Regulatory information management (RIM) is becoming more of a strategic asset with significant focus and priority surrounding regulatory operational efficiency and health authority interaction effectiveness are strong themes emerging from our first look at this year’s survey data.
As responses keep rolling in, we’ve decided to keep entries open for a wave two. So far, we have received 35 surveys with another couple likely to be submitted in the next few days. By the time we close entries down on 31 October, we expect to have around 45 respondents.
The number of responses we’ve had and expect to receive provides us with very rich data, so the results will be very meaningful for industry. On top of that, we’re getting data from across industry tiers. Typically, our past surveys have included data from large and mid-tier companies so we have a good handle on what’s happening at multi-nationals and those mid-tier companies. But this time we’re also getting responses from the small, fast growing mid-tier companies, which gives us better insight into the trends impacting those companies.
Reading the Data
At this stage the data are starting to settle and my colleague Greg Brolund and I are starting our analysis, and already there are some very strong trends emerging. Among these are:
- More than 60% of respondents see regulatory information management (RIM) being a strategic rather than simply operational necessity with 55% leveraging RIM capabilities regardless of division (pharma, biologics, medical device, consumer, vaccines, generics etc.)
- So far 85% consider improving health authority interaction to be a priority, meaning the correspondence, the questions process, commitment management and so forth
- Dossier outsourcing continues to grow with 85% now doing this at some level, up for 78% in 2013. There is an increased focus on outsourcing the daily maintenance and affiliate marketing submissions.
As we’re still receiving surveys, those figures will likely shift a bit, but not by much, which show the trend on RIM and outsourcing continues to grow.
With regards to the more strategic focus on RIM, generally companies cite compliance as a major reason to improve their RIM processes. But a clear theme to emerge in this survey is that companies are placing a priority on process efficiency improvement over next two to three years and are starting to plan accordingly. Two key areas where companies are eager to improve their efficiencies are: 1) globalising regulatory processes to improve the information flow between central and regional offices, in other words the affiliate network; and 2) improvement with manufacturing for change control and product release.
Finding Innovation
One question we posed this year centred on pharma companies’ perceptions about who is innovating and who is not among the regulatory solutions providers. The findings were quite surprising, with a couple scoring highly in innovation, the majority seen as not moving one way or another, but a few on a rapid decline.
Once wave two of the survey closes, at the end of October, we’ll start to debrief participants, between November 2014 and February 2015. For now, there is still time to participate so if your company wants to participate or you’re not sure whether your company has done so, please reach out to me, Steve Gens, at sgens@gens-associates.com or Adam Sherlock from ProductLife Group at asherlock@productlife-group.com