Three critical questions to ask when selecting a CRO

Q1: First, ask which functions should be done in-house or outsourced?
Base your answer on a careful analysis of what is value-adding for your company
If you're a small biotech, it it rarely value-adding to do e.g. Datamanagement in-house, establishing a validated DM-function. In contrast, establishing in-house statistical capabilities may add value, as it brings your company closer to your own data

Q2: What will be the key driver in the CRO selection that could affect Speed and Quality of the Trial?
Base your answer on a careful analysis of all relevant factors that could impact study start-up, conduct and completion, e.g. :
Protocol feasibility and site selection
Managing data quality (monitoring, electronic data capture, records)
Balancing sponsor resources vs. external resources

Q3: What will the study cost - what will it REALLY cost?
Identifying costs and developing realistic budgets is a difficult and timeconsuming exercise. When you get CRO cost-proposals, remember that even full-service CRO's may need to have subcontractors, e.g. medical imaging, lab, drug supply, etc - these additional costs need to be in the budget that YOU present to your Senior Management! You will not want to come back to ask for bigger budgets, because you did not get the full picture first time. Learn from former experience, but remember that clinical trials are always unique in some way or another.