CRO Rescues Multi Study Program Utilizing EDC Solution

Statistics & Data Corporation (SDC), a specialized biostatistics and clinical data management contract research organization (CRO), was recently approached by a biotechnology company to discuss a rescue scenario for two pivotal trials running in parallel.

Some of the unique challenges associated with this rescue program included:

• An aggressive transition schedule to maintain predetermined study enrollment and randomization requirements
• Rapid, dual study developments running in parallel
• The need for additional clinical operations support required to supplement the sponsor’s internal resources

Understanding the unique characteristics of this rescue program and the importance of the two pivotal studies for the sponsor, SDC confidently committed to taking over the development of the clinical study databases utilizing MedNet Solutions’ iMedNet, a fast and flexible EDC/eClinical technology platform that allows for rapid and efficient study creation.