Miguel Valenzuela discusses risk-adaptive monitoring

Here is an interview I recorded with Miguel Valenzuela, Head of Business Intelligence and Oversight at Bayer PLC.

Miguel will be presenting on risk-adaptive monitoring at a conference on Risk-Based Approaches to Clinical Trials, held in London on April 24-25, 2013. I am also pleased to confirm that the conference organisers have offered a 15% discount off the full delegate rate for all ClinDev readers. Simply use the code CQ4173ClinDev when registering.

We discuss a variety of topics, including:

  • Whether risk-adaptive monitoring is about more than cutting costs
  • How performance and quality metrics can facilitate better use of personnel
  • What regulators still need to do to help organisations to adopt the approach more quickly
  • How quickly risk-adaptive monitoring could be as ubiquitous as EDC is today

The conference will cover all of the key factors which must be taken into consideration when making the transition to a risk-based approach – with the aim of improving efficiency whilst remaining compliant and without impacting deliverables. It is estimated that sponsors can save 23% of trial costs with a risk-based approach… but as Miguel points out, there’s far more to risk-adaptive monitoring than simply cutting costs!

Other speakers at the conference will include:

  • Geoff Taylor, Eisai (also interviewed for ClinDev)
  • François Beckers, GSK Vaccines
  • Patricia Eriksson, Sanofi Pasteur
  • Natalia Zurita, Almirall
  • Marc Buyse, IDDI & CluePoints
  • Daniel Milikowski, AstraZeneca

2 thoughts on “Miguel Valenzuela discusses risk-adaptive monitoring

  1. Pingback: Geoff Taylor discusses risk-based approaches to study management & monitoring | ClinDev

  2. Pingback: FDA completes guidance on risk-based monitoring | ClinDev

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