Phase III Rare Disease Rescue

A small biotech with limited internal capacity outsourced a phase III clinical program in patients with Necrotizing Soft Tissue Infections, a rare, life threatening infection for which no therapy currently exists, to a CRO. The study was to be conducted with 60 US sites with the objective of enrolling 290 patients.

After nearly 16 months, patient enrollment was still a major challenge and the CRO was not proactive in addressing the issues and providing solutions. Adding to the difficulties, the study was over budget and CRO staff turnover on the project was extremely high. The CRO-Sponsor relationship had deteriorated significantly. The Sponsor wanted control back.