ABSTRACT
Simultaneously, advances in mobile technology, data aggregation and analysis tools, and risk management methodologies are changing how clinical trial data are collected and monitored, influencing how companies outsource core clinical research tasks. The established full-service model, in which biopharmaceutical companies retain a preferred contract research organization (CRO) to perform the full range of clinical trial activities, has been increasingly complemented by an functional service provider (FSP) approach, which allows companies to engage discrete expert services- such as medical writing, biostatistics, or clinical monitoring-when and where they need them. [...]it cultivates continuity because FSP relationships tend to be long-term. [...]companies that need to bolster a specific type of expertise or fill a geographic gap are using FSP to do so in a highly targeted fashion. [...]data aggregation, AI, and machine learning were steadily gaining traction pre-pandemic. Because the value of a CRA rises rapidly with experience and a solid track record-and they move up quickly-we are facing a potential shortage of Level 1 or entry-level CRAs. [...]Parexel enhanced its recruitment and training efforts in parts of the world where supply and demand for CRAs is not as tight.