The #1 Trial Master File Event on the Planet

Completely Incomplete: Seeing Through the TMF Completeness Mirage

In this session we will discuss why it is so challenging to establish accurate completeness metrics and approaches that we could take to improve accuracy and efficiency when evaluating the completeness of our TMF.

Paul Fenton

Inspection Aftermath: Digging yourself out of CAPA hell

Inspections can feel like a brutal type of hell… long hours of prep, countless meetings, laundry lists of requests and the constant worry of “are we ready? … inspection ready??”

Dawn Niccum

Stephanie Viscomi

Panel Discussion: The File Frontier: What will eTMF look like in the future?

In this panel we will discuss future trends and features that we expect or would like to see in our eTMF.

Paul Fenton

Franciska Darmer

Claire Schenkel

Nisi Nazim

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.

Chris St Amour

Oliver Pearce

Extreme Makeover TMF Edition: Building a DIY eTMF transfer process

In our industry, compliance with health authority regulations is essential, but how do Sponsors and CROs manage this for transfers of eTMF that require data harmonization and data privacy protection? We discuss some best practices for transfers, GxP

Angel Ramos

MaryJane Colon

Put the control back in QC: Encouraging a quality mindset before documents get to the TMF

In this session, Bobbi Wells from Chimerix will explain how adopting a "right the first time" methodology can help you to confidently pass QC and inspection readiness reviews.

Bobbi Wells

Day 2

Tuesday, May 16th

Check out the full program schedule below. All times are in Eastern (ET) timezone

Day 2

May 16, 2023

Your not-so-secret weapon for inspection readiness: TMF Health Checks

The TMF is the backbone of clinical trials, and keeping it in tip-top shape is crucial for inspection readiness.

Donatella Ballerini

Creating a TMF Utopia – Isn’t it time we ditched our archivist mindset?

How many times have you heard someone say, “I need to archive this in the TMF” or worse, ask “Do I need to put this in the TMF”? TMF filing is perceived as an extra step “after” the real work of creating and using the document has been done – if the

Meredith Lafond-Phesans

Panel Discussion: Inspection experiences from around the world

This international panel of experts will share what "inspection readiness" truly means to them, including critical tools and best practices.

Jamie Toth

JP Miceli

Hobson Lopes

Cristina Monastero

Liz Farrell

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.

Chris St Amour

Oliver Pearce

360° Inspection Readiness: Staying prepared before, during, and after inspection

This session will be a crash course on everything you need to know about regulatory inspections.

Cristina Monastero

Demystifying the TMF vs ISF debate - From the site perspective

In this presentation, Matt and Aryn intend to decipher the difference between the TMF and ISF from a site's perspective.

Aryn Knight

Matt Lowery

Day 3

Wednesday, May 17th

Check out the full program schedule below. All times are in Eastern (ET) timezone

Day 3

May 17, 2023

Charting a course to standardization: The future of the TMF Reference Model

This session will discuss the benefits of the reference model becoming a standard and the activities that are both planned and underway to realize this transformation.

Karen Roy

Paul Fenton

Thinking Differently: Getting the TMF to work for you

We can get ourselves into trouble when we treat the management of the TMF as a separate and distinct activity from managing the trial itself. We often wind up with two sets of books—the Compliance TMF and the Real TMF.

Terry Endress

Panel Discussion: How can we improve TMF culture and engage non-TMF'ers

In this panel session we will discuss practical ways of improving your TMF culture, and how to convince those outside of the TMF space that they are missing out on "Too Much Fun"!

Dr. Robin Farmer

David Ives

Anusha Rameshbabu

Caroline Nielson

Jared Brooslin

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.

Chris St Amour

Oliver Pearce

How to make your TMF Index work for you

The TMF Index should be the simplest tool you use during your clinical trial, but unfortunately that is not always the case. TMF Indices have been used as somewhat of a loose tool that is not utilized as often as it should due to lack of training, ov

India Gardner

Accelerate the implementation of eTMF Systems with Risk-based Validation

This session will review the methodology and things to consider in risk-based validation, to find the sweet spot between 100% requirements testing, and simply accepting the product vendor deliverables.

James O'Keefe

Montrium Customer Day

Thursday, May 18th

In 2023, we're doubling down on building value for our customer community. Day 4 of TMF Week will be completely reserved and restricted to active Montrium customers. All times are in Eastern (ET) timezone

Day 4

May 18, 2023

Customer Keynote: Montrium's vision for eTMF Connect & upcoming roadmap

There are many changes afoot in the TMF world from all perspectives as we move towards an ever more digital environment. There are many exciting opportunities before us and we will be discussing these and how Montrium's long term vision and road map

Paul Fenton

Katherine Cianciarelli

Implementing a Risk-Based QC Workflow in eTMF Connect

Performing risk-based QC of the TMF is not just a nice-to-have process, it is an expectation from the regulators. Implementing this process in eTMF Connect takes only a few simple steps.

Mayeesha Rahim

TMF Training: Designing an Agile Approach to TMF for Inspection Readiness

If you consider your TMF only as the official repository of the essential documents of your clinical trial, you are further away than you think from being Inspection Ready.

Donatella Ballerini