Agility Clinical Chooses TransPerfect as eTMF Provider

NEW YORK–(BUSINESS WIRE)– TransPerfect Life Sciences, a leading provider of global development and
commercialization solutions to the life sciences industry, today
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 sponsors 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 on Trial
Interactive, please contact info@trialinteractive.com
or +1 212.400.8848, or 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.

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