2026 Regulatory Intelligence and Next Steps in the AI Journey – Organization Implications Pulse Survey

2026 Regulatory Intelligence and Next Steps in the AI Journey – Organization Implications Pulse Survey

Our 2026 Regulatory Intelligence and Next Steps in the AI Journey – Organization Implications Pulse Survey is in full design mode and expecting strong participation from both industry and the software provider community.

This survey will be our 48th regulatory study to date; we expect 35 – 45 companies to participate along with 8 – 10 software providers. The study will be open from July 6th through September 10th with results available in early October to those who participate.

We have been tracking the regulatory intelligence (RI) capability generally since 2016 with focused studies in 2018 and 2022, and now in 2026.

The study (under 20 questions) investigates how effectively companies collect, curate, and distribute regulatory intelligence information, their approach or planned approach to automating these activities, investment priorities, organizational remit, along with a review of the software provider’s RI capability. This is a follow-up to our 2022 industry study so it will be interesting to review industry and the software provider’s progress

We also will continue to track key regulatory AI pilots and implementations along with the organizational implications of AI going forward. We are specifically interested in these dimensions:

  • AI upskilling strategies
  • Level of organizational AI competency
  • New workforce development pathways
  • Resource level Impact
  • Degree of benefit realization

By participating in our study, your company will gain the latest research insights and key practices that improve performance, understand your company’s position relative to industry peers, and an overview of the provider landscape. The study is blinded, no cost to participate, and you get the full results as a participant (~ 50+ pages).

Participants use the survey results and debrief sessions in many ways including:

  • Inform internal strategy and investments.
  • Incorporate practices and metrics to improve operational performance.
  • Understand how they compare to peers (effectiveness, remit, automation goals).
  • Understand common industry challenges, investment priorities, and program goals.
  • Gain detailed knowledge and analysis of the software provider landscape.
  • Educate senior leadership on RI / AI trends, challenges, and opportunities.

To enroll in the study or request further information, fill out the form below.

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    Survey Team

    We have a very talented research team to support this study

    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

    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