Phase IIIb Diabetes Case Study

SITUATION

A sponsor approached CRMG with a first in class diabetes drug that was initially denied approval by the FDA.  The FDA required a large safety study be performed, given concerns over cardiovascular risks for the product.  Timelines were extremely tight.  CRMG’s job was to initiate a new study, identifying new investigators and convincing prior investigators to participate in a study amidst this additional safety scrutiny.  Given the required sample size of patients (3,400) and timing, the sponsor chose a three-pronged approach, splitting US enrollment between CRMG (1,200 patients) and a non-traditional institutional contractor (1,100 patients) while simultaneously involving a large global multi-national CRO for the remaining 1,100 patients in the rest of the world.

SOLUTION

1. A novel approach:  With all hands on deck, the CRMG team reached out first to key opinion leaders (KOLs) across the country and, in concert with our sponsor, educated them on the safety data behind the compound. Maximizing our relationships with these KOLs, we achieved buy-in and leveraged them to further educate and persuade other investigative sites to join the study. By getting these KOLs on board, CRMG had the necessary traction to meet the very aggressive goals. 
2. Agility when it counts:  Our project manager, monitors and support staff were readily available to educate and provide guidance to sites, driving self-monitoring habits, and motivating the Investigators and their staff to drive enrollment for this important new therapy.  Empowered to make decisions and unencumbered by long processes, our nimble team of 15-20 dedicated and personally invested professionals outperformed our peers, meeting our enrollment goals a full 5 months ahead of schedule.  
3. Tenacity when it matters:  Efforts that are typically done sequentially, we managed simultaneously – cleaning and vetting results as the data came in. The CRMG team was on the phone constantly, quickly solving and managing situations before they swelled out of control. This saved us time in cleaning the database, allowing us to lock the database quickly upon the last subject’s final visit.
4. Continuity, commitment and knowledge:  Every member of the operational team who began the study was part of the team at completion 15 months later. This continuity was another built-in efficiency, eliminating training of new personnel and potential errors associated with discontinuity.  Further, the knowledge of the team was leveraged by the sponsor when compiling their NDA package, as this team knew the full clinical story of this product - not only from this study, but from prior studies on this product as well.

Results

At the outset, our goal was to enroll 1,200 participants in the first year. We reached that goal in only 7 months.  Given the lack of success in this area from our peers, the sponsor empowered CRMG to take over the global management of the study, which included CRMG’s personal efforts to enroll an additional 1,100 patients in the US over the following 8 months.

The database of some 3,400 participants was cleaned and locked within two weeks of the study’s end. We credit our incredible, resourceful team with this unprecedented result

We understand that in our business, the solutions are many times the same – it’s the execution that makes the difference. In this case, it couldn’t be truer.