Opening Keynote: Decentralized Clinical Trials & Its Impacts on the TMF World

Decentralized clinical trial super hero and former Clinical Innovation Head at Pfizer, Craig Lipset will be introducing the world of Decentralized Clinical Trials & the potential impacts on Trial Master Files.

Craig Lipset
Former Head of Clinical Innovation at Pfizer
Founder, Clinical Innovation Partners
Co-Chair of Decentralized Trials & Research Alliance
‍

Introduction to TMF Week 2021 from the Advisory Board

Paul Fenton
President & CEO

Jamie Toth
Sr Dir, Clinical Systems

Dawn Niccum
Sr Dir, Clinical & Quality Assurance

Donna Dorozinsky President & CEO

Fran Ross
‍TMF Practice Director

Presentation announced shortly

We are putting the finishing touches on this presentation title and it will be announced shortly. Check back here for updates.

The Benefits of AI in eTMF: How to Better Your Overall eTMF health and Quality with New Technology

Working with multiple data sources (CROs) etc. can significantly challenge data standardization and efficient intake of content to the eTMF. Data and content may be delivered, uploaded and indexing with wide variations, leading to poor quality, challenging our TMF inspection readiness. This session will focus on how to utilize emerging technologies such as AI to significantly improve TMF data quality while decreasing the need for manual data enhancement and QC.

Franciska Darmer
Advisory Director, Global Head of Clinical

Bridging the ISF-TMF Divide: What Roles Should Sponsors & Investigators Play?

In this insightful presentation Thomas will look at how the demarcation of the primary roles of sponsor and investigator and their associated responsibilities shape the structure of the TMF and inform the current challenges of TMF and ISF integration and inspection readiness.

Thomas Cocciardi
‍Medical & Technical Writer
‍

The Foundation of the Clinical Trial Story starts with Study Startup

The trial master file is the story narrator of a clinical trial, wherein study startup lays the foundation for the study documenting when all components are ready and qualified to execute the study. Critical to getting the story right from the beginning is the ability to visualize its outline.  A staggering 53% (131 artifacts of the 249 TMF Reference Model artifacts) are associated to milestones prior to site activation, underscoring the significance of these preliminary activities prior to the study enrolling patients.  This presentation will cover the site components and present a map to document the study startup story.

Elvin Thalund
‍‍Senior Director, Product Strategy

Jennifer Wilson
‍‍Director, TMF Operations

Presentation announced shortly

We are putting the finishing touches on this presentation title and it will be announced shortly. Check back here for updates.

Managing Site Records During a Pandemic: A Case Study

Working with multiple data sources (CROs) etc. can significantly challenge data standardization and efficient intake of content to the eTMF. Data and content may be delivered, uploaded and indexed with wide variations, leading to poor quality, challenging our TMF inspection readiness. This session will focus on how to utilize emerging technologies such as AI to significantly improve TMF data quality while decreasing the need for manual data enhancement and QC.

Matt Lowery
‍Director of Clinical Research

The Many Changing Faces of Sponsor Oversight and How the TMF Fits in!

Sponsor oversight is a phrase that can mean a lot of different things to different people. Join me for a guided tour of the different ideas and activities that can fall into this category. What part does the TMF play in enabling all this? I will outline some of the things which seem like good practice and point out some common pitfalls. I’ll finish by trying to outline what things might look like in a utopian future some years from now.

Trial Master Files (TMFs) through the eyes of a Clinical Study Associate

Hear the perspective of the TMF from the front line of Clinical Operations! Learn about the various ways Clinical Study Associates incorporate the TMF into their day to day role and the importance of why the TMF is needed. We'll give you an overview of the use of the TMF from the perspective of a Clinical Study Associate from pre-start to close out including how the Clinical Study Associate benefits from the TMF.

Nicole Weigel
‍‍‍Senior Clinical Study Associate

TMF Oversight in a Multi-Vendor Ecosystem

Do you have multiple eTMF systems? Multiple vendors? And now you need to implement or improve your oversight processes? Come learn a few tips on how to build or improve oversight within the many complexities of a multiple eTMF and vendor ecosystem.  We will cover key elements of oversight, why it is important and  how to implement an effective oversight process that will not only find the findings, but also ensure they are in a remediated and closed state.

Steph Viscomi
‍Associate Director, TMF Operations

PANEL DISCUSSION: Data Driven Deliverables – the D3 of Sponsor Oversight

'Oversight, Oversight, Oversight!  The Regulatory Authorities talk about oversight and the importance of it and the sponsor ‘maintaining oversight’ even if a CRO is involved and managing the trial.  No matter what kind of trial you running, oversight has to be done.Data is needed to support oversight, whether it comes in the form of weekly status update, a metrics report, or something else.  In this panel, hear from sponsor companies and CROs on how this can be achieved successfully as well as how the COVID-19 pandemic, evolving systems and metrics may have increased the need for oversight as well as the move to a risk based approach to oversight.

Jamie Marie Toth
‍Sr Director, Clinical Systems & Records
‍

Mary Brantner
‍‍Sr Director, Global Development Operations

Amofa Osei
‍‍Sr Director, Records Management Compliance

Kate Santoro
‍Director, eTMF
‍

Tonia Huggins
Director, TMF Operations
‍

Karen Freid
‍Essential Documentation Lead
‍

How to Avoid Last Minute Inspection Chaos - Periodic Review of the TMF

“Oh No! – It’s time for an inspection or archiving and our TMF is a mess so we have to scramble at the last minute”. Don’t get caught in a situation where you haven’t reviewed your TMF in months (or years). In this session Dawn & Richard will cover inspection readiness best practices and some key tips to ensure your inspections are succesful by performing regular periodic reviews.

Dawn Niccum
Sr Director of QA & Compliance

Richard Golden
‍Manager, TMF Operations

Bear Traps and Honey Pots: Standardising Document Management Approaches to Real-World Studies

Discover the "pain points" of Real-World Studies vs GCP Clinical Trials as well as understanding how the RWS climate is changing and impacting on study design and conduct. We will also cover how Real-World Study Master Files are created as well as the good document practices that should be observed during real-world studies.

Russell Joyce
Director & Principal Consultant

Stuart McCully, PhD
Founder

Standardization of (e)TMF: Drawing parallels in Industry

Data and document standards have existed for some time within the clinical trials arena and are considered essential for the identification, management and exchange of clinical trial information between stakeholders and systems. These standards cover everything from clinical data collection to regulatory submissions. TMF is the final frontier when it comes to standardization, and standardization is still in its infancy. Having said that, there is a strong case for standardization and this presentation will explore that opportunity by drawing parallels with other areas of clinical trial conduct and discuss how we could take similar approaches to TMF and eTMF.

Paul Fenton
‍‍‍President & CEO

PANEL DISCUSSION: Updates to ICH GCP – How Quality by Design impacts the Trial Master File?

With the anticipated updates to ICH E6(R3), Quality by Design and Risk Management will be raised to the forefront in Clinical Trials. How will this impact the population and management of the TMF? What TMF practices already point to Quality by Design? How will use of metrics drive the focus of the quality of the TMF? How are you “designing” your TMF to drive quality? Attend this panel to find out
‍

Dawn Niccum
‍Sr Director, QA & Compliance
‍

Barbara Novak
‍‍Associte Director, Clinical Operations Systems & Process

Judyth Zahora
‍‍Dir, GCP Quality Risk Management & Process Improvement

Jim Markley
‍‍TMF Project Lead