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Tuesday, June 25 • 2:00pm - 3:15pm
#266: Electronic Systems: Are Yours Fit for Purpose?

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-617-L04-P; CME 1.25; IACET 1.25; RN 1.25

Electronic systems play a critical role in the conduct of clinical trials, but when inadequately validated and maintained to ensure that they are fit for use for their intended purpose, they may significantly impact the quality and reliability of clinical trial data. In this session, we will discuss examples of electronic systems commonly used to conduct clinical trials and expectations for their validation and maintenance. Examples of frequently encountered issues impacting data quality will be presented and discussed. The role of quality assurance, in maintaining oversight of these systems will also be considered. Perspectives from regulators and regulated industry will be provided.

Learning Objectives

Discuss the importance of ensuring that electronic systems used to conduct clinical trials are adequately validated and fit for intended purpose; Describe how regulators evaluate electronic systems; Discuss the role of quality assurance in ensuring regulatory compliance of electronic systems used by their organizations.

Chair

Jean M. Mulinde, MD

Speaker

MHRA Perspective
Gail Francis

FDA Perspective
Cheryl Grandinetti, PharmD

Industry Perspective
Jonathan Raymond Andrus, MS



Speakers
avatar for Jonathan Andrus

Jonathan Andrus

Chief Business Officer, Clinical Ink
Jonathan is responsible in helping sponsors and CROs better leverage eSource, eCOA and ePRO. At Clinical Ink, he is responsible for P&L across products and services and he is also focused on building partnerships with customers. Mr. Andrus joined Clinical Ink from BioClinica where... Read More →
avatar for Gail Francis

Gail Francis

Expert Inspector, GCP, Medicines and Healthcare products Regulatory Agency (MHRA)
Gail Francis joined the MHRA in November 2003 as a GCP Inspector. Prior to joining the MHRA, Gail spent approximately 10 years in the Pharmaceutical industry. Her first role in the Pharmaceutical Industry was in Pharmacovigilance, before moving into Clinical Research and has held... Read More →
avatar for Cheryl Grandinetti

Cheryl Grandinetti

Health Scientist, Policy Analyst, OSI, OC, CDER, FDA
Dr. Grandinetti is a reviewer in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation /Office of Scientific Investigations in CDER/FDA. She provides regulatory and scientific oversight for CDER-assigned bioresearch monitoring activities and... Read More →
avatar for Jean Mulinde

Jean Mulinde

Medical Officer, Senior Policy Advisor, OSI, OC, CDER, FDA
Dr. Mulinde is currently the Senior Policy Advisor, Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products... Read More →


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session