Great leaders are laser-focused on what truly matters. They show a great sense of judgment and discernment. How do leaders react to obstacles that are thrown at them on a regular basis? What type of concerns will keep them up at night? How do they mitigate risks and find the peace of mind that allows them to align their staff under a single vision?
Comprehend surveyed over 300 Clinical Operations leaders from the world’s largest and highest growth life sciences companies. This survey uncovered strong consensus from ClinOps leaders on their goals and challenges. The survey highlighted a number of processes and issues that prevent life sciences clinical operations teams from achieving their risk, productivity and cost reduction goals.
The roadmap forward includes an innovative approach called Continuous Quality that is enabling leading life sciences companies to deliver speed to quality results.
Funding Initiatives to Reduce Uncertainty and Improve Milestone Achievement
Clinical Operations is all about making important decisions on short and long-term resource allocation to safely deliver a high quality study, on-time. How successful did our respondents think they are? 80 percent are reporting that they regularly miss milestones and only 10 percent deliver their results on time. All 300+ respondents highlighted that they are funding initiatives to eliminate uncertainty and improve milestone achievement.
The ClinOps leaders mentioned equal emphasis on initiatives such as Centralized and Risk Monitoring, Study Quality Metrics, CRO Oversight & Collaboration, as well as Continuous Quality. Their plan to eliminate study uncertainty is investing to gain real-time, quality insight to questions such as “Where are we in the project?” through to “What needs to be done in order to get back on track?”
Spreadsheets and Single System Reporting No Longer Sufficient to Run the Studies
ClinOps leaders are relying on data from a wide variety of systems including EDC, CTMS, IRT, Lab and Safety. In order to make critical business decisions from these disparate systems, 65 percent responded that their primary Clinical Operations decision support system is a spreadsheet. While most reported out on key metrics monthly, some are using spreadsheets to report out weekly and daily. Only 8 percent have automated the initiatives to gain the critical insights they need to lower risk and increase speed.
Enrollment, Site Productivity, and Subject Compliance Execution Challenges are Costly
Ninety-five percent of the ClinOps leaders identified enrollment as the most important trial execution focus area to meet study milestones. 53 percent indicated that they are “not very successful” at managing enrollment. Similarly for both Site Productivity and Subject Compliance, over 75 percent reported that they are “not very successful.”
Continuous Quality Eliminates Uncertainty Across the Portfolio of Clinical Trials
ClinOps teams are now monitoring their portfolios and making critical decisions in real-time.
They are leveraging a single system with powerful data aggregation, monitoring, collaboration and analytic capabilities to actively manage enrollment funnels, protocol compliance, data quality and site productivity across systems, studies, and sites. With Continuous Quality, ClinOps Executives, Study Managers, CRAs and their CROs are now focusing on what matters and acting faster.
The net result: reduction in study overruns, achievement of on-time milestones, while returning sites to within risk threshold.
Filed Under: Drug Discovery