeva Study Startup. Hear how standard feasibility questions and reusable responses save time and reduce site burden. You’ll also learn how to leverage data and key metrics to speed study start-up for priority trials.
Emerging biopharmas and CROs will showcase how Veeva EDC streamlines trial execution through submission. Discover real-world productivety gains from eliminating redundant activities. Learn how these companies are expanding adoption for improved site experience and efficiency.
Learn how Novo Nordisk navigated change over time. Discover tips for adopting change, moving beyond implementation, and maximizing long-term value. Explore methods to improve data flow across systems and proactive action across R&D teams.
Vice President
Thursday, September 4
Explore how this leading biopharma manages quality processes for combination products. Discover best practices for incorporating MedTech requirements while scaling technology systems.
Learn how a biopharma company is transforming its release decision-making with Veeva Batch Release. From solution selection to go-live, discover lessons learned and the real-world outcomes.
Learn how a CDMO and Sponsor use digital infrastructure to enhance customer experience, from technology transfer through to lifecycle management. Discover how a strategic relationship built on innovation and transparency generates mutual value.
Merck and UCB are streamlining end-to-end safety processes with a unified solution from intake through case processing, reporting, and analysis. Hear how they are driving efficiencies and improving signal detection while maintaining compliance.
Sr. Director, Business Processes and Systems
Benefit Risk Excellence Lead
Hear from a panel of biopharma leaders from Sanofi and Eli Lilly who have implemented regulatory GenAI solutions. Discover their best practices for measuring value, building end-user trust, and driving scalable adoption.
Global Head Medical Writing and Document Management
IT Senior Director – Global Regulatory Affairs
Executive Director, Veeva RIM Strategy
VP, Regulatory Operations
Discover Vault Platform tools for managing configurations, best practices, and methodologies for complex changes using software development lifecycle concepts such as config-as-code.
Director of Product Management, Vault Platform
Sanofi shares its approach to streamlining study training by implementing Veeva Study Training as a single, inspection-ready solution. Learn how to eliminate the need for multiple disconnected systems across study teams and site staff.
Clinical Learning and Development Head
Apellis and University of Pennsylvania share how TMF groups can help transform sponsor-site relationships from transactional exchanges to collaborative partnerships. Learn how emerging biopharmas use Veeva eTMF to improve TMF completeness and quality and mitigate risk for site documents.
Director, Clinical Documentation & TMF
Director, Regulatory Affairs
Director, Clinical Strategy
Astellas details how it will ensure accurate site and investigator data with Veeva OpenData Clinical. Hear how access to a global data directory unified with Veeva Clinical Operations ensures reliable information, simplifies processes, and accelerates trial execution.
Chapter Lead – Veeva Clinical & Safety, R&Dx, DigitalX
Learn how clinical data leaders maximize value from the Clinical Data Platform. You’ll hear best practices from enterprise to emerging biopharma companies and diverse adoption approaches, both highly structured and agile. Delve into features and process changes that delivered efficiency gains like saving two days per data manager, per week, on data review.
Explore how the Document Readiness panel allows users to see the status of asynchronous document content processes, helping to resolve rendering issues.
Director of Product
Learn how Veeva Validation Management improves the efficiency and traceability of equipment qualification activities.
Senior Solution Consultant
Learn how to access extracted text from your uploaded Vault documents. Without exporting Vault source files, the unformatted text can be sent to and leveraged by LLMs and Gen AI services.
Learn how Veeva RIM publishes a U.S. eCTD 4.0 submission using Veeva Submissions Publishing and preview U.S. eCTD 4.0 forward compatibility – all within the same processes used today, without any add-ons.
See how the Safety-EDC connection automates the transfer of serious adverse event (SAE) data, removing data managers’ reconciliation effort. Discover the newest release in 25R2 that adds a closed loop process, so Veeva EDC is aware of Safety decisions.
Learn from industry leaders in this panel discussion on balancing training compliance with consumer learning behaviors. Discover how they are evolving their strategies to stay current.
Discover how an effective cloud technology strategy drives inorganic growth. You’ll learn best practices for migration, accelerated onboarding, and managing through change.
Director, Documentation, ITQA & Training
See how Avidity Biosciences uses Veeva LIMS to enhance partner oversight, ensure compliance, and scale operations. Explore its selection process and its organizational impact.
