Situation:
Halloran was asked to conduct a Gap Analysis on a Phase 3 clinical study for a biotech company. The trial was 12 months old and already running six months behind schedule on site activation and patient recruitment.
Solutions:
- Halloran utilized a team of Clinical Operations and Regulatory Affairs experts to interview key team members and clinical sites, assess the protocol and study tools, and evaluate the resources devoted to the trial.
- A summary of findings and recommendations was presented to the company's Board of Directors, including key hires to augment internal staff focused on running the program, methods for supporting site activities to drive patient recruitment, and strategies for managing the budget and activities of the key CRO.
- Interim management was provided by a senior Halloran staff member to oversee the implementation of the recommendations.
Value:
In the first six months, two key internal staff members were hired to focus on the study. Direct communication with each clinical site resulted in adoption of site specific recruitment strategies. Significant personnel changes were requested from the CRO and the trial completed on schedule.