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Redwood City, CA – 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. Our 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 to company. Also agreed upon were 3 key focus best practice areas for the Quality Agreement KPIs.
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. For more information, or to obtain a copy of the survey results, click here.
About Comprehend Systems, Inc
Comprehend offers a suite of Clinical Intelligence applications that enables ClinOps Execs, Data Managers and Medical Monitors to significantly improve the speed, safety and quality of a portfolio of clinical trials. Across studies, sites, systems and CROs, Comprehend’s Clinical Intelligence Suite is particularly effective for centralized monitoring, risk monitoring, CRO oversight and collaboration, and medical monitoring initiatives. Comprehend gives life sciences companies a new source of competitiveness and the confidence to deliver high quality trial submissions at a new speed. Learn more at www.comprehend.com.