When outsourcing services or technologies in support of clinical trials, the most efficient use of resources and time available is to use a risk-based approach for the qualification of service providers.
However, for many clinical trial sponsor companies, developing an effective risk-based approach to service provider qualification can feel overwhelming and fraught with potential regulatory compliance / inspection risks, timeline delays and complex vendor selection decisions.
The solution is to adopt an enterprise framework and approach that incorporates risk-based attributes for service provider pre-qualification, performance oversight and audit. This comprehensive approach can be scaled and applied to all phases of clinical research, all capabilities / technologies to be assessed, and all geographies for your trial.
This webinar will share practical advice from experts with experience from within trial sponsors on how to implement such an enterprise framework, and will cover the information resources available to cut the work required.
All our speakers currently work with a clinical trial sponsor and/or have 25+ years of outsourcing experience within trial sponsors.
Learning Objectives:
- The risks of ineffective qualification of service or technology providers for clinical trials
- What an effective enterprise framework of risk-based attributes looks like
- Practical advice on how to implement such a framework in your organization
- An explanation of the information and tools available from Diligent Pharma
