Three of the greatest fears that a Sponsor experiences when initiating a new trial are: “What if the study does not enroll according to corporate timelines?”, “What if the study runs over budget?”, and “What if the data quality is subpar?” Each of these “what ifs” can have a significant cost implication for the Sponsor company, since a delay in timeline carries with it a delay in revenue actualization.
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.
Attachments: Determining if You Need a Study Rescue.