A Novel Approach to Provider Qualification
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.
