Digital Transformation of Clinical Trials

Clinical trials participants find themselves in the midst of a digitization-driven transformation to expedite drug delivery.  Technology providers fuel the objective to streamline clinical trials by developing innovative solutions that sites can deploy for patient recruitment, clinical outcome assessments, patient randomization, and even drug supply management.

On the flip side, these site-facing applications also introduce challenges, from integration to access.  With respect to the latter, investigators and other site personnel must possess unique logins and passwords per application.  In addition, each sponsor defines its own nomenclature and workflow requirements for application use.  As a result, sites bear an enormous burden that leads to frustration, confusion, questions over the value of technology adoption, and the possible introduction of security vulnerabilities.

To better capture the benefits of digitization and overcome its hurdles, TransCelerate, an organization comprised of more than 20 of the world’s largest pharmaceutical companies, developed the Shared Investigator Platform (SIP) with the help of Cognizant Technology Solutions and Exostar.  TransCelerate launched SIP in 2016 with a clear vision – create a unified platform that accepts a single trusted identity through which clinical trials participants access all eClinical applications.  By centralizing all study-specific needs, SIP increases efficiencies, reduces redundancies and administration at the clinical site, and improves application and data security.

The results on the ground prove the legitimacy of the vision.  With SIP available across the sites of sponsors including Amgen, Lilly, Merck, Pfizer, and Roche, more than 25,000 investigators rely on SIP today.  These individuals use a single credential, the Exostar Identity, to connect not only to SIP, but also to other applications in the Exostar ecosystem (such as site payment, document exchange, electronic data capture, central laboratory, and electronic trial master file solutions) to which they have been granted permission by the applications’ owners.  Over 250,000 individuals in the life science and healthcare industries belong to the Exostar community.

Looking ahead, with TransCelerate’s basic vision for SIP fulfilled, Cognizant plans to extend SIP availability beyond the TransCelerate member companies to the entire industry.  To encourage adoption, Cognizant intends to implement an open-API approach to ease SIP integration with evolving and emerging technology solutions and deliver a “single pane of glass” environment to all sponsors and their site partners.  At the same time, Exostar continues to enhance the value of the Exostar Identity for SIP and other users by extending its community and executing strategic alliances with the latest and leading technology providers.

These are exciting times.  Promoting the power of digitization and eliminating its burdens through SIP and the Exostar Identity harmonizes how the entire industry collaborates – accelerating the next pharmaceutical blockbuster to market to reduce pain and suffering and save lives.