2026 Regulatory Software and Advanced Technology Market Report (May Edition) This regulatory software and advanced technology market report provides an independent 3rd party analysis of the regulatory software provider landscape status, key trends, and total addressable market (TAM) including: Industry Performance Status and Key Trends Advanced Technology (AI / Automation) Status, Investment Priorities, [...]
Gens & Associates’ new World Class RIM℠ study identifies “secret recipe” for Regulatory functions’ “future readiness” — and it has little to do with AI Fresh benchmark data from 59 life sciences organizations finds most biopharmaceutical companies currently ill-equipped for a “confluence of change” already underway and pinpoints the foundational practices behind a widening [...]
2025 Operational Excellence and World Class Regulatory Information Management Study Whitepaper This whitepaper reviews key learnings from the 2025 study, including industry performance status, future readiness for projected changes, authoring paradigm transformation, regulatory process maturity, advanced technology application and benefit realization, and the software provider landscape. The paper also highlights the practices of [...]
What ‘Operational Excellence’ Looks Like for the Evolving Regulatory Organization This positional paper redefines regulatory operational excellence as the balance of delivering results today while building future readiness, setting the stage for new benchmarks in how regulatory organizations evolve Download Whitepaper
Regulatory Software Provider and Advanced Technology Market Report (June 2025 edition) This regulatory software and advanced technology market report provides an independent 3rd party analysis of the regulatory software provider landscape status, key trends, and total addressable market (TAM) including: Industry Performance Status Advanced Technology (AI / Automation) Status and Investment Priorities Software [...]
2024 World Class Regulatory Information Management Study Whitepaper This whitepaper reviews key learnings from the 2024 World Class RIM℠: Extending the Power of RIM study, including industry performance status, investment priorities, strategic data management, regulatory digital strategy status, advanced technology application, and the software provider landscape. The paper’s information and graphs are [...]
The 2024 WCRIM Study – Extending the Power of RIM reveals a jump across all performance measurements in our industry standard benchmark since 2022. The data from the current cycle of our research illuminates a clear path to achieving high performance and the degree of performance improvement is driven by consistently applying strong organizational practices, process maturity, and building up data governance.
2023 Optimizing Affiliate Engagement Regulatory Survey Whitepaper This White Paper reviews the key findings from 320 local affiliates representing 94 countries that participated in our study during the summer of 2023. The study was designed to capture and examine the “voice of the affiliate” to improve global regulatory activities. The paper reviews [...]
You may have heard of the saying to ‘treat feedback as a gift’. If so, then our latest study feels like a gift that keeps on giving. Our 2023 Optimizing Affiliate Engagement to Improve Performance of Key Regulatory Activities survey is a landmark study designed to capture the voice of the affiliate. As most life science companies want to be better and get better at managing key regulatory information on a truly global scale, improving how affiliates work and how headquarters interacts with and supports those affiliates are critical components.
Gens & Associates launches latest World Class RIM℠ study – the largest yet – to define & hone “industry standard” practice Stakeholders across the global Life Sciences industry & regulatory provider community are invited to play their part in cementing the ultimate approach to regulatory information management Newtown, Pennsylvania, USA – October 4th, [...]
