Duncan Hall

Articles

RBM Toolkit: Top 10 Core Key Risk Indicators

Five months have flashed past since the CBI's Risk-based Monitoring event, and so I was looking forward to observing how much the industry has moved on. At March's Clintech event in Boston, a dedicated RBM work stream gave me the opportunity to find out. 

 I cited 2014 as a year of learning and development, and it is shaping up to be exactly that. We are now seeing companies starting to define how they are going to approach the challenges and opportunities RBM presents.
  
  Having spoken to most of the sponsor and CRO companies at the event I observed that two strong trends are emerging—those companies who are defining their philosophy / approach to RBM and those  who are starting with the technology route. So this raises the age old question—should approach inform technology, or technology inform approach?
  
  My advice is definitely to focus on approach first. The reason for this is simple. If you are going to use data to inform decision making, the model you use must support your organization's belief system. If it doesn't, the organization won't act upon the data, because its beliefs will say otherwise.
  
  Think of the fuel gauge in your car—you are at liberty to accept that as an indicator of whether you are about to run out of fuel or not, but if you don't accept it, you better decide upon a different way of measuring the fuel level yourself. Either approach is fine, but what is not fine, is to agree that you'll go by what the fuel gauge tells you, and then ignore it when it goes into the red. It is just the same with risk indicators—agree how you want to measure risk, and then be sure to act. Once you know how you want to measure risk, and how you will act when a risk is identified, you can select the most appropriate technology to support that model.
  
  How are you approaching the RBM journey? I’d love to hear from you and share some experiences.
  
  Duncan Hall can be contacted at 

Five months have flashed past since the CBI's risk-based monitoring event, and so I was looking forward to observing how much the industry has moved on.

RBM Approaches Taking Shape

Risk-Based Monitoring – Beyond Theory In-Depth Review

Validation - a word we use a lot in this industry. For Triumph Consultancy Services, it is usually a term which we associate with systems development, but on this occasion I'm excited to say I'm talking about validation of our new business division and its ideas. This week I was privileged to present at the CBI's Risk-Based Monitoring event in Philadelphia. For the first time since its incorporation, I was presenting as the CEO of Triumph Research Intelligence - a division of Triumph set up with the specific purpose of bringing the best possible Risk-Based Monitoring approach, software platform and services to the life sciences industry. 
  
  Having just released our 

 earlier this week the presentation was a key opportunity to present some of the core messages from that paper to some of the industry’s most forward thinking business leaders. The response was beyond even my most optimistic of expectations. Questions at the end of the presentation ranged from wanting further insight into the statistical methods we employ, the technologies behind the data extraction and transformation from source systems into our quality risk engine, to more company specific needs - how can we integrate this with our existing data capture infrastructure, and how can we use this as a platform for both risk detection and performance management with our own metrics and measurements? All great questions, and all a good indication that RBM is really now at the forefront of most clinical R&D team's agendas. 
  
  2013 has been a year of RBM information gathering for the industry and it looks like 2014 is going to be a year of action, learning and further development. There is anticipation and excitement abounding right now, and I think we all realise that RBM is a genuine opportunity to solve some of the quality and cost challenges that are so prevalent in the industry today. Triumph Research Intelligence are well positioned to support the industry on that journey and will continue to invest heavily in our software platform and supporting services to ensure we can support our clients and the industry as a whole to the best of our abilities. 
  
  So what did validation mean for us this week? A queue of people waiting for me as I left the podium that day, and beyond that, a further queue of people waiting to talk to us at our exhibition stand. Validation - it feels good to use the term in such a positive light!

Triumph's RBM position paper can be downloaded at 

Validation - a word we use a lot in this industry. For Triumph Consultancy Services, it is usually a term which we associate with systems development, but on this occasion I'm excited to say I'm talking about validation of our new business division and its ideas.

Duncan Hall

Articles

RBM Toolkit: Top 10 Core Key Risk Indicators

RBM Approaches Taking Shape

Triumph's Recap of CBI's Risk-Based Monitoring 2013