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Sunday, June 23 • 1:30pm - 5:00pm
SC34: #34: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model

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Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-19-513-L04-P; CME 3.25; IACET 3.25; RN 3.25

The current clinical trial climate demands that sponsors find ways to reduce clinical trial complexity, drug development costs, and get more value from R&D budgets. Risk-based monitoring (RBM) allows organizations to target site monitoring activities for which risks can be best managed and deliver the greatest benefit to the study, and to become more effective and efficient in using resources, while increasing quality and patient safety. Participating TransCelerate Member Companies came together in 2012 to establish a model approach to high-quality RBM. To date, this effort has published a position paper on risk based monitoring, as well as several articles focused on sharing advancements, best practices and lessons learned from member companies adoption experience, all of which are publicly available. This short course, will define core concepts and main principles of the methodology, share key tools and discuss their use, share experiences and lessons learned, and address important questions about RBM and its implementation. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for professionals involved with clinical and data operations.

Learning Objectives

At the conclusion of this short course, participants should be able to:
  • Define core concepts and main principles of the TransCelerate risk-based monitoring (RBM) methodology;
  • Discuss the use of key tools in the RBM process;
  • Identify common challenges with effective monitoring and discuss how they can be addressed through appropriate use of the RBM methodology.



Speakers
avatar for Barbara Suarez

Barbara Suarez

Director, Clinical Study Support, GlaxoSmithKline
Barbara A. Suarez, M.S., Director of Clinical Study Support for the US Local Operating Company at GlaxoSmithKline Pharmaceuticals. Over the course of 20 years within the industry, Barbara has served in diverse roles of increased responsibilities within Clinical Operations. Since 2013... Read More →
avatar for Rodrigo Perez

Rodrigo Perez

CSU Risk-Based Monitoring (RBM) Business Lead, Sanofi
Rodrigo Perez, based in Mexico City, has more than 12 years of experience in clinical research working for Sanofi’s Clinical Study Unit (CSU) in different roles (CRA, Study Manager, and Operations Manager, among others). Graduated from Universidad La Salle, Rodrigo has a bachelor’s... Read More →


Sunday June 23, 2019 1:30pm - 5:00pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA