Pearl selects TransPerfect's Trial Interactive eTMF solution for clinical development programs

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."