What is the Path to High RIM Performance?
By Steve Gens MSOD
We have learned “what works to improve performance” from our extensive regulatory information management (RIM) research and client projects with over 120 organizations. Since our 2014 RIM benchmark study and for each RIM survey since, there is no correlation between top performers to any one software provider or system strategy; top performers excel at process and organizational work along with strong implementation execution.
Our study top performers are defined as those companies that fall into our strong performance and world class levels. Performance is measured by efficiency of 15 RIM capabilities, business benefit realization, metrics / continuous improvement program effectiveness, global reach, time to process information, and data quality confidence of key regulatory information systems.
Sometimes, organizations get too focused on what we call “the shiny object” which is technology. Technology is a critical enabler and should streamline operations and improve productivity, but the foundation is built upon the organization and process pre-work and often in continuous improvement programs; the work is “non-technology”, meaning process, people, roles, decision rights, data standards, etc.
We developed our Path to High Performance model as a result of our 2020 World Class RIM study (n = 70) and use it extensively in our consulting work as a guide and diagnostic to help improve performance for our clients and members.
Starting at the bottom of the figure above, there are many organizational strategies that help improve performance, but we focus on KPI & continuous improvement Program which we believe should have either dedicated staff from a full-time job in larger organizations or focused role(s) in smaller organizations. This goes hand in hand with a proper data governance structure (we have a detailed model) with the proper leadership advocacy and a culture of quality “mindset”. Getting it ‘right the first time’ is common in functions such as Manufacturing and Clinical, however it needs strengthening in the global regulatory environment. Finally, having clear roles AND decision rights for individuals and teams makes for a better performing organization.
Too often, companies search for the “best practice” when it comes to process work. We strongly believe this is misguided as a best practice for one organization does not equate to a best practice for another. Process Maturity on the other hand focuses on maturing processes from “daily heroics” which is inefficient and filled with inspection risk to an “optimized process level” where clear metrics and continuous improvement support evolving processes based on regulatory and geographic complexities. The most common targets for improving process maturity are the change control, label management, global dossier, and new marketing / investigational applications.
So, the math is very easy here! The better you are at the organizational level + high process maturity = better use of your technology choices and therefore higher business benefit realization.
