The latest ‘industry standard’ survey will be our 47th regulatory study since 2007. The study will be active from September 2025 through December 2025 and will be the 8th RIM study since 2013. The goals of the study are focused on industry’s journey towards operational excellence in Regulatory, highlighting (but not limited to) the following:
- 1.) Determine where industry is increasing their regulatory operational performance and what are their investment priorities
- 2.) Compare study participant “Top Performers” to “Everyone Else” to quantify leading practices that lead to “High Performance”
- 3.) Provide the latest update on short and long-term health authority initiatives and other data standard forums for structured data submissions
- 4.) Explore process maturity for key regulatory processes (change control, impact assessments, labeling, renewals etc.)
- 5.) Review data governance practices and their relationship to data quality levels
- 6.) Explore how advanced technologies (GenAI, NLP, Automation) are being applied along with their investment priorities / budgets
- 7.) Detail the regulatory software provider landscape (market share levels, satisfaction scores, innovation index)
Study goals will be updated after the design sessions in early summer 2025. Study is set to open on September 2, 2025 and close on December 5, 2025. Please use the form on the right to enroll.
By participating in our study, your company will gain the latest industry recognized RIM research (typically over 100 pages) of key trends and practices, your company’s performance position relative to industry peers and our World Class RIM performance levels, actionable insights, top performer practices, automation use cased, and a detailed view of the software provider landscape. The study is blinded, no cost to participate, and you get the full results along with debriefing options.
Industry Enrollment for Study Participation
Core Research Team
We have a very talented research team to support this study which we will be expanding this fall.
Steve Gens is the survey co-founder with the first industry survey conducted in 2007. The 2025 World Class RIM and Operational Excellence benchmark will be the 47th survey conducted under Steve’s leadership. He has over 35 years of business experience with the majority in the biopharmaceutical and healthcare industries. His early career was spent at Johnson and Johnson and then moved into consulting where he managed several healthcare consulting practices for Booz Allen Hamilton and First Consulting Group.
Steve has deep experience in strategy formulation, operational performance improvement, regulatory benchmarking, organization development, and facilitating strategic change. He primarily consults with biotech, pharmaceutical and generic companies along with regulatory software and service providers. He has a specialty in organizations that are experiencing high growth (scale strategy). Steve has a Master of Science in Organization Development from American University with distinction for his field work and a BS in Business Computer Science. Steve is a frequent speaker and was named to the 2017 PharmaVoice 100 and the 2021 innovators for Pharmaceutical Development for his contributions to industry.
Greg Brolund of Chicopee Falls Consulting (supporting survey process since 2009) is a management and technology consultant with experience with global Pharmaceutical companies in product labeling, submission publishing, Health Authority interactions, pharmaceutical safety and pharmacovigilance programs and ICH eCTD, E2B and HL7 ICSR electronic submissions.
He has over 25 years of experience in all aspects of information technology including the Food and Drug Administration’s drug review process and supporting systems and as Chief Technology Officer for the US Department of Health and Human Services. He holds a Masters of Chemistry degree from the American University in Washington DC. Greg can be reached at gregbrolund@cfalls-llc.com
Katherine Yang-Iott is the Research Study Lead and organizational strategist consultant with the Gens and Associates team with over 20 years of experience in the healthcare and pharmaceutical industry leading and managing complex interdisciplinary projects. Trained as a research scientist, she started her career working in R&D within pharma. After her time at Regeneron Pharmaceuticals and The Children’s Hospital of Philadelphia, she expanded to consulting work and content development, focusing on organizational strategies, change management and continuous improvement projects to support research and business operations. This is Katherine’s 4th WCRIM benchmark with the G&A Core Research Team.
Katherine has a Master of Science in Organizational Dynamics from the University of Pennsylvania and a Bachelor of Science in Biochemistry. Katherine can be reached at kyang-iott@gens-associates.com.