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, E:, 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.”
We are drug safety experts. Our highly experienced teams focus in safety technology systems, adverse event management and medical affairs. Sentrx solutions (sentrx.com) include SaPh™, CROPlus™ and UniPhi™ and are customized, integrated and scalable to enhance efficiency, reduce cost, and improve flexibility. Our experience is unmatched, built over 15 years serving a broad range of bio-pharmaceutical clients, including CROs.
About TransPerfect Life Sciences Solutions
TransPerfect Life Sciences Solutions (trialinteractive.com) provides leading web-based platforms that enable sponsors, CROs, IRBs, central laboratories and other vendors to complete, maintain and update clinical trial documentation in a secure online collaborative environment, enabling fully searchable solutions including investigator portals and eTMFs. TransPerfect’s solutions streamline study timelines and reduce the administrative burdens of a clinical trial on a global basis. For more information on Trial Interactive or TransPerfect Life Sciences Solutions, please contact info[.]trialinteractive.com or +1 212.400.8848, or visit the website.
With revenue of over $250 million, TransPerfect (transperfect.com) is the largest privately held language services provider in the world. From offices in 66 cities on 5 continents, TransPerfect offers a full range of services in over 100 languages to multinationals worldwide. With a global network of over 4,000 linguists and subject-area specialists, TransPerfect is the largest translation company to be fully ISO 9001:2008 and EN 15038:2006 certified. TransPerfect is headquartered in New York and has regional headquarters in London and Hong Kong.
For information contact:
Michael Smyth - General Manager, Life Sciences Solutions TransPerfect
P: +1 212.689.5555 / E: msmyth[.]transperfect.com.