Me and my colleagues (Greg Brolund from Chicopee Falls Consulting and Sarah Powell from Powell Regulatory Services) write an annual white paper to provide a clear industry status of Regulatory Information Management (RIM) highlighting the current state, key trends and priorities, investment focus, projected capability and organization change, and a comprehensive update on the provider landscape. This year we have an exciting addition that focuses on defining and measuring World Class RIM.
This world class journey started in 2014 where a top rated company from our 2014 RIM survey was disappointed in their peer ranking as they rightfully believed there was a tremendous amount of work to be completed and value to be realized. We reflected on this and quickly determined that having just a peer ranking without a target or “gold standard” to achieve would never give a true industry status. We went to work with the help of 18 companies in four design sessions in the fall of 2015 to define the first world class RIM baseline. This entailed detailed discussions and debate of “what is world class RIM?” and more importantly “how do you measure it?”.
The theme from this research is plain and simple: we are in a period of unprecedented regulatory transformation and this will continue until at least 2020. Salient points from this year’s research include:
- 86% of companies are transforming some part of their RIM program
- Companies with a Common RIM Model are 3.5 times more likely to realize business benefits, 18% more efficient and have 2.5 times more confidence in data quality levels
- 85% of companies are projecting to realize key business benefits within the next 2 – 3 year
- Emerging technologies are beginning to be used to create an end to end regulatory view
- We will see a significant software provider market shift in the next three years
The information and graphs in this paper are primarily based on the results of our 2016 World Class RIM Study (54 companies), coupled with key learnings from participant debrief sessions, client work and our professional insights. The following series of blogs are based on the Annual RIM Whitepaper 2016 Summer Edition. I will structure them in 4 parts:
- Part 1: What is World Class RIM?
- Part 2: Comparing RIM Operating Models
- Part 3: Applying Emerging Technologies in the RIM space
- Part 4: Authoritative Source and Data Standards Update (IDMP/UDI/MDM)
Part 1: What is World Class RIM?
During the summer of 2015, we created a viewpoint of world class RIM and drafted the 2016 Survey in preparation for a series of design sessions with industry. We took great care to bring diversity into these sessions so different facets of industry were represented. We invited large multi-nationals, mid-tier and smaller organizations from each major region of the globe. We also wanted a good mix of product types inclusive of bio-pharmaceuticals, medical device, generics, and consumer. Many of these companies sent business and information technology (IT) representatives for the “grand debate”. Our travels took us to Chicago, London, New Jersey and one virtual session that brought many of the western United States companies together.
The debate and feedback was invaluable and we further tested several assumptions with other industry thought leaders. This resulted in our ability to create a survey that provides a precise measurement of a company’s status relative to this new world class target and will allow our algorithm to be utilized as a diagnostic tool. This allows companies to “retake” a subset of the survey in coming years to understand their progress or, for newly participating companies, to get an accurate measure of their current state relative to this new standard.
World Class RIM – Five Elements, Eight Questions
We created an overarching model (see Exhibit 7) to drive the thinking and approach to the following eight questions in the 2016 survey (49 questions in all) as a means of measuring current state.
- Efficiency Rating – Utilizing a four-point scale (very efficient, efficient, not efficient, very inefficient), participants rated their efficiency status for the 17 RIM capabilities (see appendix) The rationale for the scale is to ensure companies make a clear choice; are you leaning towards efficiency or inefficiency!
- Business Benefit Status – We had 12 categories of benefit realization with the rating scale being: 1) achieved benefit, 2) target by 2 years, and 3) not a priority.
- Metric Measurement Confidence – It is one thing to create a measure, but another to have confidence in the data you collect. Those embarking on a metrics program realize this is a learning process and it may take several iterations to get it right so the data can be reliable for continuous improvement. Our scale for 13 benefit categories was 1) Yes, with confidence, 2) Yes, with low confidence, 3) No, planning within 12 months, and 4) No, not planned.
- Metric Milestone Status – We asked: “Do you measure the time and have an approved standard milestone?” for 8 common regulatory activities (e.g. Core Dossier to local HA submission, HA question to response submission, label change approval to release to market). The scale was 1) Yes, measure with standard milestone, 2) Yes, measure with no standard milestone, 3) Standard milestone, but no formal measure, 4) Future priority, or 5) Not applicable.
- Operating Cost Understanding – Leaders and Managers understand their budgets and often portions of their compensation are tied to this fiduciary responsibility. Historically, most organizations are excellent in budget management, however in our opinion, have too little understanding of the long term total cost of ownership that is driven by the annual run rate and operating cost. This point applies mainly to the central groups. The economic understanding at the regional and local affiliate level is often unknown or greatly underestimated. In our view for world class RIM, it is necessary to understand the RIM run rate and 5-year total cost of ownership. Participants were asked to indicate their level of understanding of their current RIM run rate at both the central and local affiliate level.
- Time to Provide Accurate Reporting to Common Regulatory Questions – This is a very telling question and the survey results supported our underlying research hypothesis: “There a clear correlation between the time to report critical regulatory information and data quality confidence level and process/system efficiency”. We asked participants how long it takes to report regulatory information in six categories using the following scale: 1) hours, 2) days, 3) 1 – 2 weeks, or 4) greater than 2 weeks.
- Status of Global System Deployment to Affiliates – World Class means the “world” can access and utilize the core RIM capabilities with minimal use (it never goes away) of spreadsheets and SharePoint at the local affiliate, regional level, and headquarters (global teams). While it would be rare for a true 100% global deployment, we accounted for the agent/distributor network by requiring the RIM capability be deployed to greater than 75% of the affiliate offices. We asked participants to indicate their status of 10 common RIM capabilities using the following scale: 1) In affiliate, 2) Planning on extending to the affiliate within 2 years, 3) No plans to extend or 4) No authoritative source currently.
- Authoritative Source Data Quality Levels - It’s one thing to have an authoritative source for regulatory information, but what is the confidence level of the data quality? A company might in fact have good data quality, but if there is a perception of poor data quality, you have a “confidence” challenge. We asked participants to rate the status of 10 authoritative sources by the degree of confidence (high, medium, low) with other options being a) create an authoritative source within 2 years or b) does not apply to our situation.
RIM software vendors have talked about the importance of having a common platform or suite of products for successful management of regulatory information for years. In my next blog post, we will compare RIM operating models.