2023 CDISC TMF Interchange Presentation Archive
Session 1: Opening Plenary
Dave Evans, Karen Roy, CDISC
Calvert Ballroom / Salon C
Keynote Presentation: How TransCelerate Initiatives Impact the TMF
Dr. Rob DiCicco, TransCelerate BioPharma Inc.
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Session 3A: TMF Reference Model as a Tool
Monica Alaimo, Syneos
Calvert Ballroom / Salon C
TMF Reference Model to improve TMF Management
Jackie Morrill, TransPerfect
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Harnessing the Power of Your TMF Index
Laura Wiggins, Just In Time GCP
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Demystifying Data Management and TMF
Laura Naranjo, Vishaal Patel, Daiichi Sankyo
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Session 3B: TMF Reference Model Becoming a Standard
Paul Fenton, Montrium
Baltimore Theatre
TMF Reference Model (and EMS) Becoming a Standard
Bess LeRoy, CDISC
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An Overview of NCI EVS Services and Its Collaboration with CDISC
Jordan Li, NCI EVS
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A Deep Dive into the TMF Reference Model Change Control
Kate Santoro, Intellia Therapeutics; Leila Ponce, Seagen
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Session 4A: TMF Health
Bryan Souder, Merck
Calvert Ballroom / Salon C
The TMF Trinity and How Simple is Best. The Importance of Timeliness, Quality and Completeness and How They are Early Warning Systems for TMF Health
Robert Jones, Jake McDonald, Phlexglobal
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How to Manage Study Teams and CROs Using TMF Metrics, Action Plans, and Escalations
Jason Weinstein, Regeneron
Session 4B: TMF Interoperability
Sarah Dean, Precision for Medicine
Baltimore Theatre
Data Standardization and Integration: Turning Data Chaos into Data Intelligence
Nisi Nazim, BeiGene
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Clinical / Regulatory Interoperability: A World of Opportunity
Kathie Clark, Ennov
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Leveraging Data Enablement for Enhanced eTMF Interoperability and Colllaboration
Meghan Valnoski, NNIT
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Session 7A: Technology in TMF Management
Donna Dorozinsky, Just In Time GCP
Calvert Ballroom / Salon C
Case Study: How Merck Drives Efficiencies and Quality with AI
Bryan Souder, Merck; Chris McSpiritt, Veeva
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Enhancing Data Integrity by Applying Edit Checks to Your TMF
Christina Mantzioros, Todd Georgieff, Montrium
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Session 7B: TMF Culture and Engagement
Dawn Niccum, Inseption
Baltimore Theatre
Is TMF Really Too Much Fun? Challenging the TMF Culture Through Education and Collaboration
India Gardner, inSeption Group
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Characteristics of the 5 Generations of People and Considerations for TMF Management
Lisa Mulcahy, Mulcahy Consulting
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Session 8A: Sponsor-CRO Co-Operation
Monica Alaimo, Syneos
Calvert Ballroom / Salon C
Sponsor and CRO: Creating a Sustainable TMF Partnership
Alex Markiel, TMF Consultant; Annette Bugno, Biomea Fusion
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Fostering Effective Collaboration: An In-Depth Look at Sponsor-CRO Co-Operation
Yen Phan, elderbrook solutions GmbH
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Session 8B: End of Study
Vittoria Sparacio, Novartis
Baltimore Theatre
End of Study Transfer
Marion Mays & Toban Zolman, Kivo
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Revolutionizing eTMF Archiving and Preservation
Ashley Avery, Cerevel Therapeutics; Antonia Witten, Arkivum
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