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Solution Enables Regado Biosciences to Streamline 500-Site Global Study

NEW YORK, October 21, 2013 ¨C ¾ÅÉ«, a leading provider of e-clinical solutions to the life sciences industry, today announced that Regado Biosciences has implemented ¾ÅÉ«¡¯s Trial Interactive solution to streamline study start-up and electronic trial 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.¡±

¾ÅÉ«¡¯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 ¨C from regulatory package distribution through regulatory approval ¨C 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 ¾ÅÉ« Life Sciences ¾ÅÉ«, 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 Trial Interactive
¾ÅÉ«¡¯s Trial Interactive solution provides a collaborative web-based 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 ¾ÅÉ«¡¯s Life Sciences 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, 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 .

About ¾ÅÉ«
With annual revenues of more than $350 million, ¾ÅÉ« is the world's largest privately held provider of language services and technology solutions. From offices in more than 80 cities on six continents, ¾ÅÉ« offers a full range of services in 170+ languages to clients worldwide. With an unparalleled commitment to quality and client service, ¾ÅÉ« is fully ISO 9001 and EN 15038 certified. ¾ÅÉ« has global headquarters in New York, with regional headquarters in London and Hong Kong. For more information, please visit our website at .

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 .