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Sunday, June 26 • 1:00pm - 4:30pm
#37: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model

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Limited Capacity seats available

Component Type: Tutorial
CE: CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

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 RBM, 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 tutorial, hosted by TransCelerate BioPharma, Inc., 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.

Who should attend?

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

Learning Objectives

• 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 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, she is also experienced with change management including training programs which maximize embedding of new business processes.
avatar for Lisa Horne-Lucero

Lisa Horne-Lucero

Consultant, RBM Operations, Clinical Risk Management, Eli Lilly and Company
Lisa is an RBM Operations Consultant in Eli Lilly’s Clinical Risk Management organization. She develops and implements RBM processes, procedures and training as she guides study teams through the RBM implementation process. She has been a key leader in the implementation of RBM at Lilly since its inception. She also continues to serve as a site monitoring subject matter expert for the business.


Sunday June 26, 2016 1:00pm - 4:30pm
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA