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Monday, June 27 • 10:45am - 12:00pm
#124: Risk-Based Monitoring in Clinical Trials

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Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-518-L05-P; CME 1.25; IACET 1.25; RN 1.25

This symposium will examine the implementation of risk-based monitoring strategies in clinical trials and their impact on site performance, patient safety, data integrity, and study quality.

Learning Objectives

Discuss how risk-based monitoring (RBM) can help investigator sites improve overall site performance, with higher efficiency and improved patient safety; Describe best practices in site/CRO partnering to successfully drive efficiencies and improve oversight of patient safety and data quality; Identify the importance of planning the RBM strategy in order to make it actionable.

Chair

Ellen Kelso

Speaker

How to Successfully Plan and Implement a Risk-Based Monitoring Strategy
Francois Torche, MBA

Risk-Based Monitoring: What Does It Mean for Clinical Study Sites?
Jill Collins

The Impact of Risk-Based Monitoring on Site Performance: Reducing Risks While Improving Patient Safety and Study Quality
Robin Douglas, MA



Chair
avatar for Ellen Kelso

Ellen Kelso

Executive Director, Chesapeake IRB
Founder, managing member & CEO of Goodwyn IRB, Ellen Kelso is recognized for her experience & expertise in clin. trial mgt & reg. affairs. Has provided educ., consultation & services to the pharma industry supporting clinical research & regulatory strategies, submissions & compliance systems.

Speakers
avatar for Jill Collins

Jill Collins

Executive Director, Innovation, INC Research
Jill Collins, Executive Director, Clinical Innovation at INC Research, with 20 years of experience in global operations management, leads the development of transformative approaches to trials with a focus on data-driven process optimization, including INC’s RBM solution: Strategic Data Monitoring. She is an active member of the ACRO-Transcelerate CRO Forum on the Risk-Based Monitoring and the Shared Investigator Platform Working Groups. Jill... Read More →
RD

Robin Douglas

Site Solutions Director, Site and Patient Networks, Quintiles
Robin Douglas has 22 years of clinical research experience, including 16 years as a site manager / administrator. | | Currently Robin serves as Site Solutions Director at Quintiles. Her core responsibility is to ensure an enhanced site experience when working with Quintiles which includes leading our RBM Site Readiness team. Prior to that, she served as Director of Site Management and was responsible for the performance of the Prime and... Read More →
avatar for Francois Torche

Francois Torche

Chief Executive Officer, CluePoints
François holds a Master in Business Administration from the ICHEC School of Management, Brussels. Over the past 18 years in the pharmaceutical industry, he has held positions as statistical programmer, developer and IT project leader for companies such as GSK, UCB and IDDI. During his ten year tenure with IDDI as an IT Specialist, Mr. Torche assisted in the development of the CluePoints' statistical engine. Francois has served as CluePoints... Read More →


Monday June 27, 2016 10:45am - 12:00pm
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA