By Steve Gens

In my last blog, I shared with you some of the findings from our recently completed 2018 World Class Regulatory Information Management; Connections to QMS, Supply Release, and Product Change Survey. In particular, I spoke about the progress made with RIM investments and how these are – or aren’t – impacting efficiency and data quality.

This time, I’d like to explore the value of having a dedicated RIM group and to what extent organizations are leveraging RIM functionalities across other parts of the organization.

For the first time in our surveys, we explored organisational strategies as they relate to performance and data quality levels. One area was having a dedicated RIM group, because several of our clients have been thinking about this or have implemented one. What surprised us was just how prevalent this has become, with 61% or 42 companies saying they have a dedicated RIM group. One of the questions that we would like to ask, given this finding, is what is the primary purpose of this group, or what are its three main activities?

What we found with those with a dedicated RIM group have higher efficiency levels and they achieved more business benefits when compared to those without this organizational strategy. There was a significant degree of global deployment of key regulatory capabilities (registration management, submission management, label compliance management, etc.) in 75% of their affiliates, meaning a dedicated RIM group is directly correlated to better global system deployment and performance. But what we were expecting to find and didn’t was a different in data quality levels, meaning there was no correlation in dedicated RIM groups or the affiliate reporting relationship to data quality levels, so our insight into data quality levels is that it is more a cultural or organisational mindset.

An important consideration with RIM is how it might positively impact other functional areas, which would require capability connections across key parts of the business. To that end, we asked survey participants their intentions with regards to functional connections. We further broke that down by asking about timing: did they intend to make near-term changes (2018 – 2020), were there plans for change after 2020, or were no changes planned?

The responses showed there is a lot of focus on near-term change, especially on clinical, product supply release, and product change control processes. Most organisations expect to improve cross-functional information flows to benefit full lifecycle management processes, which is where most of the compliance risk lies.

Perhaps most significant is 94% are trying or planning to improve the regulatory impact assessment (RIA) process within the next two years. That’s very dramatic and it speaks to the challenges companies face whenever there is a proposed product change. Some of the main improvement areas were better understanding the cost of the manufacturing change versus the cost of the assessment / health authority submissions, reducing the number of RIA, better leveraging RIM to facilitate the RIA process, and improving the reliability of country filing requirements.

Achieving better coordination with both supply release and the product change control process will require companies to connect their product registration systems to ERP, and currently only 11% have that connection. That’s expected to increase to 40% in two years, underscoring just how important enterprise connectivity has become to companies.

There is still much that can be done to improve and strengthen those connections and we will continue to explore that with companies. To what extent are you connecting your RIM capabilities across other functional areas? And what benefits have you realised from this?