Here is an interview I recorded with Geoff Taylor, Director of Clinical Quality Assurance at Eisai Product Creation Systems.
Geoff will be giving the keynote presentation 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:
- The challenges around senior management buy-in to make the up-front investment in time and resources to move to a risk-adaptive approach
- The changing balance of activities between data managers, central monitors and field-based monitors
- The potential for the field-based monitor role to take a more active approach to site relationship management, and the possible shift in skills for the next generation of monitors
- 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 Geoff points out, there’s far more to risk-adaptive monitoring than simply cutting costs!
Other speakers at the conference will include:
- Miguel Valenzuela, Bayer (also interviewed for ClinDev)
- François Beckers, GSK Vaccines
- Patricia Eriksson, Sanofi Pasteur
- Natalia Zurita, Almirall
- Marc Buyse, IDDI & CluePoints
- Daniel Milikowski, AstraZeneca