FDAnews Announces — Using Risk-Based Clinical Trials Monitoring to Lower Data Errors Webinar, Nov. 30, 2016

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Is risk-based monitoring the way to go for the next clinical trial? Join Alan Frederickson and Crona O’Conallain, both of QuintilesIMS, on Nov. 30 when they’ll share recent research showing how RBM can increase study quality and patient safety.

Using Risk-Based Clinical Trials Monitoring to Lower Data Errors
**An FDAnews Webinar**
Nov. 30, 2016 — 11:00 a.m. – 12:30 p.m. ET
http://www.fdanews.com/risk-basedctmonitoring    

Is risk-based monitoring the way to go for the next trial?

These statistics may help:

  •     4x lower errorrate in critical data in a head to head comparison of RBM to traditional 100% SDV in 2015
  •     45% reduction in the number of missing pages in RBM studies vs. traditional studies in 2015
  •     47% higher Action Item closure on RBM vs. non-RBM in 2015
  •     5x as many RBM study sites enter data within 7 days vs. traditional study sites (46% vs 8%) in 2015
  •     Up to 25% savings

Join Alan Frederickson and Crona O’Conallain — both of QuintilesIMS — on Nov. 30 when they’ll share recent research showing how RBM can increase study quality and patient safety.

By attending this 90-minute webinar attendees will find out how to design and implement a risk-based clinical trial monitoring program, starting with key concepts including:

  •     The latest insights of how RBM is transforming clinical development
  •     Understanding the challenges to overcome while implementing an RBM approach
  •     The technology to implement centralized monitoring
  •     Why the distribution of data across study sites might trigger an alarm
  •     Key metrics that can point to poor performance and noncompliance

This session will give attendees a roadmap for establishing a risk-based monitoring plan that can help prevent data "surprises" in monitoring that could be revealed during an inspection … 2) help manufacturers be fully compliant … and 3) satisfy the FDA.

Meet the Presenters:
Alan Frederickson, Senior Director, Technology & Automation Solutions, Data Sciences, Safety & Regulatory, QuintilesIMS

As Sr. Director, Technology and Automation Solutions for Quintiles, Alan focuses on enhancing the quality and efficiency of technology solutions to support Risk-based Monitoring, Clinical Data Management, Biostatistics, Medical Writing, Regulatory and Pharmacovigilance, with workflow management and data accessibility, aggregation and analytics.

Crona O'Conallain, Senior Director Data Sciences, Safety and Reporting at QuintilesIMS

Crona O’Conallain holds a B.Sc. and Ph.D. in Biochemistry from University College Dublin (UCD). Crona has held numerous leadership positions with her 14 years in the QuintilesIMS Global Data Management organization, and is now on the QuintilesIMS’s leadership team for Risk Based Monitoring, leveraging her Data Management experience in supporting the development of a Centralized Data and Operational Surveillance (CDOS) organization that drives the RBM model.

Who Will Benefit:

  •     Medical Affairs Officers
  •     Director of Clinical Operations
  •     Regulatory Affairs Professionals
  •     Director of Publications
  •     Director of Clinical Trial Regulatory Management
  •     Clinical Trial Information Disclosure Directors
  •     Global Clinical Safety and Pharmacovigilance Officers

Webinar Details:
Using Risk-Based Clinical Trials Monitoring to Lower Data Errors
**An FDAnews Webinar**
Nov. 30, 2016 — 11:00 a.m. – 12:30 p.m. ET
http://www.fdanews.com/risk-basedctmonitoring    

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/risk-basedctmonitoring                            
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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