Remote Monitoring of Clinical Trial Sites

Remote Monitoring of Clinical Trial Sites - Webinar CD/Transcript

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Remote Monitoring of Clinical Trial Sites: Strategies for Quality Control and Cost Savings

It costs $4,500-$5,000 per day to monitor a clinical trial in person. Remote electronic monitoring can cut that cost to near zero. To cut your clinical trial costs in a big way, please read on ...

Hoffman LaRoche/Genentech veteran Ken Schiff demonstrates how to use quality risk management principles, electronic data capture (EDC) and other IT systems to monitor clinical trial sites remotely, feeding data into a “dashboard” that alerts you when things go awry. The alerts can be as simple as green, yellow and red lights.

Sound simple? Well, it’s not really — there’s much you need to know. Plan on a fast-paced session covering:

  • Identifying critical-to-quality (CTQ) metrics/key risk indicators and associated risks you deem worth tracking
  • Tips for identifying clinical sites that are best suited as pilot locations for remote monitoring
  • Building a dashboard that can monitor thousands of trial sites worldwide
  • How to sell remote site monitoring — capital investment and expected cost savings — to senior management
  • The 7 FDA and EU regulations and guidances that form the foundation for clinical quality risk management
  • Understanding the FDA’s and EMA’s definitions of clinical trial quality to ensure your monitoring system captures these elements
  • 16 key steps to implement quality risk management into your clinical trials
  • And much more…

Speaker Ken Schiff has pioneered dashboard creation at Hoffmann LaRoche/Genentech as head of QA and quality risk management. He’ll walk you through the complexities — always in plain English, of course.

Now that the ICH Q9 Quality Risk Management (QRM) guideline has become an accepted standard for FDA-regulated drug, device and biologics manufacturers, figuring out how to meet compliance standards while controlling costs is more important than ever. On-site monitoring can cost $4,500-$5,000/day. Cut just 20% of this cost and you can easily save $10 million per clinical trial. Discover the tools you need and how to put them in place.

  • Clinical trial managers
  • Clinical trial monitors
  • Clinical trial study coordinators
  • Clinical investigators
  • Clinical quality assurance professionals
  • Regulatory affairs and compliance professionals
  • Clinical research professionals
  • Clinical operations professionals
  • Medical affairs professionals

Ken Schiff is the president and owner of Quality Risk Management Associates, LLC, a consulting firm which specializes in providing risk management support to pharmaceutical and biotechnology companies around the world. With broad expertise in all phases of pharmaceutical development- from R&D through distribution and associated regulations focused on GxP, Quality Risk Management Associates ensures regulatory compliance and minimizes risk across the clinical development process. Prior to this, Ken joined Hoffmann LaRoche/Genentech in 2006 as the Head of Quality Assurance and Quality Risk Management. He was responsible for overseeing quality assurance support and applying quality risk management concepts in the conduct of clinical trials.