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Tuesday, June 26 • 2:00pm - 3:15pm
#262: The Risk Assessment Is Done: Now What? A Guide to Setting Up a Centralized Monitoring Plan

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-597-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session shares how group of sponsors, CROs,and RBM/data analytic vendors have explored centralized monitoring data/metric use and describes a centralized monitoring plan template that supports implementation of centralized monitoring.

Learning Objectives

Explain how centralized monitoring supports the quality management approach of ICH E6 (R2); Describe some key items to consider as you develop your centralized monitoring plan.

Chair

Linda B. Sullivan, MBA

Speaker

Sponsor Perspective
Nurcan Coskun

RBM Data Analytic Vendor Perspective
Keith Dorricott

CRO Perspective
Olgica Klindworth


Speakers
avatar for Nurcan Coskun

Nurcan Coskun

Global Risk Based Monitoring Program and Technology Solutions Manager / MC2, Medtronic International Trading Sàrl
20 years of clinical research experience with contributing in roles such as Clinical Research Manager , Global Clinical Operations Oncology Group Leader, Project Leader, Clinical Monitoring Manager and recently as Global Risk Based Monitoring and Technology Solutions Manager. Her... Read More →
avatar for Keith Dorricott

Keith Dorricott

MCC Ambassador; Director, Dorricott Metrics and Process Improvement Ltd.
Keith Dorricott is Director, Dorricott MPI Ltd. and a Ambassador for the Metrics Champion Consortium. He has a background in manufacturing from Kodak Ltd. He has worked in quality, metrics, process improvement and operational roles over 11 years for two major CROs. He is a Master... Read More →
avatar for Olgica Klindworth

Olgica Klindworth

Associate Director, Data Analytics, PPD, Inc.
Ms. Klindworth is the AD, Data Analytics at PPD, Inc. She has over 14 years of experience in the clinical research, mostly in data management. Olgica joined PPD's Data Analytics group in 2014, and since then helped build the cross-functional team, implement analytical and centralized... 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 →

Tuesday June 26, 2018 2:00pm - 3:15pm EDT
Room 205C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  08: R and D Quality-Compliance, Session