RIM Survey in Full Swing as We Explore Changing Regulatory Environment More Deeply

We’re in the midst of enrolling and developing our 23rd industry survey, which follows up from a comprehensive regulatory information management (RIM) survey my colleagues and I at Gens and Associates conducted 18 months ago. Indications are that this will be a big hit, though at this stage just how big the response will be is difficult to quantify.

While past surveys have tended to focus on the Top 70 pharma companies, we have in collaboration with ProductLife Group, extended this year’s survey to smaller organisations – those outside of the top 70 — in order to get a better sense of what’s happening with smaller companies. As in the past, this is a global survey with solid representation from all regions and countries.

We initiated the survey by inviting 10 companies to participate in the survey’s design during two sessions, one of which was held in Germany and the other in the United States. Those companies provided critical input into the final survey design. One noteworthy observation is that these companies encouraged us to debrief the health authorities on our findings once the survey has been completed.

Our last RIM survey generated so much interest from pharma companies and providers that we decided to explore several topics more deeply for a few reasons. The fact is that more and more companies are looking at their current RIM strategies and are conducting major overhauls or initiating large-scale investments. Integral to that strategy is the desire to solve the whole local, regional, and global capability conundrum most have struggled with. Adding to that challenge is the fact that so many parts of the business outside of regulatory use regulatory information, and so it is an enterprise asset.

We also wanted to explore the vendors on the software and services side more closely, and quantify from an industry perspective who is innovating and who is not. Another big topic in this latest survey is regulatory intelligence, which we believe is an up-and-coming trend, and therefore warranting more extensive investigation.

So over the next couple of months we’ll be delving deeply into seven sections: 1) RIM programs; 2) collaboration and the affiliate network; 3) regulatory intelligence; 4) regulatory information architecture and governance; 5) RIM and the cloud; 6) regulatory/safety outsourcing trends; and 7) vendor and implementation landscape and satisfaction levels.

Once the enrolment stage is complete, we’ll move into the research analysis and result generation phase. We anticipate closing the survey in mid-September, with results being made available by the end of September.