Are RIM Investments making a Difference? Understanding 2018 Survey Findings
By Steve Gens
We recently completed our 2018 World Class Regulatory Information Management; Connections to QMS, Supply Release, and Product Change Survey in April of this year. This was our 33rd benchmark and fourth focus on Regulatory Information Management (RIM). There were many significant findings, but I will focus on just a couple in this blog.
One area of interest was understanding if industry was making progress with all the planned investment and changes that were clear in the 2016 study. What surprised us was that despite increased investment in regulatory – both in systems and processes – there has been minimal improvement in overall efficiency and data quality levels, both important indicators of performance. Some areas have seen good efficiency improvements, such as submission forecasting, reporting and analytics, and safety reporting. But health authority interactions, regulatory data management and information standards, and the RIM connection with the product supply release actually declined. Some of the decline can be attributed to the fact that as companies have begun working on these areas, they have realised that it is less efficient than they thought. We also found that submission production and submission content management continued to have high efficiency ratings, especially for the large multi-national companies.
The overall lack of improvement does raise questions. Is it due to lack of a true end-to-end platform where the data and content is housed in one area (like in manufacturing or finance)? The struggle today is that most companies have 3 or 4 solution providers, resulting in disconnected information within regulatory and with key functional areas, which by its structure is inefficient. We also learned that organization strategies also make a difference, including reporting relationship from the affiliate site to the central group and having a dedicated RIM team. Finally, we also know from both the 2016 and 2018 studies that most regulatory organizations have immature continuous improvement programs and struggle with effective performance metrics.
Clear focus on Data Quality Improvement
In addition to assessing efficiency, we also explored data quality or the confidence in the quality of the data (especially the registration / commitment data). When data quality levels are low or moderate it reduces the productivity of the organization. That’s because many regulatory team members spend their time “verifying” information, for example, calling the local affiliate to verify a regulatory event or the status of a label change. These “verification loops” are significant for many organizations and make it harder to do more with less.
When we compared the combined high and moderate data quality levels of 11 information sources, they were identical levels (78%) for 2016 and 2018. Two items that caught our eye were that while labelling information and regulatory intelligence have improved, product registration tracking has declined substantially from 41% having high confidence in 2016 to 23% in 2018. Our hypothesis on this is that in 2016 a large number of companies were carrying out their IDMP assessments, leading many to recognise that their data quality levels were not as high as they had thought. We were glad to see the increases in labelling and regulatory intelligence, two areas that are a challenge for industry.
The impetus behind better RIM efficiency and improved data quality, we believe, is a performance metrics programme. The easiest thing to measure is volume (e.g. how many dossiers did you submit) and service levels (e.g. time from a regulatory event, new product approval, to the status change in the registration system). Those areas continue to track well.
But where organisations can drive real efficiency is from the quality and cycle time metrics. In the study, there were nine quality metrics we measured with only 29% measuring the majority of these and 10 cycle time metrics with only 37% measuring the majority. While there are great aspirations of better adoption of these metrics in the next two years, we shall see if these are incorporated into a discipline continuous improvement programmes.