Sponsored

Advancing a Diabetes Multi-Registration Program

Case Study

A large pharmaceutical company asked Covance to support their studies for a diabetes Phase III program specifically to register a drug to treat Type 2 Diabetes.Covance_Side_Image

Understanding the Challenge

Covance needed to recruit 2,700 patients across the world in the extremely competitive arena of diabetes studies. In addition, the sponsor wanted to get all the sites up and running as quickly as possible while employing cost-effective measures.

Tapping into Covance Central Laboratory Investigator Performance Database®

To meet the tight deadline and cost concerns, Covance relied on our rich central laboratory services database which includes more than 175,000 unique investigators and 15,000 protocols. Covance generates more clinical trial data than anyone else in the world.

Using the global Central Laboratory Services data, we are able to see which investigators consistently outperform their peers over time. The team focused on investigators in the top quartile for enrollment in diabetes. The data also revealed that some investigators had the capacity to execute more than one study consecutively. Given that the sponsor needed to run a suite of studies, Covance prioritized those investigators that could manage multiple studies at the same time.

*Protocol Finalization to First Patient In.
*Protocol Finalization to First Patient In.

Optimizing Extensive Feasibility Outreach

With the Covance Central Laboratory historical performance database, the team could discern which sites and investigators would best support the sponsor’s global registration trial – saving the sponsor cost and time. This unprecedented level of feasibility outreach and site capacity assessment allowed effective overlapping of sites across the program. As a result, the sponsor experienced accelerated site startup, a key factor to trimming overall clinical costs.

Covance Central Laboratory Historical Performance Data Helps Sponsor Meet and Exceed Key Milestones

Leveraging this robust, vast dataset made a significant difference in the study startup phase. Covance helped the sponsor achieve first patient in (FPI) ahead of schedule for all studies in the program and beat historical industry performance across a number of key metrics:

  • Reduced the time from final protocol to FPI by 18%
  • Experienced 41% fewer non-performing sites than industry diabetes studies
  • Enrolled 31% more patients/site/month than the original timeline

As a result, Covance helped reduce costs, accelerate the timeline and impact the return on investment.

Real Impact

 

 

www.covance.com/realimpact

Covance Inc., headquartered in Princeton, NJ, USA, is the drug development business of Laboratory Corporation of America Holdings (LabCorp). COVANCE is a registered trademark and the marketing name for Covance Inc. and its subsidiaries around the world.

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This article was created in collaboration with the sponsoring company and our sales and marketing team. The editorial team does not contribute.