Pursuing World Class RIM Part 4: Authoritative Source and Data Standards Update

Steve Gens' new series of blogs are based on the Annual RIM Whitepaper 2016. In the Part 4, he provides authoritative source and data standards update.

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Designation of specific RIM systems and repositories as the authoritative source for regulatory information has been the standard for many years as evidenced by our previous RIM research. In 2016 we took the next step towards understanding regulatory information authoritative sources by asking each company to assess their confidence in the data within the authoritative source for 10 essential capabilities.

Exhibit 13 shows the percent of companies expressing “High Confidence” in the data for each of these capability.


Gens RIM Survey 2016 Exhibit 13.jpg


Fewer than 50% of the companies expressed high confidence in any authoritative source except Safety Reporting. The overall average number for “High Confidence” is only 34%, however there is a significant increase in average confidence across all RIM capabilities among companies with a “common” RIM capability. Companies with a “disparate” RIM capability only report an average high confidence level of 20% compared to 50% for a “common” RIM capability.

Those participants with a relatively low data confidence level in their authoritative sources correlates with the relative low efficiency, achieved benefits and limited ability to report / query common regulatory information in a timely manner.

Limited confidence in authoritative sources also contributes to the anticipated level of effort needed to compile data for required IDMP submissions.

As shown in Exhibit 14, data ownership, governance and organizational changes are key elements to IDMP programs. We believe these activities reflect both the fact that IDMP data is found in multiple organization or functions and that authoritative sources for IDMP data have not be agree upon nor verified to the extent needed to produce a validated submission.


Gens RIM Survey 2016 Exhibit 14.jpg

Although our research indicates there is significant work to be done to improve RIM, we believe the large degree of change that is in progress across the industry will result in more efficient management of regulatory data and an improvement in the quality of regulatory information.

We also modeled the anticipated total industry spend for IDMP compliance several times and will conduct a final analysis once the specification is finalized. Our latest thinking is a total spend of $410 million dollars for the top 250 with 55% being business related (data remediation, manual process development, initial data load), 26% being project analysis (detailed gap analysis and program oversight), and the remaining 19% being technology spend (information staging area and the actual submission technology).

Published on 03/01/17    Last updated on 03/01/17

#Regulatory Information Management (RIM)

About the author

Steve has over 25 years of experience, primarily in the biopharmaceutical and healthcare industries. After leading many technology and business process initiatives for Waterford Crystal and Johnson and Johnson, he developed an interest in global teams and organizational performance. He moved into consulting where he built and managed several healthcare consulting practices for First Consulting Group and Booz Allen Hamilton. Steve has deep strategy formulation, organization development and performance, global workplace collaboration, industry benchmarking and information management strategy expertise. Steve holds a Bachelor of Science degree in Business Computer Science and a Master of Science in Organization Development with distinction for his field work from American University. He is certified in Change Management from the NTL Institute of Applied Behavior and is a frequent speaker with several publications.


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