Introduction
Biopharma organizations are under increasing pressure to effectively leverage an expanding
set of research, clinical, operational and real world data (RWD) to accelerate their trials and improve their chances of successfully launching new drugs. While data and advanced analytics hold great potential, accessing fit-for-purpose data sources, standardizing and integrating datasets, deriving actionable insights, scalability, and change management are major challenges along the way.
Poor operational outcomes have been a persistent and growing issue in the industry; 57% of trial protocols have at least one significant amendment that causes delays of more than three months, at a median direct cost of $500K each for a Phase III protocol. 90% of all trials are not able to enroll patients within target timeframes; each day a trial delays a drug’s time to market costs sponsors between $600K and $8M. These issues are further compounded by the impact of the COVID-19 pandemic on study starts, enrollment, and visits.