A Unified Clinical Environment Improves Trial Performance

Unifying clinical systems and improving cross-party collaboration were the dominant themes for more than 270 clinical operations professionals that participated in the fifth Veeva R&D Summit earlier this month in Philadelphia.

Industry experts from Janssen, Syneos Health, and IACT Health kicked off the clinical operations track by discussing opportunities to transform trial execution through greater collaboration. Read Jason Methia’s blog to learn key insights from the track keynote.

Moving from a legacy solution to a modern clinical trial management system (CTMS) was a priority for Angela Todd, director of global development systems at Regeneron. After moving to a fully outsourced CRO model, Regeneron found it difficult to achieve effective oversight and visibility. Angela shared how Vault CTMS will enable Regeneron to fulfill sponsor oversight obligations, meet ICH E6 (R2) compliance, and improve trial performance.

While Regeneron leveraged a fully outsourced CRO model, Incyte, another rapidly growing biotech company, brought clinical trial operations in-house to speed study start-up and site activation.

Jennifer Heckman, head of Incyte’s Clinical Trial and Logistics group, emphasized the value of a unified clinical operating model to streamline processes, improve collaboration, and visibility – highlighting real-time information access as a critical success factor. Incyte is a “young, lean, and innovative organization,” said Jennifer Heckman. “For study start-up, we were looking for a tool with built-in intelligence and easy to use workflows. Another key criterion was integration with existing CTMS and eTMF applications. With Veeva, our stars aligned.”

Alignment and streamlining collaboration across study partners has become critical as trial complexity and demands on speed increase. Ora, Integra, and ARG shared their CTMS transformation journeys and tips to improve trial management and cross-party collaboration.

As highlighted in the 2018 Veeva Unified Clinical Survey, companies are looking for more advanced, purpose-built systems to improve clinical operations. This was a view mirrored by Abbvie’s Karen Whitson, who played an essential role in building an active, event-driven eTMF to tell the full story of a trial. Session attendees benefited from the lessons learned while implementing a modern eTMF solution. Allakos’ Brent Sorrells shared similar views on how a modern eTMF approach helps with inspection readiness. He advised communicating with all relevant departments ahead of time and organizing mock inspections to help prepare.

This year’s Summit brought more than 1,400 life sciences professionals together, enabling peer learning and best practices discussions. We’re looking forward to seeing how this collaboration and knowledge-sharing drives the industry forward in the coming months.

Click here to watch the highlights from this year’s General Session.