Gaps in performance and quality data, plus a lack of process, have made it difficult to inform decisions and improve outcomes for study start-up. Today, advances in analytic capabilities provide insights that simply did not exist before. A new approach to solving start-up delays is built on this foundation of advanced data analytics and accelerates study start-up timelines by 33 percent.
Research sites are critically important to the development and testing of new therapies. They help bring new treatments to patients — and provide the reliable data that stops the development of unsuccessful projects. While active, organized sites are essential to support the conduct of clinical trials, many clinicians who explore participating in clinical research never proceed beyond a first trial. This paper discusses what high-performing research sites have in common, and what makes sponsors return to them again and again.
Nearly 80 percent of clinical trials fail to meet their activation timelines. But why does the start-up process fail us this often? This question can be answered by implementing a feasibility maturity model with six critical variables: data, process, technology, expertise, focus, and engagement.
Well-performed site feasibility can become the single most important factor in reducing costs and time spent in a clinical trial. With adoption of benchmarking and clinical trial tools, sponsors are able to know exactly how many sites they need in their trial, which makes site pre-identification essential for efficient study start-up.
In a clinical trial so much depends on contract execution and budget development; when they are not appropriately managed, progress across other study start-up areas comes to a halt. Valuable time is wasted, which costs dearly. By implementing three successful approaches to a new way of conducting contracting and budgeting, sponsors and CROs can see a 37 percent faster site contract execution timeline.