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 [...]
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 [...]
2022 World Class Regulatory Information Management (RIM) Study Whitepaper Fall Edition: Based on our 2022 World Class RIM℠: Accelerating Business Value Study (n = 76) Our biennial World Class Regulatory Information Management (RIM) study focused this cycle on understanding how industry is accelerating business value, on the status of the regulatory [...]
2022 COVID-19 Regulatory Impact Follow-up Survey Whitepaper (Summer 2022) Introduction In the spring of 2022, we followed up on our 2020 Covid-19 Regulatory Impact research to see how regulatory organizations were evolving with the ongoing pandemic. In our original study, conducted 6 months into the pandemic, we learned how companies tapped into [...]
2021 Enhancing Quality Beyond Compliance Whitepaper The study goal was to establish a baseline of where industry is currently at with Quality across their organization, while also developing a deeper appreciation and understanding of the different approaches to Quality and the impact it has on elevating organizational performance. 22 companies participated during the [...]
2020 COVID-19 Regulatory Impact Survey Results Whitepaper Introduction Our 2020 pulse survey focused on the effects of the Coronavirus Pandemic (COVID-19) on regulatory organizations across the globe. The research was designed to explore different short- and long-term regulatory impacts that organizations may have been experiencing and aimed to explore how those companies [...]
2020 World Class Regulatory Information Management (RIM) Whitepaper Fall Edition – Based on our 2020 World Class RIM: Is Industry at a Performance Tipping Point? Study This paper provides insights from our 2020 study, explores pathways to achieving a high performing RIM program, and highlights learnings from the study top performers. We review [...]
The Evolving Role of the Regulatory Affairs Professional By Preeya Beczek - Independent Regulatory Affairs Expert Typical Eras and Environments for the RA Professional Key skills and qualities of a RA professional Key RA skills as an Operational Resource Key RA skills as a Business Leader Key RA skills [...]
Regulatory Information Management (RIM) is one of the highest priority investment areas in Life Sciences R&D today, driven by the need to greatly improve the efficiency of regulatory globally, currently averaging 43% across 18 RIM capabilities[1], and manage regulatory information as a true enterprise asset. In this paper, we will examine why – even now [...]
Regulatory Information Management (RIM) is clearly transitioning to an enterprise capability with growing connections to other critical functional areas while some potential “game changing” technologies emerge. Our 2016 World Class RIM baseline has now moved to an industry standard based on our 2018 research results and input from 31 contributing companies in our design [...]
