We start the year with a full research plate featuring our 6th large World Class Regulatory Information Management (RIM) study. This biennium survey has become an industry standard and we work very hard to continually improve the design of the study to deepen what we learn. We look forward to sharing the research broadly with the Regulatory ecosystem as our benchmark practice mission is simple: “Everybody gets better”.
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 [...]
Digitalization has been the major point of focus in much of our client work in the past 18 months, but what does Digitalization even mean? It’s not exactly just a shift away from paper-based manual processes and siloed systems, although that is part of the process. Instead, we view digitization as the natural progression of modernization. As your company evolves, much of the new tools and technologies promises to simply, organize, connect, and automate, well just about anything for everyone on your team.
The long-awaited IDMP/SPOR Version 2 EU Implementation Guide was published in February this year, and if my inbox is any indication, companies all over industry are diving into implementation mode. That old urgency we felt in 2015/2016 is coming back, although this time around it seems to me that, as an industry, we are a bit less frightened and a bit more educated. But understanding conceptually what IDMP is, what SPOR is doing, and what the agency requirements are does not make this implementation easy, or even straightforward.
Surviving a pandemic year, especially in the life sciences industry, means that we all had some rude awakenings. But that’s not necessarily a bad thing. Our 2020 Covid-19 study tells us that crisis often forces us to roll up our sleeves to get things done, often with some new found ingenuity and the realization that a better way might exist.
The life sciences industry is under increased pressure and scrutiny to have accurate real-time data, as more of it becomes public and continuously under regulators lens. At the same time, more internal functions are connecting their key information to gain operational efficiency and obtain regulatory compliance with initiatives such as IDMP / SPOR and EUDAMED.
Since early 2019, we have been collaborating with Kelly Hnat from K2 Consulting with both our World Class RIM℠ research and client premier performance workshops. The successful collaboration has resulted in more value for our Premier Members and Consulting Projects and expanded our World Class RIM research to include high priority topics such as the future of structure data submissions and software provider readiness for IDMP/SPOR.
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 COVID-19 Regulatory Impact Survey Results Whitepaper IntroductionOur 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 were responding during [...]
2022 Regulatory Service Provider Market and TAM Report This regulatory software market report provides an independent 3rd party analysis of the regulatory software provider landscape status, key trends and total addressable market (TAM). It includes: Key Regulatory Services Market Observations and Trends Service Provider Current Market Position, Customer Positivity Rate, and Market Position Trending [...]
