Guest Column | July 9, 2015

The Need For Speed In Clinical Study Startup


By Craig Morgan, brand development director at goBalto Inc.

The status of clinical trials continues to stymie industry stakeholders anxious to rein in the cost of product development and adhere to tighter timelines. Despite intense pressure to speed development, mounting evidence documents ongoing inefficiencies tied to complicated protocols, globalization, and old-school paper-based processes, driving clinical stakeholders to embrace technologies that are finally moving the needle.  Cloud-based solutions such as clinical trial management systems (CTMS), electronic data capture (EDC), and the electronic trial master file (eTMF) are all quantum leaps, but their adoption rates vary. And significantly, they do not address one of the most inefficient and costly bottlenecks of clinical trial conduct – study startup (SSU). A study conducted by the Tufts Center for the Study of Drug Development (CSDD) determined that it takes eight months, on average, to move from pre-visit through site initiation.[1] The cost of initiating a site has been estimated at $20,000 to $30,000[2], followed by the cost of maintaining a site, which is approximated at $1,500 per month.[3]