*Times listed are EDT
*Times listed are EDT
AstraZeneca: A Vision for a Collaborative Clinical Environment
After receiving the 2018 Eagle Award for the best sponsor by the Society for Clinical Research Sites (SCRS), AstraZeneca is on an ongoing quest to remain a sponsor of choice for 2019 and beyond. Learn how they are leveraging technology, a unified clinical trial platform, and other strategies to simplify trial conduct at sites.
Alkermes: Improving TMF Quality and Oversight with Effective Collaboration
Implementing a team-based approach has enabled Alkermes to enhance the quality and oversight of their TMF. They'll detail how they improved trial execution and collaboration internally and across multiple CROs through active TMF management and oversight.
Daiichi Sankyo: Best Practices for Governing eTMF Changes
Discover how active TMF management and oversight allows Daiichi Sankyo to update their eTMF to support changing business and regulatory requirements. Learn best practices for engaging cross-functional teams when implementing eTMF changes.
Veeva Vault for Clinical Transformations
Accenture will detail how to define business drivers and implications for transforming clinical development operations with the Veeva Vault Clinical Suite. Using real-world customer examples, they will also offer tips on understanding the impact on business processes and existing clinical technology landscape.
Lilly: Improving Transparency, Oversight, and Quality of Clinical Trial Processes
Hear Lilly’s strategy and implementation considerations for optimizing processes using Vault eTMF. Learn how the use of milestones and expected document lists have improved transparency, oversight, and quality control across their global clinical development.
Eli Lilly: Our Vision and Strategy for Transforming Clinical Data Management
Lilly is partnering with Veeva to transform clinical data management. They’ll describe plans and critical success criteria for deploying Vault EDC enterprise-wide. Collaborating on the development of Vault Data Workbench creates the foundation for the future state in data sciences.
Customer Session: Harmonizing and Centralizing Audits and Quality Management
An increasingly complex global environment is driving unification of quality systems to increase efficiency and visibility into risk. See how this company leveraged the delivered Vault QMS application for a successful global audit program, and is used to harmonize processes and consolidate systems across multiple lines of business.
Cara, Penumbra, Lotus, Immunomedics: Building and Running Clinical Trials with Vault EDC – Lessons Learned
Hear first-hand stories about building studies, cleaning data, and tracking status with Vault CDMS. Panel topics include the QuickView interface for CRAs, using Vault Coder, operational reporting, and executing protocol amendments.
Samsung BioLogics: Vision for Modernizing Manufacturing Quality
Samsung BioLogics is leveraging modern quality solutions to enhance business capabilities that can better meet the highest global standards and diverse customer demands. Get an overview of Samsung’s vision and their approach to implementing innovative technology to transform pharmaceutical manufacturing.
Roche Diagnostics: Harmonizing and Centralizing Audits and Quality Management
An increasingly complex global environment is driving unification of quality systems to increase efficiency and visibility into risk. See how Roche Diagnostics leveraged the delivered Vault QMS application for a successful global audit program, and is used to harmonize processes and consolidate systems across multiple lines of business.
Foamix: Strengthening Quality Management with Vault Training
Extending Vault QualityDocs with Vault Training enables automation of curriculum development and training assignments. We’ll discuss how Foamix configured Vault QualityDocs, and benefits from empowering learners and managers with training visibility such as faster access to trained material, increasing compliance, and supporting self-driven continuous learning.
PRA Health Sciences: Unifying Quality Management
PRA has embarked on a multiphase project to replace multiple legacy systems and processes with a unified Vault solution, leveraging QMS and Vault QualityDocs. Supporting a range of regulatory requirements and a global user base, PRA is improving the quality management experience and gaining greater alignment with Clients and Industry expectations. Learn about their deployment approach – continuing to allow changes after go-live, and how they are continuing to improve functionality and processes, including the provision of external user access.
Celularity: Driving Efficient Audits and Inspections with Vault QMS
Audits and inspections at many companies are inefficient and require a lot of manual overhead. Learn how Celularity is approaching audits / inspections – including checklists prior, during, and after the event as well as roles and responsibilities for the front and back room. They'll also discuss how Vault QMS streamlines preparation and response to audits / inspections and supports continuous improvement.
Gilead: Successfully Expanding Vault QualityDocs Across the Global Enterprise
Gilead replaced their enterprise document management system with Vault QualityDocs, migrating content and processes into the Vault they use for partner collaboration. They now have a single application supporting partners, multiple internal sites, and newly acquired Kite. Learn how they harmonized processes globally and leverage Vault capabilities such as dynamic access control to minimize maintenance and achieve greater scalability.
BMS and PwC: Transforming the Role of Quality with Digitalization
Bristol-Myers Squibb and PWC explore transforming quality from compliance-centric to product and patient-centric as well as elements for successful change. Sharing BMS’ journey to digital quality, they’ll discuss how Vault QMS is implemented to manage complex, GxP quality processes across the enterprise - optimizing processes, reducing risk, and improving transparency. We’ll also hear how to build a foundation to enable growth and increase operational performance through advanced processes and technologies such as AI.
