Situation:
A mid-sized pharmaceutical company preparing to begin a global, pivotal clinical program for their key product needed an assessment of organizational compliance and readiness. The program was highly complex with >10 vendors and over 100 sites in 12 countries. The program relied on vendors for almost all clinical activities, yet the company had no standard vendor selection and management approach. The quality assurance group was not staffed or trained to support a large, global clinical program. Clinical operations staff struggled with unclear roles, sub-optimal communication, and lack of project governance processes.
Solutions:
- Halloran identified organizational and quality systems gaps which presented operational and audit risks to the pivotal program and developed a prioritized remediation plan.
Value:
Clinical leadership was able to address the gaps, mitigating risk of operational failure and serious audit findings that could have delayed a key program and associated market entry.