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, [...]
Improving Data Quality with better Data Governance cross-functionally is a “hot topic”. Companies are investing in people and technology to get more out of their information assets, realising this through large system and process modernization, plus the ability to connect data across functions, and the bottom line is “the quality of information in systems has to improve - period”. Great things happen when there is high confidence in the information we use as regulatory professionals every day – speed, better decisions, efficiency, and trust.
It’s been an interesting 12 months to say the least with ArisGlobal buying both Amplexor and SPORIFY, Ennov buying Samarind, Calyx divestiture from PARAEXEL only to be acquired by CapVest/GLO Healthcare in Q1 2023, and Honeywell buying Sparta Systems. We also witnessed some successful partnerships, especially the combined Generis/Extedo capabilities in both systems and services.
Regulatory Intelligence 2022 Study Whitepaper This 10-page whitepaper summarizes the learnings from the December 2022 Regulatory Intelligence Pulse Survey of 42 organizations representing industry and 13 regulatory software providers. The paper is structured by: Introduction and Executive Summary Study Background Regulatory Intelligence Model and Department Remit Automating [...]
