Trial Efficiency and Collaboration Key Topics at 2020 Veeva R&D and Quality Summit
We were honored to welcome nearly 800 people to the clinical operations track at this year’s Veeva R&D and Quality Summit Online. Industry experts from eight life sciences companies – both small and large – shared their experiences streamlining clinical operations to increase efficiency, quality, and speed in clinical trials.
Modernizing Clinical Trials
Anders Persson, a digital transformation leader at AstraZeneca, kicked off the clinical operations track by detailing AstraZeneca’s multi-phase deployment and change management program to transform clinical trial operations globally – across 40 countries and 3,000 users, with eight million records migrated for 1,350 studies – in 16 months. They outlined their vision, strategy, and implementation approach as well as the positive impact of a unified clinical landscape on global study execution. Hear more in an encore presentation with AstraZeneca on January 21, 2021.
As highlighted in the Veeva 2020 Unified Clinical Operations Survey Report, unifying clinical operations is a top priority for improving trial performance. This view was echoed by Marc Nephtali, Jessica Skrine, and Garrick Myers from Vertex Pharmaceuticals, who modernized its operating model by unifying clinical systems throughout the enterprise. They shared Vertex’s complex and accelerated implementation timeline, key measures of success, and lessons learned along the way.
Jess Robinson from GSK discussed the importance of aligning people, processes, and technology to achieve a unified clinical environment and speed study execution. Jess shared change management techniques that enabled a successful global launch of Vault Study Startup and best practices for managing multiple Vault applications.
Active TMF Management
Summit attendees heard about the benefits of active TMF management in improving TMF quality. Leila Ponce, clinical trial manager from Seagen, explained how metrics, dashboards, and reports built within Veeva Vault eTMF are used to maintain an ongoing culture of inspection-readiness, and subsequently, helped the TMF team prepare for, and pass, an inspection.
Jessica Vicari, director of clinical digital solutions from Immunomedics, shared their best-in-class TMF management processes and how they used a people-process-technology framework to enhance their TMF operations.
Leveraging Vault eTMF to streamline TMF processes and improve inspection readiness was a priority for JC Sheridan and Heather Frankhouser from J&J Innovative Medicine. By bringing together both essential and non-essential trial documents that were previously managed across multiple systems, they were able to more clearly tell the full story of a trial.
Streamlining Information Sharing and Collaboration
Current technologies provide the opportunity to transform trial execution through simplifying and streamlining the flow of information between studies partners, as Julie Saathoff, executive director at Celerion, elaborated. As an early adopter of Veeva Site Connect, Julia discussed their vision to streamline how information is shared during clinical trials. She outlined how Celerion is leveraging Site Connect to eliminate manual processes, improve study quality, and increase site engagement by automating the flow of trial information across systems, processes, and study partners.
Jeff Wiley, head of global clinical project delivery at Covance, broached the difficulties in monitoring and source data verification (SDV) activities once COVID-19 hit. He spoke about how they dealt with this situation specifically, encouraging their sites to use Veeva SiteVault to not only manage site processes but also support easier remote monitoring and document transfer during the study. This allowed Covance to keep their trial on track with minimal delays, despite the challenges posed by the pandemic.
This year’s Summit encouraged peer learning and focused on thought leaders in clinical trial operations. We’re looking forward to seeing how this collaboration and knowledge-sharing drives the industry forward in the coming months. To view the presentation portion of these sessions on-demand, please register here.
Join us for an encore webinar to hear more from AstraZeneca about their clinical transformation journey.