TransCelerate BioPharma, a nonprofit run by 19 of the world's largest drugmakers, formed two years ago to help Big Pharma share resources and stop wasting time and money on noncompetitive work. Now, the group is looking to create a novel platform to standardize how clinical trial sites communicate with sponsors, choosing contractor Cognizant ($CTSH) to develop it.
As it stands, the means by which investigators report to drugmakers are usually company-specific, creating an inefficient system that requires clinical trial sites to master multiple platforms and increasing the chance of error. Cognizant is charged with developing what TransCelerate calls a Shared Investigator Platform, envisioned as an industry utility that would standardize the process, providing a single access point for all parties.
The group believes such a system can boost accuracy, reduce study start-up time and help pharma companies improve the quality of their data. Down the line, the new system could also provide regulators with a seamless process for auditing trials, TransCelerate said.
"This collaboration is an important part of TransCelerate's strategy to improve clinical trial processes in order to bring innovative new medicines to patients faster," Jackie Kent, an Eli Lilly ($LLY) executive leading the Shared Investigator Platform effort, said in a statement. "... TransCelerate conducted a comprehensive selection process for this initiative, and Cognizant provided the key attributes required for this unique partnership."
TransCelerate's latest move follows a May partnership with Medidata ($MDSO), which signed on to share its expertise in risk-based management with the group. The idea behind the Medidata collaboration is to amass analytical evidence to support adaptive clinical trials, advocating for more in the industry to adopt the associated technology.
The deals address two of TransCelerate's 5 founding goals, leaving mutual recognition of study site qualification, development of clinical data standards and establishment of a comparator drug supply model.
The group's membership includes AstraZeneca ($AZN), Boehringer Ingelheim, Bristol-Myers Squibb ($BMY), GlaxoSmithKline ($GSK), Johnson & Johnson ($JNJ) and Pfizer ($PFE), among others.
- read the statement