Agenda

Evolving the TMF Plan and automating Quality Reviews

This session will provide a review of the Pfizer approach to streamlining the quality and content review process.

Mary Emanoil

The Vendor Selection Blueprint: Getting the right eTMF in-house

This session will help you identify what you should look for in an eTMF system and vendor, including what questions you should consider relating both to system efficiency and solid document management processes.

Kate Santoro

Can Machine Learning Provide TMF Benefits beyond Processing Documents?

If you’re in the TMF community, you’ve probably heard the words artificial intelligence and machine learning thrown around a couple dozen times as conferences and in presentations.

Michael Zwetkow

Paul Fenton

eTMF Product Showcase: Improving Efficiency & Timeliness of TMF Filing in eTMF Connect

In the following product showcase, the Montrium team will be exploring how sponsor and CRO teams can improve TMF filing and efficiency of TMF reconciliation using some of eTMF Connect's leading TMF functionality.

Lyndsey Kirwan

Chris St Amour

Panel Discussion - The Future of TMF is NOW!

This panel will focus on discussing current and future trends in relation to eTMF technologies and how they meet the challenges of the future.

Paul Fenton

Allison Varjavandi

Vittoria Sparacio

Bryan Souder

Franciska Darmer

TMF Oversight & Quality

Tuesday, May 17th

We'll be covering all things oversight and quality on day 2 with talks on sponsor and CRO collaboration, site oversight and management and much more

Day 2

May 17, 2022

TMF & ISF: What is keeping sites up at night?

In this session, we’ll be outlining a collaborative approach to understanding operations, processes, and the appropriate oversight required by sites to make a healthy TMF.

Aryn Knight

Matt Lowery

No budget, no team, no buy-in: How to TMF without everything you need

In this session, we’ll explore how to implement a TMF ops function when you may not have the infrastructure, resources, budget, or technology many have come to expect in the last few years.

Belinda Mabe

Your CRO has the TMF: Don’t Be Scared!

In this session, discover what it takes to establish and maintain a healthy eTMF that works for your team while ensuring a high level of quality and oversight.

JP Miceli

Leila Ponce

eTMF Product Showcase: Getting better sponsor oversight and drilling down into your study health in eTMF Connect

In the following product showcase, the Montrium team will be exploring the eTMF Navigator, managing document statuses, completeness and timeliness reporting to improve sponsor oversight.

Lyndsey Kirwan

Aviv Lubell

Overcoming Challenges in TMF Quality & Oversight in a New Virtual & Decentralized World

Synopsis will be added shortly

Stephanie Viscomi

Dawn Niccum

Kate Santoro

Supriya Shoroff

TMF Operations & Processes

Wednesday, May 18th

The intersection between Sponsor and Site Trial Master File (TMF) lies in the processes, standards and technology supporting the TMF. Day 3 will tackle this and more.

Day 3

May 18, 2022

Switching gears, why upgrading your eTMF can lead to better outcomes

We will present a case study on how the two organizations partnered to switch gears and level up TMF processes, seeing over an 80% increase in efficiency in documentation management, a significant improvement in oversight and a 65% increase in timeli

Lyndsey Kirwan

Kimberly Cagle-Swint

Developing an efficient TMF management process with a lean clinical team

How can smaller companies efficiently execute an audit-ready eTMF with a small yet nimble “Lean” team?

Patrick Smith

Become a Better Storyteller and Implement a TMF Maturity and Process Model

In the following presentation, Donatella Ballerini, will be providing practical guidance on how to take a step-by-step approach to TMF process maturity and will share the path to implementing a TMF process maturity.

Donatella Ballerini

eTMF Product Showcase: Streamlining author productivity with built-in workflows and word collaboration

In the following eTMF Product Showcase the Montrium team will be exploring how an eTMF can be much more than a repository, demonstrating the functionality you need to streamline author productivity.

Lyndsey Kirwan

Oliver Pearce

Inspections, Standards & Regulations

Thursday, May 19th

Regulations are always changing and it’s essential to keep up to date with not only the current state of affairs, but also what’s to come in TMF.

Day 4

May 19, 2022

TMF Inspection Readiness - From Chaos to Calm

We’ll explore how to assess your inspection readiness, including risk-based tools and approaches considering timeline and resource constraints.

Laura Wiggins

Finding your way through the Matrix of Data Integrity

In this session, learn about the importance of ALCOA+ Principles, the foundation to Data Integrity.

Jamie Toth

Building TMF resilience in an ever-evolving clinical trial landscape

This session will feature practical solutions to driving TMF resilience in an ever-evolving clinical trial landscape.

Fran Ross

TMF Fireside Chat: Ask-the-Experts ANYTHING

The TMF Fireside Chat - where the audience will have the chance to bring any—and we mean ANY—TMF-related question to our panel of experts.

Fran Ross

Paul Fenton

Dr. Robin Farmer

Etienne Hinton

JP Miceli

TMF Health & Metrics

Friday, May 20th

The final day of TMF Week will take a deep dive into TMF health & metrics. Learn how to make your metrics work for you.

Day 5

May 20, 2022

Making TMF Change Personal: Building Accountability into your Metrics Program

Join the Syneos Health team to discuss considerations when looking at differentiating between study-level TMF KPIs and KPIs focused on the individuals within the TMF process.

James Martin

Crystal Gallagher

What would I find in your TMF? Top 10 problems and the best practices to avoid them

Join me for a whistle-stop tour of these potential TMF pitfalls, how to find them, and what to do about them.

Daniel Bennett

TMF Metrics: They aren’t just for marketing anymore!

This presentation will discuss how TMF metrics can be used to assist with TMF health and reducing risk, in addition to how they can be leveraged to provide evidence of vendor oversight.

Joanne Malia

Trial Master File Trivia – Pub Quiz with Oliver Pearce & Rob Jones

To cap off what will be our biggest TMF Week yet, our resident TMF Week master of ceremonies, Oliver Pearce, will be running a pub quiz-style trivia game with big prizes to be won! This is not a session to be missed.

Oliver Pearce

Rob Jones