Screening Prospective CROs: What Are Their Data Capabilities?

Clinical development is the most costly aspect of getting a drug, medical device or diagnostic to market.  Previously priced at $1.3 billion, getting a product approved is now estimated to cost as much as $5 billion. If you entrust management of your clinical trial to a CRO, what criteria should you look for in a partner to ensure the most reliable results with the greatest efficiencies at the most affordable price?

One major issue for sponsors partnering with CROs for analytic services is the ability to directly access and retrieve their raw data, which may only be accessible from the CRO's data warehouse, source systems, or down-stream analysis platforms.  Requesting and receiving both ad-hoc/custom and periodic standard reports from their CRO can potentially result in critical time lags and inefficiency for program, country, study and data managers, as well as for clinical research associates, investigators, clinicians and safety officers.