NEW YORK, June 16, 2014 – TransPerfect, a leading provider of e-clinical solutions and language services to the life sciences industry, today announced that Cubist has selected Trial Interactive as their electronic Trial Master File (eTMF) enterprise solution across several clinical programs. Trial Interactive is a web-based, 21 CFR Part 11 compliant platform that integrates clinical documentation and trial development.
TransPerfect’s Life Sciences Solutions division is committed to the e-clinical space; eTMF is just one of many Trial Interactive modules designed to support global clinical development. In addition to eTMF, Trial Interactive offers solutions for site feasibility, study start-up, endpoint adjudication, pharmacovigilance, safety reporting, and more to provide a paperless clinical development platform.
Trial Interactive provides real-time accessibility to study stakeholders on a global basis, advancing offerings in clinical development by facilitating efficient management of the TMF. Trial Interactive’s globally accessible platform will allow clients to meet both regulatory requirements and security needs worldwide.
“Trial Interactive will significantly improve efficiencies in managing final documentation through storing all final Trial Master File (TMF) documents electronically in a secure and regulatory-compliant manner,” explained Michael Smyth, General Manager of TransPerfect’s Life Sciences Solutions. “We’re proud to support Cubist in executing clinical development more efficiently, with a streamlined, paperless, and global eTMF solution.”
About Cubist
Cubist Pharmaceuticals, Inc. is a global biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address significant unmet medical needs in the acute care environment. Cubist is headquartered in Lexington, Massachusetts, with a central international office located in Zurich, Switzerland. Additional information can be found at Cubist’s web site at www.cubist.com.
About Trial Interactive
TransPerfect’s Trial Interactive solution provides a collaborative web-based 21 CFR Part 11 compliant platform for study start-up and eTMF that enables sponsors, CROs, IRBs, central laboratories, and other vendors to maintain and update clinical trial documentation in a secure, online environment. With fully searchable solutions including investigator portals, Trial Interactive streamlines study timelines and reduces the administrative burdens of global clinical trials. As a part of TransPerfect’s Life Sciences Solutions division, Trial Interactive is dedicated to working with clients on a global, collaborative level, supporting a wide range of requirements including eTMF review/reconciliation, pharmacovigilance and safety management, eFeasibility, endpoint adjudication, and product licensing and alliance management. For more information on Trial Interactive, please contact info@trialinteractive.com or +1 212.400.8848, or visit www.trialinteractive.com.
About TransPerfect
With annual revenues of over $400 million, TransPerfect is the world’s largest privately held provider of language services and technology solutions. From offices in 85 cities on six continents, TransPerfect offers a full range of services in 170+ languages to clients worldwide. With an unparalleled commitment to quality and client service, TransPerfect is fully ISO 9001 and EN 15038 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.