Director, IT
Safety leaders discuss how they are efficiently managing pharmacovigilance agreements (PVAs), pharmacovigilance system master files (PSMFs), and other safety-related content, while improving compliance and inspection readiness.
Hear from a panel of leaders from Sanofi, Amgen, and AstraZeneca about the evolution of their regulatory organizations and the key drivers behind that change: Veeva RIM process unification, data quality demands across R&D, and evolving regulations.
Head, Global Submission Management and Data Operations
AVP, Global Regulatory Affairs
Senior Director, Regulatory Systems
Executive Director, Veeva RIM Strategy
Discover how a leading biopharma unlocked the power of the Veeva Platform for RIM Planning by engaging with Veeva’s Technical Services team to build a custom Submission Planning feature, based on data from their Veeva Clinical & Safety applications.
Explore Pfizer’s journey establishing a Veeva Center of Excellence, including key considerations for defining structure, scope, and responsibilities to maximize operational value and drive innovation.
Dive into powerful Vault Platform enhancements that streamline and automate critical business processes, customize user experiences, and measure processes with actionable insights. Hear how these new capabilities enable more robust and efficient Vault solutions.
Principal Product Expert, Vault Platform
Director of Product Management, Vault Platform
Bayer shares its plans to accelerate registry submissions with Veeva Disclosures. Learn how centralizing disclosures on a unified platform with Veeva eTMF and Veeva CTMS enables automation, simplifies processes, and ensures compliant submissions.
Head of Clinical Trial Management Services and Solutions
Senior Director Disclosures Strategy
A top biopharma will share how it moved feasibility into Veeva Study Startup, replacing manual tools with standardized, technology-enabled processes. Learn how early engagement, data reuse, and process improvements are helping reduce site burden, improve data quality, and build stronger site relationships.
See how effective collaboration between an emerging biopharma and CRO resulted in end-to-end study benefits. Gain practical examples of how to align people, process, and technology to support sponsor oversight (ICH E6 R3).
Alcon and panel share their vision for a new approach to eCOA delivery. This session highlights practical strategies to build faster, simplify processes, and accelerate timelines across organizations.
Sr. Director, Clinical Data Management & Medical Intelligence • Global Biometrics
Explore Veeva’s upcoming product approach to helping organizations master the complexities of jurisdictional control with Veeva Batch Release.
Director of Batch Release Strategy
Explore how to automate global post-market case processing. Simplify intake of unstructured data, improve data quality with embedded configurable QC workflows, and use rule-based narrative generation.
Vice President Product Architect, Veeva Safety
See how Quick Queries creates significant time savings for sites and CRAs in EDC, and for data managers in CDB. Discover how this feature enables users to create and respond to queries in just a few clicks, eliminating hours of manual effort.
Learn how to facilitate accurate batch release and product lifecycle management with Active Dossier by maintaining a list of current documents for a given product in multiple markets.
SMB Services Lead, Veeva RIM
Senior Product Manager & Team Lead, Veeva RIM
Discover open-source tools that increase administrator and developer productivity. Built with Vault API and an intuitive user interface, easily modify configurations, execute queries, clean up sandboxes, and more.
Learn how three new CDB features make data managers more effective. See how new visualization tools in the Query Metrics Dashboard and Clean Patient Tracker enable risk-based approaches, and how assignable Observations let data managers collectively evaluate data points before creating queries.
Learn how to create efficiency and accelerate cycle times with a seamless end-to-end QC workflow, including embedded test execution, embedded control charts, and review by exception.
Senior Director, Veeva LIMS Strategy
Director, Product Management
See how a unified safety solution accelerates data flow for earlier signal detection and aggregate reporting, links signals back to source case data, supports more detailed analysis, and streamlines RMPs and aRMMS based on signal outcomes.
Sr. Director, Product Management, Veeva SafetyDocs
Explore how real-time data sharing and automated workflows between Clinical Operations and Vault CRM can strengthen site relationships and speed clinical trial execution.
Learn how Veeva eCOA simplifies the management and completion of clinical outcome assessments for sponsors, sites, and patients.
Hear how a biopharma company is optimizing their Quality Cloud with a plan for continuous investments in innovation. Learn how to prioritize and synthesize internal requests, new features, and ongoing improvements into an actionable plan that drives long-term value and efficiency.
