Eichler, Gabriel, Imbert, Georges, Branson, Janice, Balibey, Rene, Laramie, Jason, Hersch, Greg, Askin, Scott, Kauffmann, Audrey, Speyer, Peter, Cochrane, Andrew, Mannan, Haripriya, Rudolph, Amy, Asakiewicz, Christopher, McGovern, Patricia, Ramanathan, Krishnan and Ballard, Mary (2022) Democratizing data at Novartis through clinical trial data access. Drug discovery today. ISSN 1878-5832

Abstract

Enabling broad access and usage of clinical trial data within biopharmaceutical companies has historically been impeded by technical, cultural, and policy hurdles. Novartis has attempted to address this comprehensively through a program called data42; here, we explore how a diverse set of enterprise-wide stakeholders formulated a risk-based data access approach to streamline access to anonymized clinical trial data and vastly improved its use by authorized research and development (R&D) associates within the company. The result is that most Novartis clinical trial data requests, from internal associates, can now be automatically approved. The process of developing this framework and its impact on Novartis and the broader industry are explored and discussed.

Item Type:	Article
Date Deposited:	08 May 2022 00:45
Last Modified:	08 May 2022 00:45
URI:	https://oak.novartis.com/id/eprint/45720