A Virtual Conference for Trial Master Files

JUNE 1ST - 5TH

TMF Week is the largest FREE online event dedicated entirely to Trial Master Files and how you can improve your TMF processes.

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5 Unique Tracks

Over 5 Days

DAY 1

TMF FUNDAMENTALS

DAY 2

ETMF IMPLEMENTATION & MIGRATION

day 3

TMF QUALITY & PROCESS OPTIMIZATION

COVID-19 is impacting almost every aspect of day-to-day life. But for many organizations, while it may not be "business-as-usual" - business must go on. During the following online conference, we will hear from some of the most experienced and innovative TMF minds in our community on a wide range of topics and themes. Register for TMF Week now and get access to 5 days of unique sessions from over 20 speakers, with no registration fee.

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Free Trial Available

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Day 4

TMF STRATEGY & OUTSOURCING

Day 5

TMF HEALTH & INSPECTION READINESS

Who should attend?

TMF Week is an online conference for life science professionals focused on Trial Master Files. Over the course of the event we'll be covering a wide range of topics from TMF Fundamentals to Regulatory Inspections.

Clinical Operations

- Clinical Operations Leaders
- Clinical Trial Coordinators
- CRAs & CTAs
- TMF Managers

Regulatory Affairs

- Regulatory Affairs / Operations Leaders
- Regulatory Affairs
- Regulatory Operations

Information Technology

- IT Leaders
- eTMF System Owners
- System Architects
- Records Managers / Archivists

Quality Assurance

- Quality Assurance Leaders / Managers
- Validation Associates
- Compliance Analysts

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Our Speakers

Hear from the top Trial Master File experts and ambassadors of our community

Paul Fenton
President & CEO
Jamie Toth
Head of TMF Operations
Sholeh Ehdaivand
President & CEO
Marie-Christine Poisson-Carvajal
Head of TMF
Fran Ross
TMF Practice Director
Sara Dean
Director, TMF Operations
Nick Hargaden
Associate Director, Clinical Systems
Dora Endreffy
Global Records Manager
Jamie O'Keefe
Managing Partner
Monica Alaimo
Director, TMF Operations
Donna Dorozinsky
President & CEO
Philip Lange Møller
Former Regulatory Inspector
Katherine Cianciarelli
eTMF Product Owner
Dorte Frejwald Christensen
eTMF Product Owner
Mayeesha Rahim
eTMF Product Specialist
Laura Naranjo
Associate Director, TMF Operations
Anne-Mette Varney
TMF Process & Systems Manager
Christina Mantzioros
Director, Customer Experience
Sean Lynch
Director of Study Operations
Harper Scott
RA, Trial Operations
David Ives
Director, Head of TMF Operations
Meghan Kellam
Director, Clinical Data Management
Christina Allen
Senior Specialist, TMF
Michelle Savage
Senior Consultant
Dawn Niccum
Senior Director, QA & Compliance
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Speaking Agenda

Join us for 5 days of virtual presentations from the industry's leading TMF experts

MONDAY JUNE 1ST - DAY 1

TMF Fundamentals
Back to basics

How to Implement the TMF Reference Model

9am EDT / 6am PDT / 3pm CET

30 minute presentation + 15 mins for questions

Since its release in 2010, The DIA’s TMF Reference Model has proven to be extremely valuable to the life sciences industry. In this content-packed webinar, we will provide a history and overview of the Model, present its structure, and the various sub-groups and resources available. The Model is not intended to be used “off-the-shelf" but can be implemented according to certain expectations and requirements of life science sponsors (pharma, bio, device), investigative sites (academic, for-profit, nonprofit) and CROs / third-party team members alike.

Fran Ross

TMF Practice Director

Paul Fenton

President & ceo

TMF Fundamentals - An Introduction to Better Trial Master File Management

10am EDT / 7am PDT / 4pm CET

30 minute presentation + 15 mins for questions

Explore the TMF fundamentals and how to better manage your TMF. We start by diving into the world of TMF management, how to properly leverage the regulations, which documents constitute as TMF-worthy and what basic metrics you can track to increase the efficiency of your trial. Finally, we also dive into some of the features Montrium has developed to facilitate the management of the Trial Master File in a fundamental way.