Celgene: Accelerating Global Deployment of Vault QualityDocs
Deploying a quality content management system at an enterprise scale requires excellent communication and coordination across multiple teams. Celgene shares how to accelerate the deployment of Vault QualityDocs and their vision for global quality risk management.
Blueprint and Vericel: The Evolving Role of Regulatory Operations
The role of regulatory operations is becoming more strategic and now requires a broader set of skills. Hear two innovative leaders from Blueprint and Vericel discuss how they are embracing this shift with a modern, unified RIM solution that enables them to move faster and be more productive.
TESARO a GSK Company: Driving Continuous Improvement with Vault RIM
Through the adoption of Veeva Vault RIM, Tesaro enabled a series of behavior changes that unlocked opportunities across the organization. Learn how they brought together people, process, and technology to drive rapid innovation and create incremental value for their business.
Vertex: Achieving Greater Value with End-to-end RIM
While searching for a leading-edge regulatory EDMS, Vertex realized they could solve a bigger challenge by adopting the shared data model within a unified RIM platform. Hear how they reset expectations, persuaded management, and aligned regulatory operations with their commitment to patients.
Melinta, Regenxbio, and Myovant: Vault Submissions Publishing in Action
With hundreds of FDA submissions now complete, Melinta and Regenxbio will share how they successfully transitioned from traditional, serial publishing to a more streamlined, continuous approach. They will be joined by Myovant that recently adopted Vault Submissions Publishing to prepare a major filing.
Valiance: A Roadmap for Vault RIM Migration
Migrating global data and content into a RIM system depends on many factors including company size, geographic system dispersion, and past M&A activity. Valiance will present lessons learned for RIM migration as it relates to data quality remediation, automated data classification, iterative functional dry runs, archive, automated migration testing, and data harmonization.
Agios and Amicus: Managing Health Authority Interactions in Vault RIM
Agios and Amicus maximize their use of Vault RIM by leveraging commitments, health authority questions, and correspondence tracking. Discover how they implemented these features, modernized their existing RIM processes, and successfully managed change along the way. They’ll also review best practices, adoption monitoring, and plans for future enhancements.
Veeva Session: Evaluating the Tangible Benefits of Vault Clinical Suite
Based on real-world scenarios and Veeva’s value engineering model, learn how to identify areas for process improvement, key performance indicators, and the value realised from streamlining end-to-end clinical trial processes.
Veeva Session: Best Practices for Vault Reporting and Dashboards
Make informed decisions with visibility into operational processes, application usage, and other management KPIs. See how to use flash reports, scheduled reporting, and dashboards to determine information such as cycle times, overdue processes, and user access. We’ll also explore what’s coming in the roadmap.
Veeva Session: Extending Vault with Advanced Object Configuration and Business Programming
IT professionals familiar with Vault Object configuration and basic programming can learn how to extend Vault to deliver specific business rules and a more controlled user experience. We’ll demonstrate how to apply custom business logic inside Vault and from external systems using advanced object configurations, SDKs, and APIs.
Veeva Session: Microsoft Office and Vault
Microsoft Office is the leading authoring environment for R&D documents. Vault integrates directly with Office across the platform to easily consume and construct documents. This session will review how Vault integration with Microsoft Office streamlines content development and approval. We’ll also explore new features such as collaborative authoring with Microsoft Office.
BMS: Enterprise Platform Management at BMS
An effective governance model enables BMS to strategically implement release-cycle enhancements across Vault applications, while at the same time ensuring data integrity, business rule implementation, and use of resources in an agile manner. Hear how they leverage Veeva’s maturity model framework, industry KPIs, health check analysis, and a global governance process to optimize Vault capabilities across the enterprise.
Deep-dive and Roadmap: Multi-document Workflow
Vault lifecycles and workflows are critical to supporting regulated processes. Many times these processes revolve around sets of related documents. Hear case studies on key business challenges and how Multi-Document Workflow was configured to solve them. We will cover recently released features and what's coming in the roadmap.
Veeva Session: Best Practices for Vault Platform Security and Access Control
Learn how customers leverage Vault security capabilities such as dynamic access control, atomic security, and restricting access by user roles and lifecycle states to enable more control, greater scalability, and easier collaboration across sites and partners.
Gilead: Implementation and Integration Best Practices for GxP Systems
Learn Gilead's best practices for implementing and integrating Vault with other applications like identity management for automating user access and learning management. Hear their methodology for developing and maintaining integrations in a validated environment. And find out how they expanded Vault to new areas while supporting their existing system for partner collaboration.
Vault Roadmap and Vision: Clinical Operations - Vault CTMS, Vault eTMF, and Vault Study Startup
Learn about key enhancements for the clinical operations suite of applications including Vault
CTMS, Vault eTMF, Vault Study Startup, SiteVault, and the Veeva Clinical Network. For business and IT.
