A Virtual Conference for Trial Master Files

Agile eTMF Implementation Applying Machine Learning for Migration

9am EDT / 6am PDT / 3pm CET

Dorte Frejwald Christensen

eTMF Product owner

Michelle Savage

Senior consultant

Implementation & Adoption: Lessons Learned in Smaller Organizations

10am EDT / 7am PDT / 4pm CET

- 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

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

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.
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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

The Evolution of eTMF - Building the Next Generation eTMF Systems

9am EDT / 6am PDT / 3pm CET

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

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

Laura Naranjo

Associate Director, TMF Operations

Christina Allen

Senior Specialist, TMF

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

9am EDT / 6am PDT / 3pm CET

Philip Lange Møller

Former Regulatory Inspector

Best Practices for Preparing for and Surviving TMF Inspections

10am EDT / 7am PDT / 4pm CET

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.
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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