Trial Master File Summit 2021 has ended

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TMF Oversight - Live Streamed to Virtual Audience [clear filter]
Tuesday, October 26

2:00pm CDT

TMF Completeness, Quality and Timeliness: A Deep Dive
  • Understand the main challenges to determining TMF completeness
  • Measuring TMF quality: beyond QC failures
  • The many ways of calculating TMF timeliness
  • The perfect as the enemy of the good

avatar for Kathie Clark

Kathie Clark

Product Director, CTMS and eTMF, Ennov
Kathie is Director, eTMF and CTMS for Ennov. She provides thought leadership for the industry and is the author of many white papers, journal articles and blog posts on eTMF, eClinical and regulatory topics. She is a member of the TMF Reference Model steering committee and has chaired... Read More →

Tuesday October 26, 2021 2:00pm - 2:30pm CDT

2:45pm CDT

Panel: Dive Into eTMF Implementation: Review Lessons Learned
avatar for Grace Crawford

Grace Crawford

Global Head, Clinical Quality & Compliance, AstraZeneca R&D
Grace Crawford is an accomplished quality and compliance leader with over 27 years of experience working with international clinical trials, quality systems, regulatory compliance, and computer systems validation in the pharmaceutical, medical device, and biotech industries across GxP’s (GCP/GLP/cGMP). Her... Read More →
avatar for Martin Frid-Nielsen

Martin Frid-Nielsen

Vice President, Document Solutions, Medidata, a Dassault Systemes Company
Martin Frid-Nielsen is the VP of Document Solutions & Services at Medidata, a Dassault Systemes company. In this role, he oversees the company's R&D efforts for Rave eTMF and other document-based products and services that are used by a broad global audience. Prior to joining Medidata... Read More →
avatar for Jason King-Andreini

Jason King-Andreini

Senior Manager, TMF Operations, Eidos Therapeutics, a Bridge Bio Company
avatar for Liz Farrell

Liz Farrell

Director, Trial Master File, Agios Pharmaceuticals

Tuesday October 26, 2021 2:45pm - 3:30pm CDT

5:00pm CDT

Develop, Communicate, and Maintain Best Practices with Sites – TMF Collaboration
avatar for Aryn Knight, BS, CCRP

Aryn Knight, BS, CCRP

Administrative Director, Center for Clinical Research, Texas Heart Institute
Aryn Knight, CCRP, is Administrative Director at Texas Heart Institute, Center for Clinical Research in Houston, TX. She is a Certified Clinical Research Professional (CCRP) with more than 20 years of direct experience in clinical research in academia and hospital environments. Since... Read More →
avatar for Matt Lowery, ACRP-CP, CCRC

Matt Lowery, ACRP-CP, CCRC

Director of Clinical Research, Suncoast Neuroscience Associates, Inc.
Matt holds the ACRP-CP and CCRC certifications through ACRP and is a member of SCRS, ACRP, MAGI, and SoCRA. He has over 14 years of experience in clinical research on both the site and sponsor level. On the site side, Matt has worked as a study coordinator, site manager, director... Read More →

Tuesday October 26, 2021 5:00pm - 5:30pm CDT
Wednesday, October 27

10:15am CDT

Sponsor Oversight – Process and Technology
avatar for Suliat Oyelami-Davies

Suliat Oyelami-Davies

Associate Director, Clinical Operations Inspection Readiness, Eidos Therapeutics, a Bridge Bio Company
avatar for Jason King-Andreini

Jason King-Andreini

Senior Manager, TMF Operations, Eidos Therapeutics, a Bridge Bio Company

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