Collaboration and Trial Performance are Top Priorities for Clinical Operations

Enhancing collaboration and improving trial performance were key themes for more than 375 clinical operations professionals that gathered at the sixth annual Veeva R&D Summit in Philadelphia last week.

Doug Schantz, executive director of development operations at AstraZeneca, kicked off the clinical operations track by discussing AstraZeneca’s journey to streamline study execution and improve collaboration with study partners. Their approach was two-fold – business process reengineering, supported by a technology transformation initiative – which enabled them to collaborate more closely with sites, decrease non-enrolling sites, and achieve recognition as sponsor of choice from SCRS.

The importance of streamlining collaboration with study partners was echoed by Allergan and Johnson & Johnson. Lorena Gomez, director of global study start-up at Allergan, and Sandy Freeman, director at Johnson & Johnson, emphasized the value of unified clinical applications to improve collaboration with sites and reduce time to site activation. After moving to a purpose-built study start-up application, J&J decreased time to gather essential documents from sites by 70%.

Summit attendees heard the site perspective on collaboration and information sharing from the University of Louisville. Lale Akca, executive director, and Rachel Sheppard, clinical regulatory director, spoke about their goals to improve study quality, speed, and compliance through the use of site-specific technology. Process efficiencies driven by technology allow the university to get trials up and running quicker and make it easier for sponsors to work with them.

Jamie Toth, head of TMF operations at Daiichi Sankyo, believes listening to all stakeholders is key when striving for TMF compliance. She shared best practices and tips for engaging internal and external teams to ensure alignment on changing regulatory and business requirements. She also highlighted the importance of setting a clear change control process – with structured approval – in order to drive continuous process improvement.

This sentiment was echoed by Alkermes’ Kate Santoro, senior clinical trial manager, who highlighted how their approach to working collaboratively with CROs improved trial execution. Alkermes’ CRO partners played an active role in their eTMF system configuration and continue to provide input on monthly metrics reviews.

This year’s Summit encouraged peer learning and best practices discussions. We’re looking forward to seeing how this knowledge-sharing drive the industry forward.

Pre-register now for the 2020 R&D Summit in Boston October 12-14.