Situation:
A small biotech company, with a novel technology to develop, produce, and commercialize therapeutic proteins, was embarking on a global Phase 2-3 clinical program and was in need of a strong project manager for three global clinical trials, including vendor selection and management support. In addition to project management, the client also requested that Halloran conduct a Clinical Quality System Gap Analysis to ensure their system supported high quality, virtual, global clinical research practices.
Solutions:
- Halloran performed ongoing project management tasks including daily operational management, vendor selection, and oversight.
- Halloran evaluated the current Clinical Quality System and related documentation and provided recommendations to enhance/update the system.
- Halloran conducted interviews with staff (including Clinical, Finance, Quality, Program Management, Regulatory Affairs, and Safety) involved in the clinical research process to identify gaps and inefficiencies.
- Using a rating system that categorized the risks to the organization into "critical", "needed", and "nice-to-have", Halloran provided process recommendations to address gaps and lack of alignment with industry best practice.
Value:
The client received a summary presentation describing the key findings and recommendations for ensuring compliance and efficiency of the clinical research process. This client subsequently asked Halloran to assist in implementing the needed process revisions for the critical findings, including creating/revising specific Clinical Quality System documents such as Standard Operating Procedures, Quality Manuals, and others.