Outsourcing


IN- & OUTSOURCING STRATEGY
•  Develop an outsourcing strategy fulfilling both the operational and the company needs
•  Determine the in-house core competencies
•  Assess the needs, decide the model and select the best partner

CRO SELECTION PROCESS
•  A step-by-stepwise plan is essential to select the most appropriate CRO for your operational needs
•  Detail selection criteria(s)
•  Request for Information (RFI)
•  Request for Proposals (RFP)
•  Evaluate proposals in a systematic way
•  Select and document selection
•  Document the outsourcing processes in SOPs or Work Instructions (WIs)

CRO OVERSIGHT
•  A sponsor may transfer any or all trial related duties to a CRO, but the ultimate responsibility for the quality and integrity of the data resides with the sponsor
•  Guidance on the appropriate level of oversight
•  Create an oversight plan
•  Define quality goals and metrics
•  Write a co-monitoring plan and conduct co-monitoring visits