See if this sounds familiar: You select a CRO to perform your clinical trial. You send them a package which explains the case report form, the database structure, required edit checks, and additional expectations you have. Despite all of your preparation, when the trial is complete you find the CRO did not follow your standards, did not properly implement edit checks, and/or submitted a database structure not compatible with yours. As a result, the data quality suffered.
Most Big Pharma firms outsourcing clinical research could probably share a data horror story or two. As the head of global data management at Bayer Healthcare, Johann Proeve and his team are accountable for the quality of the data from outsourced trials. After witnessing a few worst case scenarios himself, he knew something had to change.
“When Bayer began to outsource its clinical trials, it quickly encountered problems with managing some CROs,” he says. “The problems dealt with clinical data management, programming, study management review, and more. We needed a way to improve the situation, particularly with respect to streamlining certain processes.” One of the success stories to emerge from that process was a partnering agreement with Covance, which Bayer now uses as a role model for how to successfully execute partnerships.