E-Clinical Solution Enables Migration to a Paperless Global Trial Process
TransPerfect Life Sciences, a leading provider of global development and commercialization solutions to the life sciences industry, recently announced that Agility Clinical has implemented Trial Interactive as its electronic Trial Master File (eTMF).
Agility Clinical is a California-based consulting and contract research organization (CRO) who specializes in assisting pre-clinical and clinical stage companies with complex trials and studies involving rare diseases.
Trial Interactive is an e-clinical platform used by leading biotechs, pharmas, and CROs in the product development process. As a web-based, 21 CFR Part 11-compliant platform, Trial Interactive eliminates the redundancies associated with paper-based study start-up and TMF management. Stakeholders have real-time access to clinical trial documentation, and travel and shipping costs associated with paper review and reconciliation are drastically reduced.
Agility chose Trial Interactive for its versatile functionality, with modules for e-feasibility, study start-up, eTMF, document management, and training/learning management. Trial Interactive offers Agility an end-to-end e-clinical solution to streamline their processes and increase transparency with their sponsor clients.
Agility Executive Vice President of Project Management and Clinical Operations, Kristi Clark says, “Use of an eTMF system provides a multitude of benefits to our clients and staff, including real-time access to study documents, consistency in naming and filing of regulatory documents, and increased efficiency as the need for manual tracking and filing is eliminated. We chose Trial Interactive because it is a cloud-based system which allows us accessibility to our documents from anywhere and gives our clients transparency into their TMF at all times. In addition, the system can be customized to better serve the needs of our clients while accommodating different study designs and document requirements.”
Michael Smyth, General Manager of TransPerfect Life Sciences Solutions, stated, “We were excited to be selected as the eTMF provider by Agility Clinical, a highly specialized CRO and consultancy with an excellent reputation. Since the launch of Trial Interactive nearly a decade ago, our goal has always been to assist our clients in maximizing TMF health and to enable them to function in a paperless environment that is user-friendly for stakeholders, no matter where they are.”
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, visit www.trialinteractive.com.
About Agility Clinical
Agility is a niche CRO focused on the needs of pre-clinical and clinical stage companies and specializes in complex trials and rare diseases. The Agility team has an extensive track record conducting trials and preparing data for regulatory submissions leading to product approval. Founded in 2012 by an experienced executive team and employee-owned, Agility won the ROAR (Rare and Orphan Advocacy and Research) award for best CRO for two consecutive years against several well‑known CROs. Our team is experienced, efficient, and dependable, yet creative and committed to our clients and the patients they are trying to help. Agility has established operations in Carlsbad, CA.