Remarque Systems

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The term “risk-based monitoring” (or RBM) has been widely used throughout the pharmaceutical industry, but what it really means and how it is implemented is the source of much debate. In this webcast, we’ll address five common myths of RBM and show how a quality management-based approach can set your clinical trial up for success:

  1. RBM is a new requirement of the ICH GCP guidelines
  2. RBM is just reduced source document verification (SDV)
  3. Technology alone can solve RBM
  4. Machine learning RBM solutions are costly and complicated to implement
  5. RBM cuts clinical investigators out of the loop

The objective of this webcast is to demonstrate that RBM is more than just SDV and remote monitoring. To fully implement RBM, one needs trained people, a robust process, and an integrated technology platform for quality management at every level of the study. Once fully implemented, RBM will reduce cost, improve data quality, and enhance patient safety.

Key Learning Objectives:

  • Why RBM is more than just source document verification and remote monitoring
  • What you need to fully implement RBM, including trained people, a robust process, and an integrated technology platform for quality management at every level
  • How full implementation of RBM will reduce cost, improve data quality, and enhance patient safety

Date:  Thursday, June 28, 2018

Time:  11am EST (NA) / 4pm GMT (UK) / 5pm CET (EU-Central)

Duration:  60 minutes

Featured Speaker:

  • Michael P. Arlotto, Ph.D, Founder, Remarque Systems

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