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Monday, August 22, 2011 | 4:59 PM
Pearl Therapeutics Selects TransPerfect's Trial Interactive As Its Electronic Trial Master File (eTMF) Enterprise Solution
The Trial Interactive eTMF Platform Allows Pearl to Streamline and Accelerate its Global Study Conduct
NEW YORK, August 22, 2011 – TransPerfect today announced that Pearl Therapeutics has implemented TransPerfect’s Trial Interactive electronic Trial Master File (eTMF) solution for the company’s clinical development programs. Trial Interactive is a secure web-based platform that eliminates the redundancies inherent in paper-based TMF studies. Trial Interactive complies with FDA’s 21 CFR Part 11 regulation which outlines the requirements for maintenance of electronic records.
“After looking at a number of eTMF providers, we selected TransPerfect’s Trial Interactive solution because of its ease of use, robust functionality, client services support,” said Chad Orevillo, Vice President and Head of Clinical Operations at Pearl. “We were looking for a solution that solved our current challenges with paper TMFs and was scalable to meet our future needs as they evolve. Trial Interactive provides that capability, and is also backed by TransPerfect’s extensive experience in global clinical trials.”
Trial Interactive gives Pearl the ability to move towards a paperless TMF environment, providing real-time access to study stakeholders on a global basis. Giving investigative site staff access to Investigator Site Files can further streamline study conduct while eliminating many of the costs associated with shipping documents to sites throughout the world.
Pending the results of the Phase II program, Pearl Therapeutics plans to embark on a global Phase III program, which will require extensive global collaboration with investigative sites. By utilizing the translation request module integrated into the Trial Interactive eTMF as well as an interface translated into over 20 languages, study conduct could be further streamlined around the world.
Michael Smyth, General Manager of TransPerfect’s Life Science Solutions division commented, “As a leader in the search for treatments of severe respiratory illnesses, Pearl Therapeutics requires the fastest and most efficient clinical trial processes to rapidly execute its clinical development program. Through Trial Interactive, Pearl Therapeutics can execute its clinical development more efficiently, with a streamlined, paperless, and global eTMF solution.”
About Pearl Therapeutics
Pearl Therapeutics is a privately held company developing combination therapies for the treatment of highly prevalent respiratory diseases, including chronic obstructive pulmonary disease and asthma. Founded in 2006, Pearl Therapeutics is privately held and backed by 5AM Ventures, Clarus Ventures, New Leaf Ventures and Vatera Healthcare. For more information, please visit www.pearltherapeutics.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.