Past event: Trial Master File Summit

Elevate TMF Operations by Enhancing Internal and External Collaboration, eTMF Processes, Integrated Technology, and Inspection Readiness

Three days, four workshops, six tracks, and endless amounts of information.

This three-day Summit in the Sunshine State offers attendees premier networking opportunities, access to the TMF community, and endless amounts of educational information to bring back to their teams. Summit participants return to work informed, equipped, and inspired to guide their organization's TMF to its full potential! Focuses and new features of this year's program include:
  • Four workshops for varying experience-levels
  • Inspection experience showcase
  • Functional area collaboration
  • TMF operations
  • Quality and completeness
  • eTMF/technology enhancements
  • Partnerships
  • Inspection readiness

Who Should Attend

This conference is designed for representatives from pharmaceutical, biotech, medical device and clinical research companies with responsibilities in the following areas:
  • TMF/eTMF Systems Management
  • Clinical Document Management
  • Clinical Trial Documentation
  • Clinical Trial Administration
  • Clinical/TMF Project Management
  • Quality Control/Quality Management
  • Clinical Operations
  • Clinical Research Coordination/Management
  • Regulatory Affairs/Operations
  • Trial, Document and Records Management
  • Clinical Document Coordination
  • Clinical Trial Compliance
  • Clinical Development/Study Management
  • Quality Assurance/Control/Operations
  • R&D Quality Management
  • Strategic Operations and Planning
  • Global Development
  • R&D IS Management
This event is also of interest to:
  • eTMF Process Service Providers
  • Data/Records Management Vendors
  • Clinical Research Organizations
  • Paper and Electronic Archiving Solution Providers


  • Evelin Baez, Senior Clinical Operations Specialist - BD
  • Wendy Beeby, Director, Clinical Document Management, Inspection Readiness and Trial Support - TAKEDA
  • Tatsiana Brady, Senior Manager, Audit and Inspection Readiness, Specialty Clinical Development and Global Medical Affairs - TEVA
  • Kristen Bretzius, Manager, TMF Governance - TEVA PHARMACEUTICALS
  • June Buchanan, Director, Clinical Operations - TESARO
  • Jessica Chamberlain, Records Analyst, Central Medical Files - ASTELLAS
  • Dorte Frejwald Christiansen, Competency Development Specialist - NOVO NORDISK
  • Dawn Clowes, Manager, Regulatory TMF - BIOGEN
  • Bill Cooney, President and CEO - MEDPOINT DIGITAL INC.
  • Grace Crawford, Global Head of Clinical Quality and Compliance - ASTRAZENECA
  • Sonja Davis, Associate Senior QA Consultant, QA-Product Research and Development - ELI LILLY
  • Brian Dempster, Director, Clinical Affairs - ENDOLOGIX
  • Ashlyn Deshaies, Clinical and TMF Operations Manager - TG THERAPEUTICS
  • Donna Dorozinsky, President - JUST IN TIME GCP
  • Martina Duevel, Systems Excellence Project Leader - BAYER
  • Jenn Embury, Manager, Clinical Customer Success - VEEVA
  • Liz Farrell, Senior Manager, TMF - BIOGEN
  • Paul Fenton, Founder and CEO - MONTRIUM
  • Karen Freid, Essential Document Specialist - MERCK
  • Patty Fulton, Quality Consultant, Trial Master File - ELI LILLY
  • Gillian Gittens, Customer Success Manager - IQVIA
  • Rebecca Halbur, Senior Manager, TMF Systems - BIOGEN
  • Nick Hargaden, Associate Director, Clinical Systems - AGIOS
  • Etienne Hinton, Clinical Trial Coordinator - DUKE CLINICAL RESEARCH INSTITUTE
  • Aryn Knight, Administrative Director, Center for Clinical Research - TEXAS HEART INSTITUTE
  • Hobson Lopes, Manager, Clinical Archive - REGENERON PHARMACEUTICALS
  • Alex Markiel, Director, Clinical Records Management (CRM) and Trial Operations Platforms, Global Development Operations - PHARMACYCLICS
  • James Martin, Director, TMF Operations - CDS - SYNEOS HEALTH
  • JP Miceli, Associate Director of Document Management - ADVANCED CLINICAL
  • Thomas Miller, Product Delivery Consultant - Design Hub - ELI LILLY
  • Lisa Mulcahy, Owner and Principal Consultant - MULCAHY CONSULTING
  • Curran Murphy, Director, Clinical Operations - DECIPHERA PHARMACEUTICALS
  • Laura Naranjo, Associate Director, TMF Operations - DAIICHI SANKYO
  • Dawn M. Niccum, Senior Director of QA and Compliance - INSEPTION GROUP
  • Vinay Parachuri, Practice Head - Life Sciences - PHARMA TEK SOLUTIONS
  • Marie-Christine Poisson-Carvajal, Senior Director, Head of TMF and Registry Operations - PFIZER
  • Minette Pugh, Advisor, Quality Systems and Compliance Management - ELI LILLY
  • Lori J. Ridge, Senior TMF Project Manager - MYLAN PHARMACEUTICALS
  • Karen Roy, Chief Strategy Officer - PHLEXGLOBAL
  • Pawel Rucki, TMF Operations Manager - GW PHARMACEUTICALS
  • Jay Russak, Clinical Team Lead - DICENRA PHARMACEUTICALS
  • Barry Sacks, Chief Technology Officer - PHLEXGLOBAL
  • Nicole Sheetz, Director, Clinical Design, Delivery and Analytics - ELI LILLY
  • Supriya Shoroff, Head of TMF Operations - AMAG PHARMACEUTICALS
  • Shannon Simpson, Trial Master File and Institutional Review Board Specialist - PATH
  • Jay Smith, Senior Director, Product, Trial Interactive - TRANSPERFECT
  • Joaquin Sosa, Director, TMF Operations - SYNEOS HEALTH
  • Bryan Souder, Director, TMF Head - MERCK
  • Perry Steinberg, GM & VP, Product - MEDIDATA, a Dassault Systemes company
  • Kyle Stephenson, Clinical Product Manager - VEEVA
  • Jamie Toth, Director and Head of TMF Operations - DAIICHI SANKYO
  • Wendy Trimboli, Former Director TMF Operations, Inspection and Strategy - JUST IN TIME GCP
  • Allison Varjavandi, Director, Central Medical Files - ASTELLAS
  • Anne-Mette Varney, Principal Competency Development Specialist - NOVO NORDISK
  • Stephanie Viscomi, Associate Director, TMF Compliance and Education - ALEXION
  • Debra Wells, Sr. Manager, Global Regulatory Systems and Process Management - EISAI
  • Karen Whitson, Assistant Director, Clinical Documentation Center - ABBVIE
  • Keith Win, Senior Business Analyst, TMF Operations - DAIICHI SANKYO

Please fill in your name and email to receive the Summit Agenda of this event.


Sheraton Lake Buena Vista
12205 S. Apopka Vineland Road, 32836
Orlando, FL

To make reservations, guests can call 1-800-423-3297 and request the negotiated rate for this January Meetings. To make reservations online click here.
Event details
Organizer : ExL
Event type : Conference
Reference : ASDE-21711