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