A large number of clinical trials are outsourced to Contract Research Organizations (CROs) each year. While the majority of these trials are successfully implemented and study results are delivered on-time and on-budget, situations arise when the study is not adequately managed by the vendor and the study must be “rescued”. The scope and type of study management deficiency needs to be assessed by the Sponsor to determine the type of remediation required. Rescue support may be as simple as adding third-party function experts to the Sponsor project team to aid in the management and oversight of the CRO, or as complex as selecting a new CRO to assume all responsibility for the study.
Data Management Rescues Whitepaper