Key Take-Aways from CBI’s Sponsor/CRO System and Business Process Integration

November 28, 2012

  • eTMF Events

With more collaboration between CROs and Sponsors in the world of Clinical Trials, many have questions concerning systems and business process integration.  How can you maintain an effective partnership? Which party’s policies take precedent when a Sponsor outsources a trial to a CRO?  Can partnerships create a visible cost and time savings?  On November 15-16, 2012, CBI’s Forum on Sponsor/CRO System and Business Process Integration attempted to explore and answer these questions and provided insight for effectively accessing and managing Clinical Trial Information and Data while executing trials.

Three key take-aways from the forum surfaced:

  1. Treating the Sponsor/CRO relationship as a Vendor/Supplier relationship
  2. What systems should be used to complete the study: specifically, which eTMF system?
  3. How do industry initiatives like TransCelerate affect Sponsor/CRO business process integration?

Jacque Osmian, IT Senior Program Manager, Data Management at Medtronic, Inc. presented a case study on Best Practices for Communication, Data Sharing and Effective Partnership Management late Thursday morning.  The session helped identify communication practices that help sponsors ensure effective collaboration.  One of these suggestions included treating your CRO as a trusted supplier with dedicated internal resources, effective governance and defined/measurable criteria for success.

The second half of day one focused on leveraging technology to manage clinical trial information.  Discussed in two of the sessions, electronic trial master files (eTMF) remain a hot topic in clinical trials; moreover, the forum highlighted the challenge of choosing which TMF to use, the Sponsor’s or the CRO’s. This discussion is sure to continue as the use of eTMFs expand in the industry.  Wingspan’s Troy Deck spoke regarding how eTMF and CTMS systems can work together to help Sponsors and CROs work in harmony.  His presentation is available here.

Lastly, the function of TransCelerate surfaced multiple times over the two days.  As Applied Clinical Trials blogger, Lisa Henderson tweeted on Friday afternoon, “TransCelerate has been mentioned a lot as a way of getting through inherent inefficiencies and improving CRO/Sponsor bpi.”  With its five initiatives for improving the clinical trials process, TransCelerate could change the standards for which CROs and Sponsors interact with each other when conducting trials.