Gens and Associates Blog

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.

The COVID-19 Pandemic continues to make its global impact on Regulatory organizations. Since March 2020, the entire life sciences industry transformed in many ways to develop, produce, and deploy innovative treatments for this disease that has caused so much global destruction.

In an ideal state, Regulatory’s use and adoption of advanced technology would be swift, far reaching, and effective. But this is easier said than done. Managing regulatory information is highly complex, in part, because requirements vary and often change across geographic locations.

Our benchmark data doesn’t just measure current industry experience and trends, we also strive to understand the cultural indicators and motivations of organizations, what we are calling the “secret sauce”, that creates the optimal environment needed to support performance improvement for Global RIM programs.

The results from our 2020 World Class RIM℠ Survey, “Is Industry at a Performance Tipping Point?” was released this May with 66 companies participating in the study.

When John Cogan and I connected at the February DIA show in Washington DC this year, we began chatting about “what’s holding regulatory back”? Life sciences companies began increasing their investments in regulatory information management (RIM) capabilities between 2014 and 2016 and many are still not seeing measurable improvements.