Comprehend recently released a survey of over 100 Clinical Operations leaders from some of the most innovative, high-growth and demanding life sciences companies. The survey provides clear consensus on their goals, challenges and best practices for CRO oversight. It provides program, study and vendor oversight teams insights into how their peers are approaching this initiative. The biggest takeaway? Clinical Intelligence provides the CRO oversight and collaboration needed to deliver speed to quality results.
The CRO Oversight Benchmark survey include detailed responses in four key areas: goals, execution, best practice, and the roadmap forward. It was evident that most sponsors were aligned on goals and challenges as 98% of those surveyed have CRO oversight as a top priority yet 66% mentioned they are not successful in achieving their planned CRO goals. The clinical leaders indicated their top CRO oversight program goals include, in order of priority, first to avoid trial delays, second to meet compliance requirements (e.g., E6 R2), and third to manage quality and cost reduction. All respondents indicated they had some level of investment in CRO oversight but that there were challenges in execution with 64% stating that their decision making is “reactive”.
The survey demonstrated alignment on best practices with the focus on Quality Agreements and Oversight Plans. In fact, 78% mentioned that CRO oversight plans are of the highest importance to company. Also agreed upon were three key focus best practice areas for the Quality Agreement KPIs: subject enrollment funnel; priority subject compliance with measures for protocol deviations, adverse events and subject visit compliance; and site productivity metrics. Respondents indicated that top priority for executives is a portfolio view to allow for analysis across studies, systems and CROs.
With 100% of those surveyed anticipating process changes due to the pending ICH E6 (R2) guidelines it is no wonder that a solution to automate their quality agreements and oversight plans is top of mind. Sponsors agreed on several key requirements for CRO Oversight automation: data transparency (71%), real time insights (69%), integrated collaboration tools (67%), visibility across systems, studies and CROs (60%) and a full audit trail (43%). Sponsors are choosing Clinical Intelligence to meet these requirements. Clinical Intelligence provides transparency on data and operational systems, collaboration, and real time monitoring. A recent case study shows Clinical Intelligence reduced cycle time overruns by 46%, moved the study and sites to within risk threshold, and avoided over $420K in change orders.