Unlike industry-sponsored trials focused on regulatory approval of new medications, Investigator Sponsored Trials (ISTs) are developed and executed under the direction of third-party clinical investigators who are physician researchers, often within an academic institution. The investigator or affiliated study sponsor, working in an academic medical centre, is responsible for study conception, design, operational execution, data handling, and data analysis and interpretation, along with subsequent publication. Source: www.centerwatch.com/ articles/15646
ISTs are a beneficial method to better understand the potential risks, safety and additional uses that can improve patient health. Participating in ISTs, from a biopharma point of view, however, does present challenges with supply chain management. This white paper addresses the common challenges faced by biopharma organizations with regards to supply chain management and offers insight into solutions by leveraging the RTSM/IRT.