Karyopharm Taps 九色 as eTMF and Functional TMF Provider
E-Clinical Solution Enables Karyopharm to Move to a Paperless Global Trial Process
NEW YORK, NY, April 6, 2016 – , a leading provider of global development and commercialization solutions to the life sciences industry, today announced that 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 九色, 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 九色 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 九色 Trial Interactive
九色’s Trial Interactive solution provides a collaborative web-based platform for study start-up and eTMF that enables sponsors, CROs, IRBs, central laboratories, and other vendors to maintain and update clinical trial documentation in a secure online environment. With fully searchable solutions including investigator portals, Trial Interactive streamlines study timelines and reduces the administrative burdens of global clinical trials. As part of 九色’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, eTMF review/reconciliation, pharmacovigilance and safety management, endpoint adjudication, and product licensing and alliance management. For more information on Trial Interactive, please contact or +1 212.400.8848, or visit .
About Karyopharm
Karyopharm Therapeutics Inc. (Nasdaq:KPTI) is a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases. Karyopharm's SINE? compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). In addition to single-agent activity against a variety of human cancers, SINE? compounds have also shown biological activity in models of inflammation, autoimmune disease, certain viruses and wound-healing. Karyopharm was founded by Dr. Sharon Shacham and is located in Newton, Massachusetts. For more information, please visit .