Deerfield, USA

Olly Olly Oxen-free! Utilising Risk-based Monitoring to More Effectively Identify and Mitigate Risk While Ensuring Patient Safety, Data Quality and Integrity


The PHUSE Deerfield Single Day Event was held at Advanced Clinical on July 21, 2016. The theme was risk-based monitoring (RBM). The day started with a keynote address and overview of RBM by Cheryle Evans of Advanced Clinical.

All of the presentations focused on how we can more effectively identify and mitigate risk while ensuring patient safety, data quality and integrity. The presentations were all of high quality and provided a variety of perspectives on RBM. The day ended with a lively panel discussion.



Advanced Clinical – Welcome & Keynote

Overview of Risk-based Monitoring and a Case Study of Implementation within a Mid-size CRO
- Cheryle Evans, Advanced Clinical

Operationalising Key Risk Indicators
Katie Obermeyer, Advanced Clinical 

Visual Analytical Tool - Patricia Wozniak, Advanced Clinical

Centralised Statistical Monitoring to Detect Data Integrity Issues - Alun Bedding, AstraZeneca

How Can I Contribute to Risk-based Monitoring? A Statistical Programmers Perspective
- Parag Shiralkar, Eliassen Group

PHUSE Update - Chris Hurley, MMS Holdings

Fraud Detection and Runway for RBM- Martin King & Naveen Katta, AbbVie

Update on Risk-based Site Selection Tool - Susan Thompson, FDA

The Role of Programmers in Defining and Execution of Trial Specific Reports as Part of Trial Set Up and Execution
- Sina Djali, Janssen R&D

Strategies for Managing Your Data to Support RBM Workflow - Casey Higgins, Chiltern

Runaway for RBM - Nareen Katta, AbbVie

Download the event brochure.

SDE Chairs:

Patricia Wozniak, Advanced Clinical

Edwin Fung, Advanced Clinical



Photo from the Day:



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