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Wednesday, April 6, 2016 | 2:55 PM
eClinical Solution Enables Karyopharm to Move to a Paperless Global Trial Process
NEW YORK, NY, April 6, 2016 – TransPerfect, a leading provider of global development and commercialization solutions to the life sciences industry, today announced that Karyopharm Therapeutics has implemented Trial Interactive as its electronic Trial Master File (eTMF).
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 study stakeholders with real-time access to clinical trial documentation, Trial Interactive cuts out the travel and shipping costs associated with paper review and reconciliation, consolidating clinical trial documentation processes for Karyopharm. With modules for e-feasibility, study start-up, eTMF, document management, and learning management systems, Trial Interactive offers Karyopharm an end-to-end e-clinical solution to streamline their processes and increase inspection readiness for their TMFs.
“We looked at many eTMF systems, but felt Trial Interactive was the most robust for Karyopharm’s global use,” stated Tracey Marshall, Senior Director, Clinical Operations at Karyopharm. “It provides real-time access for our global teams and transparency into the status of the TMF for all of our studies. Plus, we have access to Trial Interactive’s other integrated modules as we evolve our process. ”
Liz Elting, Co-CEO of TransPerfect, stated, “We are honored to be selected as the eTMF provider by Karyopharm. Since we built the Trial Interactive platform over six years ago, our goal has always been to enable us to assist companies with paperless initiatives just like these in order to maximize efficiency in conducting studies and expedite time to market for our clients and their products.”
“Karyopharm is taking a very important step in keeping with the trends and best practices in clinical research,” added TransPerfect Co-CEO Phil Shawe. “We have invested massively in R&D related to our web-based eTMF solutions, and the Karyopharm engagement is a true validation of the value that our technology platform provides. We appreciate the opportunity to partner with Karyopharm.”
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.