Assessing Outsourcing Oversight Practices and Performance

• Published in: Therapeutic innovation & regulatory science 2019-01, p.2168479018820880
• Main Authors: Wilkinson, Michael, Harper, Beth, Peacock, Julie, Morrison, Rick, Getz, Ken
• Format: Article
• Language: English
• ISSN: 2168-4804

The Tufts Center for the Study of Drug Development conducted a study updating benchmarks on outsourcing model adoption and assessing oversight practices and experience. An online survey examining organizational use of clinical development outsourcing was distributed between February and April 2018. Responses from a total of 88 individuals were included in the final analysis. More than half of individuals responding reported using 3 or more models simultaneously, mixing and matching approaches to meet individual project needs. Outsourcing practices among small, medium, and large sponsor companies remain inconsistent and deliver mixed levels of satisfaction and performance. Full-service models are the most commonly used. Biopharmaceutical companies report that the primary purpose of their oversight mechanisms is to minimize risks and regulatory missteps. Oversight mechanisms are generally supported by middle management personnel focusing on more reactive and tactical issues. Executive-level involvement in outsourcing oversight is minimal and highly variable. Several opportunities to improve oversight practices were identified in the study, including increasing executive-level involvement and leveraging technologies to monitor performance, enhance communication, and expand collaboration capabilities.