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