E-Clinical Solution Enables CTI to Move to a Paperless Global Trial Management Process
NEW YORK--(BUSINESS WIRE)--TransPerfect, a leading provider of global development and commercialization solutions to the life sciences industry, today announced that CTI Clinical Trial and Consulting Services (CTI) has implemented Trial Interactive as its electronic Trial Master File (eTMF) and study start-up solution to streamline global trial management for its development programs.
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 CTI and its sponsors. With modules for study start-up and eTMF, Trial Interactive offers CTI an end-to-end e-clinical solution.
"At CTI approximately 80% of our studies meet or exceed enrollment expectations, despite the challenging patient populations we work in, which is due in part to our excellent pre-trial and start-up processes," stated Kevin Schwarz, Chief Operating Officer, CTI. "With its automation and global document management capabilities, Trial Interactive helps us streamline our study management process while meeting regulatory requirements, allowing for remote inspections and even faster start-up timelines."
"We chose the Trial Interactive platform because it is a true paperless application that delivers the innovation and anytime/anywhere accessibility we need in order to serve our nearly one hundred clients in the pharmaceutical and biotechnology industry," added Louis Minham, Senior Director, Information Technology, CTI.
Michael Smyth, General Manager of TransPerfect Life Sciences Solutions, stated, "We are excited to have been chosen as a strategic partner of CTI to help them move towards a virtual clinical development program that will meet regulatory requirements. We appreciate that they see the value of the solution, not only for CTI and their sponsors, but for investigative site personnel who will benefit greatly from the added efficiencies it offers."
About TransPerfect Trial Interactive
TransPerfect'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 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, eTMF review/reconciliation, pharmacovigilance and safety management, endpoint adjudication, and product licensing and alliance management. For more information on Trial Interactive, please contact [email protected] or +1 212.400.8848, or visit www.trialinteractive.com.
About CTI Clinical Trial and Consulting Services
CTI Clinical Trial and Consulting Services is an innovative, international drug and device development organization that delivers a full spectrum of clinical trial and consulting services from bench to commercialization with a focus on immunology and a passion for helping life-changing therapies succeed in chronically and critically ill patient populations. CTI's focused therapeutic approach provides pharmaceutical, biotechnology and startup firms with clinical and disease area expertise from a unique mix of academic, medical and industry specialists; rich intellectual capital in transplantation, immunology, infectious diseases, hematology, cardiology, nephrology, hepatology, regenerative medicine and rare diseases; flexible study designs that accelerate development programs and deliver high approval ratings that are among the best in the industry; and exceptional global project management and gold standard safety and data management systems that strengthen their program's success potential. Established in 1999 and headquartered in Cincinnati, OH; CTI has offices in North America, Europe, Latin America and Pac-Asia. For additional information, please visit www.ctifacts.com.