TransPerfect Life Sciences to Provide Practical Guidance at Annual TMF Summit

Global TMF Experts Will Discuss Helping Sponsors Reduce Risk with Effective Vendor Selection, Audit Trail Vigilance, and More

NEW YORK, October 19, 2021 – TransPerfect Life Sciences, a leading provider of services and technologies to support global clinical trials and product development for the biopharmaceutical industry, today announced its Trial Interactive eClinical innovation team will be leading and participating in three TMF-focused sessions at the 10th Annual Trial Master File Summit.

Industry thought leaders and TMF experts Gillian Gittens, Director, eClinical Strategy & Solutions, and Laurel-Ann Schrader, Director, Client Solutions, will lead two sessions: a workshop and a general session.

• Working with TMF Vendors (Monday, October 25, 10:00 AM EDT): This workshop will provide a guide for sponsors to pick a TMF vendor who understands their organization, supports their goals and objectives, and helps ensure an inspection-ready TMF.
• Everything You Need to Know About Audit Trails (Tuesday, October 26, 11:00 AM EDT): This session will define what an eTMF audit trail is and discuss why an eTMF audit trail is required, the elements of an eTMF audit trail, necessary audit trail capabilities, and audit trail reviews.
• TMF Roundtable (Tuesday, October 26, 6:30 PM EDT): Additionally, Gittens and Schrader will take part in a Q&A roundtable discussion where they will share perspectives with other roundtable participants on best practices for effective TMF management.

Gittens and Schrader are annual participants in the TMF Summit and contributors to the TMF Reference Model, and Gittens is an active member of the TMF Reference Model Steering Committee. With decades of experience between them, they lead TransPerfect’s Trial Interactive’s TMF services, with Gittens also acting as eClinical strategist for the Trial Interactive platform. Their expertise spans all functions of the TMF and they frequently conduct customer workshops and expert webinars to help keep industry peers informed on trends, strategies, and best practices for successful TMF management and inspection readiness.

“Gilliin and Laurel-Ann are two of the most knowledgeable TMF subject matter experts in the industry,” commented Michael Smyth, Division President of TransPerfect Life Sciences. “Their sessions always deliver practical advice for clinical operations, demonstrating great insight into the needs, challenges, and goals of TMF teams. Sponsors of any size managing a TMF should check out their sessions.”

TransPerfect President and CEO Phil Shawe stated, “The TMF Summit’s hybrid approach makes it possible for subject matter experts like Gillian and Laurel-Ann to join from anywhere in the world to discuss strategies for operational growth. We’re proud to sponsor the TMF Summit and share information that can lead to faster development timelines by expediting processes and keeping study teams inspection ready.”

To speak with TransPerfect’s TMF experts and get support with your TMF, contact us at info@trialinteractive.com.

About Trial Interactive

TransPerfect’s Trial Interactive is an industry leader in practical eClinical innovation that simplifies and automates clinical processes for sponsors, CROs, and sites around the world. The 21 CFR part 11 compliant unified platform delivers an author to archive collaboration experience with solutions for clinical document management, site selection, site activation, e-learning, compliance training, quality, CTMS and more with seamless solution interoperability and indexing to the eTMF. Trial Interactive is consistently selected by clinical professionals for providing the most comprehensive yet intuitive experience with the most complete offering of technology and expert TMF services. Trial Interactive helps study teams streamline their operations by cutting unnecessary expenses, expediting timelines, reducing compliance risks, and improving operational excellence. For more information on Trial Interactive, please contact info@trialinteractive.com or +1 212.400.8848, or visit www.trialinteractive.com.

About TransPerfect Life Sciences

TransPerfect Life Sciences specializes in supporting global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Our comprehensive solutions include eTMF and eClinical technologies, paper TMF migration, pharmacovigilance and safety solutions, translation and language services, and call center support. With offices in over 100 cities worldwide, TransPerfect is the ideal partner to ensure that your global launch makes a global impact. For more information, please visit our website at https://lifesciences.transperfect.com/.