Trial Master File Summit 2021: Full Schedule

9:45am CDT

Digital Disruption and TMF Health

Speakers

Sondra Pepe

Associate Vice President, Clinical and Regulatory Product Management, ArisGlobal

Associate Vice President, Clinical and Regulatory Product Management, ArisGlobalSondra Pepe leads product management for ArisGlobal’s Clinical and Regulatory solution portfolios. In this role, she is responsible for defining product strategies and roadmaps, and overseeing the growth... Read More →

Wednesday October 27, 2021 9:45am - 10:15am CDT

Emerging Technology - Live Streamed to Virtual Audience

11:15am CDT

TMF Health Scoring with a Deep Dive on TMF Completeness

Define what metrics contribute to overall TMF Health
How to develop a single TMF Health score
Deep Dive into the creation of a high-quality TMF Completeness metric

Speakers

Jason Weinstein

Sr Manager TMF Systems and Partner Management, Regeneron Pharmaceuticals, Inc.

Jason Weinstein has worked in the pharmaceutical industry for 10 years. He transitioned to TMF and Records Management in 2014, and is currently the eTMF/CTMS Business Lead at Regeneron Pharmaceuticals Inc. In his position, Jason works closely with the various system stakeholders to... Read More →

Soraya Nossoughi

TMF Lead, Regeneron Pharmaceuticals, Inc.

Soraya Nossoughi has worked in the pharmaceutical industry for 10 years. Starting in Clinical Operations and Translational Sciences, she quickly began working in pre-clinical and bioanalytical archives as well as TMF management and oversight. In her current position at Regeneron Pharmaceuticals... Read More →

Wednesday October 27, 2021 11:15am - 11:45am CDT

Emerging Technology - Live Streamed to Virtual Audience

11:45am CDT

Building a Digital Site Footprint for the Future of Patient-First Clinical Trials

In this session, you will learn how pharmaceutical sponsors, medical device companies, biotechs, and CROs are building digital site footprints integrated with their eTMF to support the patient-first clinical trials of tomorrow, today. Real-world examples will be shared of how a global digital network of sites powered COVID vaccine trials on a global level and kept 10,000 study sites operational. During this session, you'll discover how to build a technology strategy and product stack that enables you to bridge the digital divide between sponsors and sites and drive operational effectiveness, quality, completeness, and timeliness while turning on always-on remote access.

Speakers

Blake Adams

VP of Marketing, Florence

Blake is VP of Marketing for Florence and Host of "The Next Phase: Exploring Innovations in Clinical Trials" Podcast. At Florence, Blake has helped to position the company to solve global site access and operational challenges over the past four years. Florence is now the leading digital site technology in use by 10,000 study sites in 27 countries and accessed monthly by every top 100 pharma company. On "T... Read More →

Wednesday October 27, 2021 11:45am - 12:15pm CDT

Emerging Technology - Live Streamed to Virtual Audience

2:00pm CDT

Establish Processes for System Enhancements That Benefit Global End-Users

Leverage Clinical System Framework for system enhancement projects
Capture relevant KPI to measure system performance
Engage with end users – keep them informed and listen to their feedbacks

Speakers

Keith Win, MS

Manager, Clinical Systems (eTMF), Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc.

Keith Win, MS, is a Manager Clinical Systems (eTMF) for Clinical Systems & Records group at Daiichi Sankyo, Inc. (DSI) where he facilitates system enhancement change control projects, data migrations, and metric generation for the eTMF application. Prior to DSI, Keith worked for... Read More →

Wednesday October 27, 2021 2:00pm - 2:30pm CDT

Emerging Technology - Live Streamed to Virtual Audience