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Monday, October 21, 2013 | 4:22 PM
Solution Enables Regado Biosciences to Streamline 500-Site Global Study
NEW YORK, October 21, 2013 – TransPerfect, a leading provider of e-clinical solutions to the life sciences industry, today announced that Regado Biosciences has implemented TransPerfect's Trial Interactive solution to streamline study start-up and electronic master file (eTMF) management for its ongoing 500-site Phase III global study (REGULATE-PCI). Trial Interactive is a web-based, 21 CFR Part 11 compliant platform that eliminates the redundancies inherent in paper-based management of clinical trials.
"We were looking for a way to conduct our 500-site global trial more efficiently," said Raul P. Lima, Executive Director of Clinical Operations at Regado Biosciences. "Trial Interactive's Study Start-Up and eTMF solution enhances transparency for both Regado and its partners, and allows us to run the study with as little paper as possible."
TransPerfect's Study Start-Up module is an end-to-end e-clinical tool designed to manage the global site activation process. All activities and documents related to initiating a site - from regulatory package distribution through regulatory approval - are tracked and managed with the module. By providing stakeholders with real-time access to clinical trial documentation, Trial Interactive eliminates travel and shipping costs associated with review and reconciliation, thereby streamlining clinical development programs.
Michael Smyth, General Manager of TransPerfect's Life Sciences Solutions, said "Our goal is to provide a user-friendly platform through which sponsors and CROs can conduct paperless global trials. We look forward to supporting Regado's REGULATE-PCI study."
About Regado Biosciences
Regado Biosciences, Inc. is a biopharmaceutical company focused on the development of novel, first-in-class, actively controllable antithrombotic drug systems for acute and sub-acute cardiovascular indications. Regado is pioneering the development of two-component drug systems consisting of a therapeutic aptamer and its specific active control agent. The company’s lead product candidate, REG1, is a two-component system consisting of pegnivacogin, an anticoagulant aptamer specifically targeting coagulation Factor IXa, and its complementary oligonucleotide active control agent, anivamersen. REG1 is being developed for use in patients with a wide variety of acute coronary syndromes, or ACS, undergoing a percutaneous coronary intervention, or PCI, a hospital-based procedure used to mechanically open or widen obstructed coronary arteries. Regado’s actively controllable product candidates have the potential to improve patient outcomes, enhance the patient experience and reduce overall treatment costs. More information can be found at www.regadobio.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 firstname.lastname@example.org 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.