By Craig Morgan NZCS, MBA (Hons), PMP, goBalto, Inc.
Investigative sites are the heart and soul of the life sciences sector as they perform the all-important clinical trials. This is a massive undertaking, as clinical trials are a complex, multi-step process starting with first-in-human studies, moving through to pivotal trials for regulatory submission, and ending with post-marketing initiatives. One of the most difficult aspects is the selection of the right sites by sponsors and contract research organizations (CROs), who often lack a transparent, evidence-based strategy for this task. Instead, they frequently rely on archaic paper-based or spreadsheet methods to identify sites across the globe with a reasonable chance of enrolling the contracted number of patients on schedule, and the ability to generate quality data. Using this approach, site selection, a critical step in study startup (SSU), has long been an intense challenge with limited success. More recently, however, purpose-built technologies have emerged to address this problem, using data from multiple sources and algorithms to direct sponsors and CROs to the right sites, increasing their chances for better study execution.