Powerful Community, Fresh Ideas
Agenda
Sunday, Sept. 8
Monday, Sept. 9
Hear a biopharma’s remarkable journey from a small-scale biotech clinical manufacturer to a global commercial player during the COVID-19 pandemic and beyond. Learn how their mission to create and deliver transformative medicines for patients was enabled through their innovation, technology, and quality culture.
Join the fireside chat exploring Vault RIM implementation challenges, insights for success, and organizational impact. Discover a top biopharma’s journey to achieve global visibility and collaboration with a single, unified regulatory platform.
Hear Veeva’s vision for clinical data and new innovations in patient capture. Learn how two top biopharmas are leading change and seeing the results of transformation in their organizations.
Top 10 biopharmas 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 for greater efficiency.
Hear from an emerging and top biopharma on Development Cloud strategies to reduce cost, accelerate processes from clinical trials to product launch, and establish a foundation for growth.
This top biopharma shares its holistic approach to improving end-to-end processes and the journey to building a unified clinical operations platform.
Join a global pharma as they discuss how Veeva’s collaboration with partners facilitates the integration of AI into transformative Quality Management System (QMS) programs. Discover their journey of pursuing AI and advanced technologies within a major QMS implementation, leveraging embedded use cases and third-party AI tools to improve decision-making and efficiency.
A biopharma 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, enhanced collaboration, and substantial cost savings.
Explore how a top biopharma enhances productivity and user accessibility through Process Navigator in QualityDocs, facilitating efficient access to critical procedures and documentation for casual users.
Hear from three biopharma companies that 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.
Three biopharmas 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.
Hear from two biopharmas 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.
Learn from an expert panel of sponsors and sites on ways 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.
A biopharma leader shares the 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.
Hear how a top consumer health company successfully established its global safety foundation and outsourcing strategy. They’ll dive into their approach, lessons learned, as well as share the impact and value of one safety solution for all domestic case processing worldwide.
Learn how recent enhancements to Veeva Site Connect are helping further improve efficiency and site choice.
Hear how one biopharma 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.
Top biopharmas share how they are developing Veeva centers of excellence and maximizing Development Cloud value. Learn how their teams help drive cross-Vault alignment for data governance, release and change management, and processes that span multiple functional areas.
Top 20 biopharma dives into recommended approaches and pitfalls to avoid when leveraging Vault APIs, including Direct Data API, to integrate external applications and tools with Vault Platform.
Discover a global biotech’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.
A panel of industry experts share their journeys of transitioning from siloed and 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.
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.
A top pharma 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.
Learn how two emerging biopharmas leveraged a new data-centric approach to improve document management and regulatory processes.
To achieve sustainable, long-term integration of end-to-end RIM, organizations must embrace a new perspective. Join a top biopharma as they explore challenges and ways to address change management, global system adoption, and data quality.
Explore how to overcome the top 5 barriers that constrain trial execution. Hear practical advice from Data Management leaders that have led change, achieved success, and continue to drive efficiency from build to submission.
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.
Understand the unique 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.
Gain insights on how an emerging biopharma 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.
A biopharma explores the benefits of TMF data standardization to support increased operational efficiency and improved collaboration with study partners.
Top biopharma 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.
Hear this top biopharma’s journey to automate end-to-end start-up in one system, including implementation pain points and successes, cycle time improvements, and lessons learned.
Join a top pharma 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.
Gain insights from a customer panel 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.
A CDMO enables efficient external collaboration in a controlled environment, providing better access to data and documents. Learn how this transparency allows them to manage quality events quickly and accurately, modernize quality processes, and connect QA and QC teams to effectively meet customer needs.
Hear how a pharmaceutical company 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.
Human-driven translation rework delays submissions, increases risk of non-compliance in local labels, and impacts patient safety. Discover how a top biopharma cut translation times by an average of 75% using AI-powered automated translations with Vault RIM as context.
Discover how a biopharma 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.
See Veeva’s vision for clinical data in digital trials through an end-to-end demo spanning patients, sites, and sponsors/CROs. This live demo showcases what’s available today using Veeva’s EDC, CDB, RTSM, ePRO, CTMS, and Safety systems.
Discover the importance of a seamless partnership between Clinical Operations and Clinical Supply in optimizing trial efficiency and ensuring a positive site experience. Explore the critical touchpoints and collaborative efforts between trial operations and drug supply that are necessary to navigate the complexities of RTSM.
Leaders at two emerging biopharmas describe their journey to bring eTMF in-house, including moving processes into the system. They’ll also share tips for driving efficiencies with sponsor-owned Vault eTMF.
Top biopharma panel will discuss how they improved management of pharmacovigilance system master files (PSMFs), pharmacovigilance agreements (PVAs), and additional risk minimization measures (aRMMs).
A top biopharma describes how they replaced manual processes with Vault Study Training. They will share best practices to streamline and centralize training for research sites, CROs, and internal study teams and drive inspection readiness.
Accelerate business processes and improve user experience with the latest Vault capabilities.
Three emerging biopharmas will share their operating models and how they unlock faster, more efficient trials with Vault CTMS.
Tuesday, Sept. 10
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.
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.
Learn about the innovations and enhancements coming to Veeva RTSM, and ask the Veeva team questions during an interactive Q&A.
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.
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.
Join the Vault RIM product team to discuss any key features from the past year, the latest in regulatory guidelines and developments, and the future roadmap for Vault RIM.
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.
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!
Learn 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.
See how two top biopharmas 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.
Staying current with Vault RIM to deliver better outcomes among evolving regulations, operating models and organizational demands is not easy. Get practical guidance from two top biopharmas on agile release management, Center of Excellence models, and risk-assessment based validation of Vault RIM innovation.
Learn about the innovations and enhancements coming to Veeva ePRO and eClinRO, and ask the Veeva team questions during an interactive Q&A.
Learn about the innovations and enhancements coming to Veeva RTSM, and ask the Veeva team questions during an interactive Q&A.
Hear how two biopharmas 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.
Discover how an emerging biotech automated data flow between safety, clinical, and regulatory teams to reduce manual overhead, risk, and data reconciliation. Learn how they improved data quality by connecting systems across business functions and established a single trusted source of information.
A biopharma details their best practices to scale TMF operations across programs and CROs with Vault eTMF. They’ll also share their vision for additional growth in Vault Clinical Operations.
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.
Discover the latest Vault Connections and enhancements and see how they are transforming biopharma processes, improving data quality, and simplifying compliance.
This CRO shares how the study-locking capability in Vault CTMS enabled data migration without any downtime.
A top pharma shares the advancements in their quality complaints management, showcasing streamlined operations through an interconnected system. Discover how this enhancement improves workflow efficiency and streamlines issue resolution.
A global biopharma rapidly transformed quality systems and modernized the batch release process, elevating its global manufacturing and patient care. Discover how this strategic re-implementation, guided by Veeva’s best practices, ensures sustained growth and high-quality treatments worldwide.
Steve Gens explains what constitutes a high-performing regulatory organization based on a decade of research on world-class RIM operations. Four top-ranked biopharmas identified in the Gens & Associates benchmark will outline ways to achieve and sustain high regulatory performance.
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.
Get an overview on tools and resources to solve complex use cases for Vault Admins and Developers. We’ll review capabilities in Vault Admin UI, Vault API, and Vault Java SDK to help automate deployments, integrate systems, and extend the Vault Platform.