Regulatory inspectors increasingly scrutinize the selection, qualification and oversight processes of GxP service Providers in clinical research as there are many potential risks to data integrity, data interpretability or patient safety that can arise from insufficient qualification of a service Provider’s capabilities.
The first step to manage the risks associated with outsourcing clinical services is by careful assessment of service Providers’ capabilities, management and adherence to their processes, plus the experience of their team members. Evaluating these categories against a standardized set of criteria that are linked back to industry regulations and best practices is imperative to be able to identify the risks that will carry through into Provider selection and oversight. The qualification process can be very resource-intensive and can increase the lead-time to study start-up.
Furthermore, new and novel trial designs are increasing the number of service Providers in the market such as eClinical technologies which increases operational complexity and potential risk in trials. This webinar will explore how the burden can be lifted and time saved by using the Diligent Qualification Platform to assess service and technology providers against the standards developed by the WCG Avoca Quality Consortium.
Key Learning Objectives:
- The need for comprehensive qualification of service and technology providers in clinical research
- Industry leading standards for research developed by WCG Avoca Quality Consortium
- The advantages of a standardized approach to provider qualification for consistent and rapid assessment of service providers
- The support available for sponsors and CROs through the Diligent Qualification Platform, with risk scoring of Request for Information (RFI) answers and shared Vendor Qualification Assessment reports.
- How to leverage the risks identified in qualification to set your provider oversight plans.
