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Friday, June 17, 2011 | 5:01 PM
Trial Interactive eTMF enhanced with co-developed safety module enables advanced adverse event management
New York, NY and Little Falls, NJ, June 17, 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.”
We are drug safety experts. Our highly experienced teams focus in safety technology systems, adverse event management and medical affairs. Sentrx solutions 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. To learn more about Sentrx, please visit www.sentrx.com.
About Trial Interactive
TransPerfect’s Trial Interactive solution provides a collaborative, web-based platform for clinical development that enables sponsors, CROs, IRBs, and other vendors to maintain and update clinical trial documentation in a secure online environment, adhering to global regulatory requirements. With fully searchable solutions including investigator portals, Trial Interactive streamlines study timelines and reduces the administrative burdens of global clinical trials. As part of TransPerfect’s Life Sciences division, Trial Interactive is dedicated to working with clients on a global, collaborative level, supporting a wide range of requirements including e-feasibility, study start-up, eTMF review/reconciliation, mobile applications, learning management and document management systems, investigator portals, pharmacovigilance and safety management, and endpoint adjudication. For more information on Trial Interactive, please contact email@example.com or +1 212.400.8848, or visit www.trialinteractive.com.
TransPerfect is the world’s largest provider of language services and technology solutions for global business. From offices in over 90 cities on six continents, TransPerfect offers a full range of services in 170+ languages to clients worldwide. More than 4,000 global organizations employ TransPerfect’s GlobalLink® Product Suite to simplify management of multilingual content. With an unparalleled commitment to quality and client service, TransPerfect is fully ISO 9001 and ISO 17100 certified. TransPerfect has global headquarters in New York, with regional headquarters in London and Hong Kong. For more information, please visit our website at www.transperfect.com.