Article | March 23, 2022

More Than Document Collection: The eTMF As The Conductor Of Study Start-Up Part 1 – Site ID And Selection

Source: TransPerfect
Rev Guidelines For Selecting A Medical Device Contract Manufacturer

Study start-up (SSU) is all about speed, because in the costly world of clinical trials, time is literally money. A recent study places the cost of the median Phase III clinical trial at nineteen million dollars[1], and a typical Phase III trial may take between one and four years to complete. A study conducted by the Tufts Center for the Study of Drug Development found that start-up for an individual site (pre-visit to site initiation) takes about eight months, a significant portion of the overall time and expense of a clinical trial[2].  Clinical trial delays can cost a sponsor between six hundred thousand and eight million dollars per day[3], but despite the high stakes and costs, 11% of selected sites are not activated[4], and in a given trial, 30 to 70% of sites will fail to deliver a single enrolled patient[5].

What SSU needs is a conductor, and the eTMF is capable of filling this role. In this blog series we’ll examine some key events of SSU, and show how an eTMF, when used to its full potential, can play a central role in mitigating the drivers of delay by helping the many stakeholders of a clinical trial work together. In this post, we’ll discuss how the eTMF can mitigate the main drivers of delay in the site ID and Selection process.

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