Situation:
A global pharmaceutical company acquired a small biotech company with a novel product for seriously ill liquid tumor patients. Upon post-acquisition due diligence, the compliance issues identified in the mid-stream proof of concept trials were alarming, and the company felt the need to address them firmly with investigators.
Solutions:
- Halloran used audit findings to design a targeted physician Good Clinical Practice intensive training.
- Halloran delivered this training during a therapeutic conference at an off-site refresher program for physicians.
Value:
The pharma company's project manager was able to maintain a neutral role in the sensitive timeframe of project transition, while the company addressed compliance issues paying close attention to completing the proof of concept program with a strong focus on protocol compliance.