Description
This presentation will address conducting value added audits of technical service providers (TSPs) providing services for and/or in support of clinical trials and programs. TSPs would include those vendors that provide technology-based services to pharmaceutical, biotechnology, and medical device companies. These companies would include, but are not limited to Electronic Data Capture (EDC), Interactive Voice/Web Response (IVR/IWR), central electrocardiograph (ECG) reading, electronic Patient Reported Outcomes (ePRO), central imaging reading centers, etc. The presentation will cover the following subject matters: why we conduct audits of TSPs; the types of audits conducted of TSPs; the process of conducting value added audits (before, during, and after); and reporting processes.
Why you should attend: If you are involved in the processes of selecting, qualifying, auditing, and creating contracts with technical service providers you will be interested in learning why and how to conduct audits of technical service providers.
