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, and 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. Pearl is rapidly advancing a pipeline of products including PT003, an inhaled, fixed-dose combination bronchodilator product comprised of a long-acting muscarinic antagonist (LAMA) and a long-acting beta-2 agonist (LABA) delivered via a metered dose inhaler (HFA MDI); and PT010, a triple-combination product that combines the LAMA and LABA components of PT003 with an inhaled corticosteroid (ICS) for twice-daily administration from an HFA MDI for the treatment of severe COPD. Both PT003 and PT010 are developed with Pearl’s proprietary porous particle cosuspension technology, which allows the formulation of multiple products in the MDI format, with highly stable, robust and aerodynamically efficient drug delivery. 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 TransPerfect Life Science Solutions
TransPerfect Life Science Solutions provides leading web-based platforms including eTMFs that enable sponsors, CROs, IRBs, central laboratories and other vendors to maintain and update clinical trial documentation in a secure online collaborative environment. The Trial Interactive platform enables fully searchable solutions including eTMFs and investigator portals. Trial Interactive solutions streamline study timelines and reduce the administrative burdens of global clinical trials. For more information on TransPerfect Life Science Solutions, please contact info@trialinteractive.com or +1 212.400.8848, or visit www.trialinteractive.com.
About TransPerfect
With annual revenues of over $250 million, TransPerfect is the largest privately held language services provider in the world. From more than 70 offices on 5 continents, TransPerfect offers a full range of services in over 100 languages to multinationals worldwide. With a global network of over 4,000 linguists and subject-area specialists, TransPerfect is the largest translation company to be fully ISO 9001:2008 and EN 15038:2006 certified. TransPerfect is headquartered in New York and has regional headquarters in London and Hong Kong. For more information, please visit our website at www.transperfect.com