Three Lessons in Supporting a Diverse Client Population – A CRO Perspective

November 27, 2013

  • eTMF Best Practices

Last week, Wingspan attended the 14th DIA Conference on European Electronic Document Management in Dublin, Ireland.  On the second day of the conference, Wingspan CEO, Troy Deck presented with ICON Program Manager, John Blunden on the Collaboration Panel lead by Dimitri Stamatiadis, PhD, MBA, of MAIA Consulting SARL.  The session included topics such as validation and document collaboration, but Mr. Blunden and Mr. Deck focused on CRO collaboration with clients, and also with technology vendors.

Three key points emerged from this part of the session as challenges facing a CRO when implementing the use of an eTMF.

Meeting the needs of specific sponsors

John Blunden cites figuring out what should be in each specific trial master file as the biggest challenge that he faces at ICON.  While adoption of the TMF Reference Model has assisted greatly in determining a general document list, specifications still vary by sponsor.

Using eTMF as a competitive advantage

ICON has learned that the best way to compete is to “make it easy” for clients.  They hope to use the eTMF to facilitate the study at every stage, included providing easy access to reports and metrics for sponsors. Moreover, with continued use of the eTMF, ICON enhances their expertise and knowledge acquired from previous studies. Eventually, they’ll be able to deliver an experience- sharing best practices and integral data.

Navigating relationships with technology vendors

ICON and Wingspan have seen the mutually beneficial relationship of selecting a SaaS provider first-hand.  With continued subscription renewal, ICON continues to invest in the product and contribute to the product roadmap; therefore, Wingspan can continue to develop the eTMF and add new features and functionality.  At the same time, Wingspan is motivated to work hard to contribute towards Icon’s success on an ongoing basis.  Both parties have shared motivations for the success of the software, which leads to a collaborative environment.

To request a copy of the slides from the presentation, “ICON and eTMF: Supporting a Diverse Client Population,” please email Meghan McKeown at mmckeown@wingspan.com.