Katherine Cianciarelli

etmf product owner

Mayeesha Rahim

product specialist

Reimagining Clinical Trial Documentation: a Hybrid eTMF and eISF Model

11am EDT / 8am PDT / 5pm CET

30 minute presentation + 15 mins for questions

Investigator sites participating in industry clinical trials are expected to establish and maintain a comprehensive Investigator Site File throughout their trial participation. Many essential documents expected at the site level are already present in the sponsor-established Trial Master File; the TrialSpark Hybrid eTMF and eISF model, leveraged in Montrium eTMF Connect, eliminates duplicative work, unnecessary monitoring and site-level ISF/TMF Health uncertainty. By granting Investigators and site staff restricted access to the applicable zones of the TMF, TrialSpark is able to maintain a highly accurate TMF while also engaging the site more directly as they submit documents directly to the study TMF. By reimagining the way we approach TMF documentation we are able to actualize TrialSpark's mission; to bring new study treatments to patients faster and more efficiently."

Sean Lynch

Director, study operations

Harper Scott

Regulatory Associate, Trial Operations
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TUESDAY JUNE 2ND - DAY 2

eTMF Implementation & Migration
All you need to know about eTMF implementation

Agile eTMF Implementation Applying Machine Learning for Migration

9am EDT / 6am PDT / 3pm CET

30 minute presentation + 15 mins for questions

Dorte Frejwald Christensen

eTMF Product owner

Michelle Savage

Senior consultant

Implementation & Adoption: Lessons Learned in Smaller Organizations

10am EDT / 7am PDT / 4pm CET

30 minute presentation + 15 mins for questions

- Understand the journey of integrating an eTMF, starting with implementation
- Define a long-term strategic plan to outline success factors, vendor selection, and technology to re-engineer your business processes
- Analyze effective collaboration between business and IT roles
- Discuss good governance principles that both engage management and empower teams
- Embrace realistic expectations of success while always being ready to adapt and improve

Nick Hargaden

Associate director, clinical systems

Meghan Kellam

Director, Clinical data management

Practical Steps to Selecting and Implementing an eTMF

11am EDT / 8am PDT / 5pm CET

30 minute presentation + 15 mins for questions

There are many benefits to moving to an electronic Trial Master File (eTMF) and many organizations are either thinking of moving, or are already in the process of doing so. However, there are a great deal of things to consider before being able to successfully move to an electronic platform which are often overlooked, often resulting in unsuccessful or sub-optimal eTMF implementations. This webinar takes you through some of the practical steps that you need to go through to successfully implement and benefit from an eTMF.

Sholeh Ehdaivand

President &CEO

Paul Fenton

President & ceo
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WEDNESDAY JUNE 3RD - DAY 3

TMF Quality & Process Optimization
Ensuring Quality in your TMF Process

Leverage the Power of your TMF to Improve Study Quality

9am EDT / 6am PDT / 3pm CET

Instituting good TMF management practices will help you maintain an updated, comprehensive, and audit-ready TMF. This session will examine how sponsors and CROs can leverage the power of the TMF in assessing and impacting quality to deliver value across the study.

The webinar will discuss:
-Identifying gaps in site training
-Identify clinical site monitoring gaps
-Identifying gaps in sponsor oversight activities

Donna Dorozinsky

President & CEO

TMF King: How to Reign in your Clinical Trial Documentation

10am EDT / 6am PDT / 4pm CET

Sholeh Ehdaivand

President & CEO

How to Approach Process Optimization and Harmonization Across R&D Systems

11pm EDT / 8am PDT / 5pm CET

Jamie O'Keefe

Managing Partner
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THURSDAY JUNE 4TH - DAY 4

TMF Strategy & Outsourcing
Strategic Outsourcing & Sponsor Oversight

The Evolution of eTMF - Building the Next Generation eTMF Systems

9am EDT / 6am PDT / 3pm CET

30 minute presentation + 15 mins for questions

As more and more clinical researchers adopt eTMF systems, storing TMF records electronically has become the norm. There is still much to be done though to truly leverage the value that the eTMF could provide for the improved management of clinical operations. In this session, we will discuss some of the features that we should expect to see appearing in our next generation's eTMF solutions. We will look at the use of AI to improve metrics and TMF health, data and process driven approaches to TMF management and navigation and integration strategies with other non-eTMF systems.

