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Brochure   Sponsor   Agenda

Why Clinical Document World Should Be Your Learning & Networking Choice of the Year

  • 45+ Educational sessions cover all aspects of clinical document management including regulatory guidance, compliance, quality, technology.
  • Hear from 50+ leaders with a background in clinical operations, TMF, quality, technology, and inspections.
  • Focus on developing a strategic TMF management plan that increases quality and ensures TMF completeness.
  • Develop and maintain a culture of inspection readiness.
  • Impact of site – Sponsor – CRO collaboration to improve quality
  • Discover new technologies that can assist in document management as well as how to implement and roll them out seamlessly.

Thank You to Our Sponsors and Partners!

Meet Your Faculty

Meet your faculty one-on-one, engage in meaningful dialogue, and participate in live Q&A after each session.

Thought Leaders

Aryn Knight, BS, CCRP


Aryn Knight, BS, CCRP

Administrative Director, Center for Clinical Research
Texas Heart Institute

Martina Duevel


Martina Duevel

Systems Excellence Project Leader
Bayer AG

Jamie Marie Toth, CPM, MS


Jamie Marie Toth, CPM, MS

Director, Head of TMF Operations, Clinical Development Operations
Daiichi Sankyo, Inc.

Donatella Ballerini


Donatella Ballerini

Document and Training Manager, Global Rare Disease R&D
Chiesi Pharmaceuticals

Sholeh Ehdaivand


Sholeh Ehdaivand

President and CEO
LMK Clinical Research Consulting

Ronla Prince


Ronla Prince

TMF Services Lead, Document and Unified Clinical System, Processes and Enabling Solutions
AstraZeneca

Hobson Lopes


Hobson Lopes

Manager, Clinical Archive Management, Regeneron Pharmaceuticals
Regeneron Pharmaceuticals

Stephanie Viscomi


Stephanie Viscomi

Associate Director, TMF Operations
Alexion Pharmaceuticals

Who Should Attend

Life science professionals from Pharmaceutical, Biotech, and Medical Device organizations with responsibilities in

  • Clinical documentation
  • Trial Master File
  • Inspection readiness
  • Clinical operations
  • Clinical technology
  • Quality assurance
  • Risk management
  • GCP
  • Trial, records, document management
  • Clinical document compliance
  • Clinical trial management
  • Clinical innovation/process improvement
  • Clinical development

Sponsoring the Summit

The Clinical Document World Event is the premier event to meet Clinical Documentation, Trial Master File, GCP, Clinical Quality professionals who are looking to improve their processes through strategic improvements and partnerships. Learn more about how we can create a unique sponsor experience for your company. Please contact Kelly Hara.

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