Harnessing the Strategic Value of the eTMF

At Veeva’s clinical roundtable event last week, representatives from 33 companies, including CROs, sponsors, and stakeholders from across the spectrum of clinical trials, came together with industry thought leaders in Philadelphia for an open, exciting dialogue. With our clinical roundtable, we wanted to provide a frank discussion about the dynamics of clinical trials, and how to harness the strategic value of the electronic Trial Master File (eTMF) in order to drive better operational efficiency, as well as previously inaccessible strategic insights. One theme held constant across the conversations: technology solutions must be part of a plan for creating true partnerships between sponsors, CROs and investigator sites.

Ken Getz of the Tufts Center for the Study of Drug Development noted that historically, CROs were perceived as commodity service providers that sponsors had to strictly police. Today, however, CROs are at the forefront of innovation in the life sciences, propelling the industry forward by seeking out new technologies for driving efficiencies within their own organizations. Progressive companies are leveraging CROs for the distinct benefits they offer, including faster cycle times. Getz sees the traditional sponsor-CRO paradigm beginning to shift from transactional relationships to integrated alliances, wherein technology provides the framework for effective collaboration between partners.

A panel of expert advisors to major life sciences companies and heads of clinical operations joined Ken in exploring the idea of thinking differently about eTMF solutions. An eTMF can help organizations understand and locate documents more easily, but it can be so much more than a purely functional tool. Creating, exchanging, and approving documents within a shared eTMF opens the lines of communication and strengthens alliances. When all parties share access to a single system, the technology itself can help foster a culture of cooperation.

Often, according to Linda Sullivan of Metrics Champion Consortium, sponsors do not give CROs enough control to allow them to do their jobs. When it comes to examining metrics, she says, it is important to clearly identify those metrics that are likely to have impact on desired outcomes, such as faster study and site start-up times, better inspection readiness and greater process efficiency. Also, when working with CROs, it is important to share those metrics, desired outcomes, and results directly with the trial teams, both sponsor and CRO.

Innovative technologies provide us with the opportunity to streamline clinical processes and – perhaps most importantly – build strong relationships across sponsors, CROs and sites. We hope to continue to provide forums for clinical leaders to come together, so that these important conversations can continue. Plan to attend our next Clinical Roundtable in Boston on November 14 for more discussions, networking opportunities, and game-changing insights.

Jen Goldsmith is VP, Veeva Vault at Veeva.