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OpTImize

TMF Roadshow 2026

The OpTImize TMF Roadshow is a series of global, in-person events that bring together leaders in clinical operations and trial master file (TMF) optimization. Each roadshow features presentations from TMF experts and active members of the CDISC Reference Model Steering Committee.

Learn about system-agnostic strategies to maintain a high quality TMF, save time, and reduce inspection risks. Attendance is invite-only, and attendees will also have the opportunity to receive free, personalized consultations on risk-based TMF oversight across various eClinical platforms.

Interested in attending?
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Meet us on the road!

RSVP below for the next stop of Trial Interactive's OpTImize TMF Roadshow 2026! These events are invite-only, so please contact us if you wish to extend this invitation to one of your colleagues, and let us know if you have any questions!

TMF Roadshows Coming to a City Near You

Paris, France | April 28
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Barcelona, Spain | May 14
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Copenhagen, Denmark | June 11
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Boston, Massachusetts | September 29
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Princeton, New Jersey | October 1
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Featured Speakers

TMF Expert and Director, TMF Services

Janice del Rosario

Janice has over 15 years of experience in clinical research across pharmaceutical, biotech and CRO environments. She provides direction and leadership in clinical operations and record management. She has strategic planning and TMF services expertise, including eTMF implementation, process development, business and technology alignment, TMF management, content migration, audit and regulatory inspection readiness, risk management, CAPA implementation, KPI and metrics development, line management, resource and budget planning, and cross-functional team leadership.

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TMF Expert and Director, Client Solutions

Laurel-Ann Schrader

Laurel-Ann is a Certified TMF Manager with over 21 years of experience. She is an active participant and contributor to the TMF Reference Model working groups and is a thought leader in the TMF industry. Her expertise includes TMF inspection readiness, record management, eTMF implementation, and the real-world application of the TMF Reference Model. She previously worked in clinical operations at Ardea Biosciences, ICON, BioPharm Systems, and Amylin Pharmaceuticals.

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TMF Expert and Senior Director, e-Clinical Strategy and Solutions

Gillian Gittens

Gillian is a TMF industry veteran with over 25 years of experience. She offers clients a wealth of insight on managing TMF services and the future of clinical trial record management. She is knowledgeable in clinical research industry best practices, regulatory guidance, and how to support ongoing customer success across all aspects of TMF operations. She is a member of the CDISC TMF Reference Model Steering Committee and Project Management Team leading the V4 initiative.

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TMF Expert and Director, Client Solutions

Avani Amin

Avani joined Trial Interactive in 2018 following a decade-long tenure at an eTMF vendor. Avani advanced to the role of Executive Project Manager, where she oversaw system implementation, provided best practice guidance, and ensured ongoing customer success for TI’s premier clients. With over 15 years in the life sciences industry, Avani has now shifted into TMF consulting. Leveraging her clinical research expertise, she assists clients with industry best practices, eTMF and CTMS optimization, risk-based record management, and SOP/TMF plan creation.

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Agenda Highlights

The OpTImize TMF Roadshow 2026 is part of Trial Interactive's series of in-person events aimed to engage the life sciences community and share system-agnostic education on how to optimize your clinical operations and quality.

You'll hear expert perspectives, connect with industry colleagues, and walk away with clear guidance to strengthen the health of your TMF.

  • TMF Standard V1: Are You Ready?

    Discover the forthcoming TMF Standard Model, new record classification rules, and implementation strategies. Learn practical steps to align with the new standard.

  • Collaborate to Win: Sponsors, CROs & Sites in Harmony

    Unlock strategies to manage multi-stakeholder TMFs with clear roles, robust governance, and real-world lessons from complex trials.

  • Risk-Based TMF Management: Smarter, Not Harder

    Learn how to identify, evaluate, and prioritize TMF risks across the study lifecycle. Gain practical guidance on mitigating risks through real examples.

  • Inspection Steady: Quality That Speaks for Itself

    Learn how to maintain a high-quality TMF and avoid common inspection pitfalls through recent, real-world inspection war stories.

  • Future-Proof Your TMF: Digital Transformation & Next Generation AI

    Explore cutting-edge automated tools that save time, reduce errors, and keep your team inspection-ready without overloading resources.

  • 1:1 Consultations with TMF Experts

    Get the chance to chat directly with our TMF SMEs about your biggest TMF pain points and challenges, completely free of charge.

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