The maturing of RBM implementation

RBM is become widely accepted a key practice in ensuring clinical trial data quality and patient safety. This blog discusses the observed growth in maturity of the industry as we see companies progressing from risk detection and data visualisation to implementation and training being a more pressing need.

 

As we at TRI continue to engage with industry on RBM implementation, I am pleased with the observations that we are currently making across a range of CRO and Pharma companies. Rolling back the clock 18-24 months and most of the discussions we were having with customers and prospects were about risk detection, data visualisation and stats models.

For the sake of this article, I will take a very high level approach to RBM implementation, and break it into three core phases:

  1. Approach and planning
  2. Risk detection and management
  3. Training and operational implementation

Initially, our observations were that the focus was more relevant to the early part of phase 2, rather than the more logical starting point of phase 1. This is not atypical for our industry  – we do have a tendency to jump on technology as the starting point of a project, rather than sitting down and thinking through the challenge, opportunity and approach in a methodical way.

I suspect there are a few human forces at work here – the first is that thinking is much harder than listening. It’s much easier to have vendors come in and talk about RBM and their technologies than it is to decide what you need and then identify appropriate technologies. It is also a very immature market – awareness levels are low and so a lot of companies still don’t actually know what is out there and what their options are, so don’t dare dream too big in case there is nothing out there that could support their needs. Thirdly, meeting with vendors, looking at technologies and potentially implementing software is all about action – it’s visible and we get rewarded for action. Thinking and planning are less visible, more cerebral processes and less likely to get noticed and or rewarded.

Many companies are still at phase 1 of the RBM journey and quite expectedly so – RBM is still a relatively new opportunity in our industry. Many are now thinking about phase 2, but have also seemingly put more time and energy into phase 1 as a prelude to those activities. The really exciting observation however, and the point of this blog is that we are now truly seeing companies grappling with what we see as the biggest challenge of all – taking the approach and the technology and delivering something of true value to that company, to the patients involved in the trials and to industry as a whole. The considerations of roles, new roles, impacts on existing roles, data, what data, where, ownership, quality, change, training and so on are where the industry leaders are now starting to spend their time. The fact that we are getting to this point after just a few years should be encouraging to the rest of the industry and shows that real progress is being made.

At TRI we are focusing on ensuring not only that our RBM platform, OPRA delivers the best solution in risk detection and management, but also that we are able to guide our customers through the implementation and embedding process whether or not they are using our platform. We will be posting more information over the coming months about implementation and publishing case studies to share our successes and learnings.

In the mean time for more information about our RBM implementation services please see our website at www.tritrials.com/professional-services/

 

Thank you.