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A Paragon of Collegial Excellence Wrought by a Participant-Focused Approach

Participants return to work informed, equipped, prepared and inspired to see their TMF to its full potential!

Come and learn from the best with the best!
The collegiality of the speaking faculty is matched by the fellowship among participants. The synergy among the participants that constitute the TMF community at this event is fueled by a shared drive for continuous improvement. This event is truly by, for, and of the participants.

Returning customers are happy customers.
Greater than half of the participants at the 7th TMF Summit had attended at least one of ExL’s TMF summits previously. The majority of attendees attended as a group.

Bigger is not better — unless it is.
The prominence and annual growth of this event is a testament to the value and impact of the learning, networking, professional development and overall experience to the everyday success of participants.

Continuous Improvement
The 2018 summit featured 40% more sessions and 30% more speakers than 2017. The 8th TMF Summit will continue to expand offerings by adding a third track on day two so that participants may better tailor their experience to their particular needs. Takeaways include:

  • tactics for streamlining operations
  • strategies for collaborating with CROs
  • ideas for embedding inspection readiness
  • tools for plying risk-based QC for data integrity
  • orientation to the future of automation and AI
  • metrics for oversight of trials
  • information on inspection trends
  • lessons learned to support and develop staff

Testimonials

"It is great to hear from others that do what I do and understand my concerns and offer solutions. It really helps my confidence that I am doing what is best regarding the TMFs I manage."
—Clinical Document Management Specialist, CR BARD

"The event was very informative and will greatly impact current TMF processes in my role."
—Clinical Research Support Specialist, NUVENTRA PHARMA SCIENCES

"Enjoyed hearing case studies and implementing an eTMF and leveraging metrics."
—Records Analyst, ASTELLAS

"The greatest benefit of this conference was the eclectic background of eTMF/TMF knowledge. I enjoyed getting various perspectives and personal experiences on TMF implementation. The workshops were my favorite; even though I had recently been through a migration into eTMF and Inspection Readiness, I was reminded of critical fundamentals. I learned a great deal about all aspects of TMF from study start-up to archival of TMF. While it was quite a bit of information, it was useful to hear from a variety of clinical research leaders and their personal experiences and their tips & tricks."
—Clinical Trial Assistant, SUCAMPO PHARMA, INC.

Sponsors

Advisory Boards

Wendy Beeby

Director, Clinical Document Management, Operational Excellence

SHIRE
Grace Crawford

VP Clinical Quality and Compliance

MEDIMMUNE
Liz Farell

Senior Manager, Trial Master File

BIOGEN
Joanne Malia

Associate Director, Clinical Documentation Management

REGENERON
Joy Mehlenbacher-Mohamed

Manager, Administration Group

BOEHRINGER INGELHEIM
Curran Murphy

Director, Clinical Operations

DECIPHERA PHARMACEUTICALS
Karen Roy

Chief Strategy Officer

PHLEXGLOBAL
Bryan Souder

TMF Head

MERCK
Jamie Toth

Head of TMF Operations

DAIICHI SANKYO
Vicki Tran

Associate Manager, Clinical Records

SEATTLE GENETICS
Ivan Walrath

Head of Audit and Inspection Quality

PFIZER
Alana Wriggins

Exec. Director, Site Management Operations, Acquisition Integrations and

ALLERGAN PLC

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