The clinical trials sector has done a good job tracking costs associated with study execution, but costs linked to study startup are conspicuously absent. A quick look at industry research confirms this gaping hole in cost accountability.
If you fail to plan, you are planning to fail. Proactive planning requires sponsors and CROs to identify the risks up front, as well as the study requirements, prior to study activation. Failure to do so results in problems not being identified until much later, often in advance of an inspection and well after completed documents have been released to the trial master file.
With so much at stake where do you start when considering the right long-term strategic CRO partner? With technology and the market both priming CROs to step in as industry innovators, what attributes should sponsors look for in ‘best-in-class’ strategic partners?
Research indicates principal investigators spend 42% of their time on “administrative burden”, with IRB-related burdens ranking the highest, with a third of the time required for IRB approval due to researcher omissions and errors. Addressing the inefficiencies in IRB approvals is essential to reducing costs and speeding the delivery of life saving therapies to patients in need. How can a streamlined system improve and expedite human research oversight?
For years, this laborious step has ranked as the lengthiest of study startup activities, and recent data suggests it remains the primary cause of site activation failure. With the pharmaceutical industry’s intense focus on better performance, stakeholders are ready to embrace strategies that identify and help shorten long contract cycle times.