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