Jun 21 2011
TransPerfect and Sentrx have announced a collaboration involving TransPerfect's Trial Interactive Portal Technology, which will streamline end-to-end global drug safety capabilities in both clinical and post-marketing event management. Trial Interactive, already widely used throughout the biopharmaceutical industry for electronic Trial Master Files, investigator portals, IRB, and central laboratory solutions, collaborated with Sentrx to develop a novel safety module that is fully validated to be 21 CFR Part 11 compliant.
The Trial Interactive Portal Solution will enable direct safety information collection on a global basis from investigative site personnel via multiple sources, including fax, email, direct-entry, or by telephonic means, into a secure data portal. The approach will speed safety data exchange between safety teams and reporters while enhancing sponsors' ability to support multiple stakeholders globally. The portal is fully compatible with Sentrx's industry leading drug safety solution, SaPh™ which provides turnkey Argus Safety instance management in a hassle-free, hosted deployment.
According to Michael O'Gorman, President and General Manager of Sentrx, "Web based portal solutions have been identified as a critical imperative for achieving new gains in adverse event management efficiency. 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 commented, "Working with Sentrx continues with our vision of offering end-to-end technology and service solutions to all study stakeholders, particularly investigative site personnel who are critical in the process of getting products to market faster. 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."