Paul Fenton

President & ceo

Reaching an Effective TMF Process using Sponsor eTMF system and CRO eTMF system

10am EDT / 7am PDT / 4pm CET

30 minute presentation + 15 mins for questions

Syneos Health will speak to their various experiences working with Sponsors who have obtained their own eTMF systems. Sponsors identify a need to maintain their own eTMF systems to maintain their own efficiencies while the CRO also has their own eTMF systems and efficiencies.

Sarah Dean

Director, TMF operations - head of enablement

Monica Alaimo

Director, TMF operations - Head of client accounts

Strategies for Managing TMF Health with Effective Sponsor Oversight

11am EDT / 8am PDT / 5pm CET

30 minute presentation + 15 mins for questions

Laura Naranjo

Associate Director, TMF Operations

Christina Allen

Senior Specialist, TMF
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FRIDAY JUNE 5TH - DAY 5

TMF Health & Inspection Readiness
Regulatory Inspections & Essential Trial Master File Metrics

The Future of Regulatory Inspections in a Post COVID-19 World

9am EDT / 6am PDT / 3pm CET

30 minute presentation + 15 mins for questions

Philip Lange Møller

Former Regulatory Inspector

Best Practices for Preparing for and Surviving TMF Inspections

10am EDT / 7am PDT / 4pm CET

30 minute presentation + 15 mins for questions

Inspections are the apex of the clinical trial. It is something that we prepare, plan for, and ultimately dread for the entire duration of the study. Being inspection-ready can take a significant burden off your clinical team, maximize time, and get your product to market faster.

In this session, we will be exploring the best practices for preparing and surviving TMF inspections. We'll start by diving into why inspection readiness should be continuous, and share some key strategies to ensure your team has a successful inspection. We will also demonstrate some tools that give your clinical teams an edge when it comes to surviving inspections, and provide your team with greater oversight into eTMF completeness.

Dawn Niccum

Senior Director, QA & Compliance

Christina Mantzioros

Director, Customer Experience
PANEL DISCUSSION

The Future of TMF - Evolving Regulations, Technologies & Processes

11am EDT / 8am PDT / 5pm CET

90 minute panel discussion

In the closing session of TMF WEEK, we've assembled an avengers-like cast of TMF Experts to talk all things Future. This panel discussion will dive into the future of eTMF systems, Evolving Regulations, Continuous Evaluation, Remote Inspections plus much more.

Paul Fenton

President & CEO

Jamie Marie Toth

Head of TMF Operations

Dora Endreffy

Globabl Records Manager

Marie-Christine Poisson-Carvajal

Head of TMF

Sholeh Ehdaivand

President & CEO

David Ives

Director, Head of TMF
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It's FREE to register!

Fill out the form below to register for all sessions. Then simply decide which sessions you want to attend.

Frequently Asked Questions (FAQ)

When will TMF Week take place? Where is it located?

June 1st - June 5th completely online. TMF Week is a virtual online event where you can join from the comfort of your own home.

How can I register?

Registration is as easy as filling out a form. It's also completely FREE to attend with no registration fee.

Is it possible to attend only one session/day?

Yes. Much like a physical conference, your registration gets you access to all of our talks. You decide which ones you want to attend.

I haven't received a confirmation email, what should I do?

If you have received a confirmation email for TMF week, please email marketing@montrium.com and we'll send you over your confirmation email.

Who organizes TMF Week?

TMF Week is organized and coordinated by Montrium, a leading eTMF platform provider. However, this event wouldn't be possible without its amazing speaking faculty.

Are TMF Week sessions recorded?

Yes, all of TMF Weeks sessions are recorded and made available to registrants after the conference has completed.

Have questions about TMF WEEK?

If you want more specific information about TMF Week or would like to get in touch with the organizers. Please fill out the following form.

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