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Tuesday, June 28 • 2:00pm - 3:15pm
#234: TransCelerate's Risk-Based Monitoring: Sharing What We Are Learning

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

TransCelerate members will share successful risk-based monitoring (RBM) implementation lessons learned during this interactive session. Regulators, sponsors, CROs and clinical research site personnel will gain practical insight for an RBM implementation strategy.

Learning Objectives

Discuss successful practices and lessons learned through an evaluation of TransCelerate company risk-based monitoring (RBM) studies and recent publications; Describe key change considerations needed to successfully implement an RBM strategy both from a site and sponsor perspective; Summarize what this unique collaboration of 20+ sponsors is doing to assist vendors in understanding the technology gaps with respect to existing tools and systems that support RBM methods.


Brett Wilson


TransCelerate RBM Successful Practices and Lessons Learned
Joanne Benedict, MSc

TransCelerate's Approach to Understanding and Managing Site and Other Stakeholder Expectations, Wants, and Needs
Kate Owen

Site Representative
Allison Camacho

Searching for a Technology Solution to Support Risk-Based Monitoring
Mary Cusack

avatar for Brett Wilson

Brett Wilson

Head, Monitoring Excellence, Bristol-Myers Squibb Company
Brett Wilson, BSP, is Head of Monitoring Excellence at Bristol-Myers Squibb and leads both Risk Based Monitoring and eSource initiatives with TransCelerate BioPharma. Within BMS, Brett is responsible for ensuring an accountable and sustainable adaptive monitoring model focused on... Read More →

avatar for Joanne Benedict

Joanne Benedict

Senior Advisor, Genentech, A Member of the Roche Group
Joanne Benedict is a Senior Advisor in Roche Genentech's Process, Training, and Systems group. She develops business strategies, processes, and systems which support continuous improvement and innovation in clinical trials. Specializing in operations, technology, and process optimization... Read More →

Allison Camacho

Research Manager, Dallas Diabetes and Endocrine Center
Allison Camacho joined Dr. Julio Rosenstock as his Research Manager of the Dallas Diabetes and Endocrine Center in 2002. Currently, Allison’s responsibilities include managing eight coordinators, five supporting staff, and manages the budgets and contracts for the site, ensuring... Read More →
avatar for Mary Cusack

Mary Cusack

Associate Director, Global Clinical Operations, Bristol-Myers Squibb Company
Mary has over 17 years of pharmaceutical experience of which over half have been spent at Bristol-Myers Squibb in Global Clinical Operations. Mary serves as the Business Integration Lead. In this capacity, she has responsibility to manage technical implementations within clinical... Read More →
avatar for Kate Owen

Kate Owen

Vice President, Clinical Trial Management, Novo Nordisk Inc.
Kate is the Vice President of Clinical Trial Management at Novo Nordisk (Princeton, NJ) with 22 years’ experience within the biotech, pharmaceutical and CRO space. Her leadership has led to improved productivity, cost-effectiveness, quality and staff morale. She sponsors the Novo... Read More →

Tuesday June 28, 2016 2:00pm - 3:15pm EDT
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Session