Transperfect, Sentrx in Trial Safety Partnership

TransPerfect and Sentrx have entered a collaboration using TransPerfect’s Trial Interactive Portal Technology to develop a novel safety module that is fully validated and 21 CFR Part 11 compliant. The collaboration aims to streamline end-to-end global drug safety capabilities in both clinical and post-marketing event management. Trial Interactive is currently used for electronic Trial Master Files, investigator portals, IRB, and central lab solutions.   
 
The Trial Interactive Portal Solution is designed to provide safety information collection on a global basis from investigative site personnel via multiple sources, into a secure data portal. According to the companies, this approach will speed safety data exchange between safety teams and reporters while enhancing sponsors’ ability to support multiple stakeholders globally. The portal is compatible with Sentrx’s drug safety solution, SaPh, which provides Argus Safety instance management in a hosted deployment.
 
According to Michael O’Gorman, president and general manager of Sentrx, “Our collaboration with Trial Interactive has produced a fully compliant safety portal platform to enhance workflow efficiency. We believe this is a breakthrough approach our respective client base will find compelling under a wide variety of applications.”
 
Michael Smyth, general manager of TransPerfect’s Life Sciences Solutions division, said, “Working with Sentrx continues our vision of offering end-to-end technology and service solutions to all study stakeholders. The addition of the safety module in Trial Interactive, developed with Sentrx, provides the ability to truly offer global Pharmacovigilance support to pharmaceutical, biotechnology, and medical device companies as well as CROs.”