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Monday, June 15 • 1:30pm - 2:30pm
#119 L: How Do You Oversee and Manage New Centralized/Remote/Site Monitoring Models? What Should you Measure to Gain Insights?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-595-L04-P; CME 1.00; IACET 1.00; RN 1.00

An industry consortium has been developing a set of metrics to measure the process of centralized and site monitoring. The forum will provide insights into the approach, the progress, and plans to obtain further industry feedback.

Learning Objectives

Describe methodologies for developing metrics to monitor the processes related to centralized, remote and site monitoring; Discuss some of the challenges of developing metrics to monitor risk-based processes.

Chair

Linda B. Sullivan, MBA

Speaker

Panelist
Charles Lawrence Liss, MS

Panelist
Barbara Alexandra Novak

Panelist
Joe Kunakorn, MS

Panelist
Jacqueline Gough, MS



Speakers
avatar for Linda Sullivan

Linda Sullivan

Executive Director, Metrics Champion Consortium
Ms. Sullivan is the Co-Founder & Executive Director of the Metrics Champion Consortium (MCC), an industry association dedicated to leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. She has... Read More →
avatar for Barbara Novak

Barbara Novak

Systems and Process Management Lead, Clinical Operations- NA/EU, Kyowa Kirin Pharmaceutical Development, Inc.
Barbara Novak – Systems and Process Management Lead, Clinical Operations KYOWA KIRIN PHARMACEUTICAL DEVELOPMENT Barbara has twenty five plus years of Clinical Research and Development experience and has worked at Kyowa Kirin for the past ten years. In her role, she is the North... Read More →
avatar for Charles Liss

Charles Liss

Associate Director, Global Biostatistics, CSL Behring
Mr. Liss has a MS degree in Statistics from Virginia Tech and nearly 40 years of experience in the pharmaceutical industry as a biostatistician. He has worked in a broad range of therapeutic areas including neuroscience, vaccines and cardiovascular. His research interests include... Read More →
avatar for Joe Kunakorn

Joe Kunakorn

Associate Director, Oncology Risk Management, Janssen Research & Development, LLC
Joe has 20+ years of experience in the Biopharma industry as a quality professional with expertise in auditing, QMS, GCPs, GMPs, and medical devices. In his current role with Janssen Research & Development, LLC, Joe leads the clinical quality oversight, risk management, and inspection... Read More →
JG

Jacqueline Gough

Director, Central Monitoring and Data Surveillance, Astellas
Jackie Gough is the Director for Central Monitoring and Data Surveillance at Astellas. Previously she led the RBM team at Lilly. Jackie began her career as a statistician – first in the academic world, then at a CRO and for the last 17 years on the sponsor side. She has been a member... Read More →
avatar for Linda Sullivan

Linda Sullivan

Executive Director, WCG Metrics Champion Consortium
Ms. Sullivan is the Co-Founder & Executive Director of the Metrics Champion Consortium (MCC), an industry association dedicated to leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. She has... Read More →


Monday June 15, 2020 1:30pm - 2:30pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Forum