An industry-wide drive to speed study start-up
Life science industry reports indicate that the early stages of study start-up take twice as long today as they did five years ago. The primary reason may be that, as trials have grown in complexity, so too have data collection activities related to site identification, feasibility ranking, and site selection, as well as the masses of paperwork related to IRB and ethics committee approvals.
Yet the processes used to gather, organize, and share all this information are largely unchanged. In a recent survey, fewer than a quarter of operations teams report using site portals—and more than 81% admit to still using spreadsheets to plot their start-up process.
No wonder that companies interested in modernizing their clinical operations frequently point to study start-up processes as a critical area for improvement.
Spreadsheets are a suboptimal study start-up solution for several reasons, including the amount of hands-on effort required. Such manual processes are not only time-consuming, but they are susceptible to human error, difficult to troubleshoot, and obstructive to regulatory compliance. Further, paper-based information exchange methods require multiple document handoffs between study partners, lacking immediacy that slows decision making.
It’s time for a change—and the industry seems ready.