Learn how a biopharma successfully evaluated and implemented Veeva Training for its GxP-first needs. It’ll share their approach to maintaining standard configuration while optimizing business processes.
Hear how a biopharma optimized validation processes, enhanced user experience, and increased efficiency by transitioning from a paperless solution to one unified with the quality ecosystem. Discover key lessons learned, best practices, and the business impact achieved.
Discover how a biopharma accelerated time-to-market and optimized its quality framework with Veeva LIMS. Learn about its digital-first strategy and the measurable results it delivered.
Discover how a top biopharma’s change management strategy will position them for rapid implementation, strong user adoption, and lasting success.
Explore the implementation strategies and process transformations undertaken by two global companies as they share key insights and approaches that led to operational improvements and streamlined work on a global scale.
AstraZeneca streamlines regulatory and clinical processes end-to-end with the RIM-Clinical Operations Connection. Discover key strategies and realized efficiencies, including how a connected approach accelerates submissions and enhances global trial execution.
Senior Director, Regulatory Systems
Discover how Vault Platform extracts large datasets at high-speed, and how to leverage Direct Data API and open-source accelerators to move away from traditional API extraction methods.
See how the Quality-Safety Connection automates intake by sharing product quality complaint and adverse event (AEs) data between Veeva QMS and Veeva Safety.
In this expert session, gain a deeper understanding of monitoring events in Veeva CTMS. We’ll explore new functionality, like how to seed relevant issues into monitoring event records and manage monitoring events across multiple sites using schedules. We’ll also review tips for managing Word Formatted Output trip report templates for greater flexibility and usability.
Senior Product Manager
Hear real-world examples of automating clinical data collection from sites and downstream data flow. Learn initial lessons from Lilly’s recent EHR-EDC integration, while MSK will offer insights on approaching interoperability.
Sr. Director, eSource Capabilities
Sr. Director Clinical Research Informatics
Learn how data managers can focus on the data that truly matters. We’ll explore risk-based data management and tangible steps towards achieving it. A top biopharma will showcase their strategies for collaborative data review, automation and AI, and shaping the future of clinical data management.
Connect with Veeva product managers and peers for an in-depth discussion on Veeva Submissions Publishing, provide feedback on our roadmap, and exchange best practices to optimize your use.
Senior Product Manager
Connect with Veeva product managers and peers for an in-depth discussion on Veeva Registrations, provide feedback on our roadmap, and exchange best practices to optimize your use.
Connect with Veeva product managers and peers for an in-depth discussion on Active Dossier, Global Content Plans, and Submissions Content Plans, exchange feedback on our roadmap, and exchange best practices to optimize your use.
Senior Product Manager & Team Lead, Veeva RIM
Product Manager
Get the latest updates on Station Manager with a live demo of real manufacturing use cases. Learn how it drives productivity and enhances compliance on the shop floor.
Solution Consultant
Sr. Director, QualityDocs Strategy
Learn how to leverage Direct Data API and Veeva’s open-source accelerators to build integrations that can extract all Vault data at high speed.
Director of Product Management, Developer Experience
Discover how recent enhancements to the Quality-RIM Connection improves efficiency in the change control process and data sharing between Veeva Quality and Veeva RIM.
Senior Product Manager, RIM Connections
Discover how to make your refresher training more effective, efficient, and engaging. Learn best practices for managing refresher content and assignments, and get a preview of upcoming features designed to enhance the refresher training experience.
VP, Training Strategy
Solution Consultant, Quality
Explore how an emerging biotech can maximize investment and accelerate innovation with Development and Quality Clouds. Dive into real-world examples to break down silos, streamline processes, enhance data flow, and provide a single source of truth from clinical trials to manufacturing.
Get a preview of Veeva AI Agent use cases in Development Cloud and Quality Cloud applications. Understand how Veeva AI in the Vault Platform and embedded into Vault applications will enable broad adoption to help users analyze data, draft documents, and extract information out of unstructured content.
SVP, Veeva AI Solutions
Learn best practices to simplify clinical processes, including monitoring and protocol deviations, directly from Clinical Operations and Data Manager experts. Explore the current Clinical Operations-EDC connection and the future state with expanded products and use cases. Plus, discuss standardizing data flows for eSource and non-EDC sources across study phases.