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Wednesday, June 26 • 10:30am - 11:30am
#331: A Pharma/CRO Partnership in the Design and Execution of Paperless Clinical Trials from eICF to Database Lock

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-680-L04-P; CME 1.00; IACET 1.00; RN 1.00

The paperless clinical trial is a paradigm shift that must occur to enable the clinical trial enterprise to embrace the modern era. We will share our experience partnering, planning, and implementing these trials to assure that there is no compromise on patient safety, data integrity, trial efficiencies and regulatory review.

Learning Objectives

Describe the elements of the paperless clinical trial and how it differs from paper-based studies; Discuss the paradigm shift and its impact on the clinical trial stakeholders; Identify how to plan and implement the paperless clinical trial.

Chair

Jules T Mitchel, PhD, MBA

Speaker

Paperless Clinical Trial
Michelle Eli

Paperless Clinical Trial
Thomas Haag



Speakers
avatar for Michelle Eli

Michelle Eli

Clinical Project Management Advisor, Chorus, Eli Lilly and Company
Michelle Eli has worked in the pharmaceutical industry for 28 years with positions primarily in Clinical Project Management and Pharmacokinetics. She started her career at the former Upjohn Company (now Pfizer) and is currently a Clinical Project Management Advisor within the Chorus... Read More →
avatar for Thomas Haag

Thomas Haag

Principal Consultant, Cardinal Solutions Consuting, LLC
Tom Haag has a truly innovative vision for quality in clinical research that is focused on delivering outcome data that justifies therapeutic costs. Formerly the Global Head of Digital Development and Transformation QA with Novartis, Tom led on end-to-end quality and data integrity... Read More →
avatar for Jules Mitchel

Jules Mitchel

President, Target Health, Inc.
Dr. Mitchel is President and co-founder of Target Health Inc., a New York City-based full service eCRO dedicated to all aspects of Drug and Device Development. He also leads the team at Target Health developing software tools to enable the “Paperless Clinical Trial.” Dr. Mitchel... Read More →


Wednesday June 26, 2019 10:30am - 11:30am
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session