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Monday, November 16, 2015 | 2:58 PM
Integration Allows Schulman to Streamline eTMF Filing and Compliance for Life Sciences Clients
NEW YORK, November 16, 2015 – TransPerfect, a leading provider of global development and commercialization solutions to the life sciences industry, today announced that Schulman IRB has integrated its IRB platform with the Trial Interactive electronic Trial Master File (eTMF) and study start-up solution to streamline global trial management for sponsors and CROs.
Trial Interactive is a web-based, 21 CFR Part 11 compliant platform that eliminates the redundancies inherent in paper-based study start-up and TMF management. By providing real-time access to clinical trial documentation as well as automated status notifications for protocols and investigative sites, the integration reduces the time and costs of manually managing IRB related documentation.
“Many of Schulman’s clients have moved to an eTMF environment and want an efficient way to have IRB related documentation directly into the eTMF with relevant metadata for auto-filing without human intervention. We chose to integrate with Trial Interactive as many of our mutual clients and potential clients are using the eTMF solution,” said Michael Woods, President and CEO of Schulman IRB. “With its automation and global document management capabilities, Trial Interactive helps our customers streamline processes while meeting regulatory requirements, allowing for remote inspections and even faster start-up timelines.”
Michael Smyth, General Manager of TransPerfect Life Sciences Solutions, stated, “We have daily interaction with our eTMF and study start-up clients who use or are planning to use Schulman IRB as their central IRB. Clients were spending an inordinate amount of time downloading IRB related documents, uploading them to our eTMF, and coding metadata. We’ve now automated that process to take place without user involvement and eliminated the need for users to look at multiple systems, which has always been a challenge for study teams. This integration will also extend to our electronic Investigative Site File (eISF) to streamline administrative work for sites.”
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.