Over the past year, many companies and individuals have increasingly inquired about the company’s research. So I have decided to start this blog to keep you casually updated on our latest findings and survey news on a monthly basis.
We have been doing industry benchmarks since 2007 which have greatly grown in size and scope. The past three years have been spent focusing on the changing Regulatory Information Management (RIM) environment with over 55 unique companies participating, finding value in the research and how they compare to their peers.
In this first blog I’m planning to stick to several salient points from our recent RIM research, but please refer to the detailed study findings whitepaper and other public presentations on the website.
This recent RIM study consisted of 41 companies, 45% European based, 40% US and 15% based in Japan. 33 out of the largest 50 biopharmaceuticals participated, along with 8 smaller companies (>$300 million in revenue).
The first point, which came as no surprise, revealed RIM is growing in strategic importance as many core functions rely on this regulatory information, such as manufacturing, supply, and clinical. It truly is a corporate asset. The movement is gaining much more attention from the executive suite as there is a significant push to increase business efficiency and productivity in addition to the traditional regulatory compliance goal. RIM is a means to evolve the organization and make it more efficient. The overall efficiency rating for most participating companies was low due to disconnected information sources and significant data quality challenges.
The next point was just how far RIM programs are being adopted geographically. The globe is becoming very small due to global collaboration that requires daily sharing of information and exchanging with many 3rd parties. The most typical RIM capabilities extended to the local affiliate were registration and commitment management, R&D document management, label tracking, and health authority correspondence management.
The next headline was that dossier outsourcing is no longer a growing trend, rather a common practice as 80% of industry is outsourcing some part of their submission volume compared to just 43% of companies in 2008.
Finally, we noticed a growing challenge in late 2013 and started speaking with our clients, solution providers and in public speaking forums regarding a growing innovation gap: the pace of industry change is greater than the solution provider’s ability to innovate and this has become an industry challenge. We tested this out in last year’s research with an innovation ranking of 19 providers with only one having high innovation marks.
Now, doing the survey is great, but the thing we really enjoy is the opportunity to debrief participating companies to learn their views and often we do follow-up analysis based on their questions and observations. A common question was directed at our peer ranking: “what makes the top 7 companies so special compared to the other 34?” Our ranking was driven by a combination of efficiency rating and their RIM capability foundation rating. The follow-up analysis revealed some points that we expected while there were some surprises and interesting learning points.
The thing we actually found very surprising was the lack of evidence supporting our hypothesis that highly rated companies would have a simple product portfolio and a limited geographic scope (number of affiliate offices). This assumption was not the reality. In actuality, these companies tend to have a high amount of products (Active Registrations) and typically had over 100 local affiliate offices. Due to this analysis, we now believe they’ve made many pro-active investments to reduce the complexity of operating in their global environment as a business necessity.
We expected these top 7 companies to be highly focused on productivity and efficiency which was very true, however their programs were also highly cross-functional and their solutions were used by more than 75% of their affiliate offices. So this was really substantial.
The other thing we were curious about was any correlation between high performance and certain RIM solution provider tools. Were there more off the shelf or custom solutions? We found no pattern to certain solution providers and a split between off the shelf and custom solutions.
So that’s it for now! I just wanted to give you some highlights from what we’ve learned from our last survey. There is much more to come as we recently completed a “Next Generation Content Management” industry survey including interviews with 9 solution providers. We also calculated the anticipated spend of IDMP compliance for the top 250 biopharmaceuticals at an estimated $405 million; stay tuned for those details. We’ll see you again in mid October!