There will be a 15 minute break at 12:00 p.m.
Vault Roadmap and Vision: Clinical Operations - Vault CTMS, Vault eTMF, and Vault Study Startup.
Learn about key enhancements for the clinical operations suite of applications including Vault CTMS, Vault eTMF, Vault Study Startup, SiteVault,and the Veeva Clinical Network. For business and IT.
ICON, Lotus, and Bioforum: CRO Perspectives on Vault CDMS
CROs share their perspectives on the build process with Vault CDMS, saving time with QuickViews, operational reporting, and simplifying the validation process. Hear about their experiences with enablement and learning to build with Vault Studio.
Deep Dive: Supporting Complex Studies with Elegant Designs and Easy Integrations
Veeva shares techniques to accommodate advanced study designs while driving down build and casebook complexity. Real-life examples illustrate how Vault CDMS supports patient cohort branching, treatment cycles, and system integrations.
Dicerna, Foamix, Xencor, and Xeris: Simplifying Training Development and Delivery
With more learners wearing multiple hats and increasing complexity of qualification- and compliance-related controlled documents, companies need an efficient way to deliver and manage training. We’ll discuss how Vault Training simplifies training development and delivery processes and is implemented.
Roadmap and Vision: Vault QualityDocs, Vault Station Manager, and Vault Training
Learn about new features in Vault QualityDocs that mitigate risk across the organization. See how Vault Station Manager, a tablet application, simplifies the job of document controllers and manufacturing operators. We’ll also demonstrate how Vault Training improves training effectiveness and discuss upcoming enhancements, such as classroom and multi-item training.
GSK: Lessons Learned Moving to Global Unified RIM
GSK is on a multi-year transformation to unify regulatory processes across three major business areas. Hear an update on their regulatory journey, how they’re leveraging Vault RIM to seamlessly integrate teams in different countries, and what best practices they’ve learned along the way.
Vault Roadmap and Vision: Registrations
Explore how Vault Registrations manages global complexity through enhancements to the bundling process, connectivity with QMS through the Spark framework, and support for medical device registrations. Learn about future IDMP capabilities and planned features for early 2020.
Vault Roadmap and Vision: Submissions, Submissions Publishing, and Submissions Archive
Learn about key Vault Submissions enhancements such as improved content plan usability, document linking and navigation, and integration with Vault eTMF. We'll preview the Vault Submissions Archive and Vault Submissions Publishing roadmaps including simplified import and export of submissions, dossier review, and future support for publishing in additional eCTD regions.
Vault Roadmap and Vision: Safety
Join us to hear Veeva’s vision for Vault Safety, a comprehensive solution to manage the end-to-end safety lifecycle, from case intake and adverse event processing to authoring and submissions. We will present the Vault Safety roadmap and provide a clear path to an enterprise-ready global safety application. Also, get a sneak peek at the new artificial intelligence solution and see a visionary demonstration of Vault Safety.
Veeva Session: Flash Reports and Multi-pass Reporting
Flash reports and multi-pass reporting enable users to deliver KPIs directly to inboxes, view large reports in seconds, and build powerful reports that span deep into data models.This session will review how to configure flash reports and multi-pass reports for real-world use cases, while touching on potential pitfalls admins may encounter. We will also explore what’s coming on the roadmap.
Veeva Session: Managing Vault Environments with Vault Tools
Understand available tools and best practices for managing Vault environments to save time and reduce risk. Hear about approaches and tools used to streamline implementation, testing, and compliance. We'll also demonstrate features such as sandbox Vaults, datasets in configurations migration and reporting, and explore the roadmap for Vault environment tools.
NNIT: Continuous Improvement With a Unified Cloud Platform
With unified applications, regulatory, clinical, and quality teams benefit from greater transparency, improved data quality, and enhanced user experience. More importantly, they gain a platform that stays current with regulatory requirements and releases new capabilities three times per year. In this session, NNIT discusses how to transition to a unified Vault platform and leverage release cycles to maximize your investment and ensure continuous improvements and business support.
AWS and BMS: How Bristol-Myers Squibb Drives Efficiency, Cost Savings, and Innovation in the Cloud
The increasing volume of data available to pharmaceutical companies creates pressure for R&D teams to organize and analyze that data to improve outcomes for patient health. By leveraging cloud technology to create, store, integrate, and orchestrate into data lakes, companies like Bristol-Myers Squibb (BMS) have achieved new efficiencies and cost savings. Hear BMS share their lessons learned from integrating Veeva platform into their eco-system and their leap towards Enterprise Data Lake on AWS.
Driving Efficient Monitoring in Vault CTMS
Learn tips and tricks to improve monitoring and study management in Vault CTMS, including how to automatically surface follow-up items, utilize monitoring reviewer comments, eSign monitoring events, and use monitoring event data in reports/dashboards to optimize your monitoring process.