Solution Enables Regado Biosciences to Streamline 500-Site Global Study
TransPerfect, a leading provider of e-clinical solutions to the life sciences industry, recently announced that Regado Biosciences has implemented TransPerfect’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 (REGULATEPCI). 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 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 Trial Interactive
TransPerfect’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 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 eTMF review/reconciliation, pharmacovigilance and safety management, endpoint adjudication, and product licensing and alliance management. For more information, www.trialinteractive.com.
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. For more information, visit www.regadobio.com.