Taking RIM to a Whole New Level

data analytics CSC blogs

Why a Strategic Approach Delivers Returns for the Whole Enterprise

By John Bell, Industry General Manager and Americas Leader, CSC Life Sciences

What I’ve being hearing lately from executives across the United States is that Regulatory Information Management (RIM) is taking on a strategic importance in their organizations as it evolves to drive both efficiency and productivity – in some cases across the enterprise.

Not long ago, I met with the vice president of regulatory at a large pharma company, who described the current state of affairs with their regulatory stack. And it’s a story that resonates across most large pharma companies. This company has been separating its regulatory stacks – in other words, a separate regulatory solution for pharma, for medical devices, for consumer products, and so forth. Furthermore, the company has more than 25 different regulatory platforms, making it impossible to get a single view of the data. As a result, there has been no data consistency, no systems consistency and no process consistency.

Now the company is embarking on a transformational journey that will drive process change, organizational change and system change as they harmonize their multiple business units’ regulatory approaches to a model that drives efficiency, transparency, productivity and data consistency.

The timing makes sense on so many levels. From a regulatory point of view, requirements are continuously becoming more stringent, and not just for medicinal products. Medical device regulations are tightening, and that sector will soon be subject to similar regulatory constraints and processes as the pharma sector.

Focus on Efficiency

From a business point of view, the move to harmonize is entirely in keeping with a new emphasis on the broader strategic value. According to a recent Gens and Associates survey of life sciences company managers, four out of five cite global data quality and efficiency measures as a business top priority.  Their world is changing fast and their processes and architectures, and their data and systems, aren’t working. As a result, they’re looking to make significant changes to their RIM capabilities.

As clients change their view of RIM, there are some important factors to take into consideration:

  • Platform neutral: Whatever solution you select, it’s important to ensure that it can be seamlessly integrated with existing platforms to deliver continuity for the organization and improved connection with external partners.
  • User-friendly: You can have the best solution in the world, but if your users can’t use it properly it won’t deliver the results you need. Make sure the solution offers an easy-to-use user interface, while ensuring the core business process engine delivers the capabilities you need.
  • Outsourcing BPS: Consider moving business process services to third parties so your regulatory professionals can focus on higher-value business for the enterprise.
  • Interoperability: Ensure the solution can deliver a practical, sustainable data model that facilitates interoperability and integration.
  • In the cloud: The ability to move to as-a-service frees up capital, allowing companies to move to next generation solutions, and in the process deliver capital efficient innovation.

As the industry moves to next-generation RIM, the opportunities to ensure your solution and processes deliver strategic value across the enterprise become achievable. That much-touted concept of a “single source of truth” becomes a reality, allowing you to save time and reduce errors; expand market opportunities by making information clearer and more accessible; make smart choices about development candidates; ease the M&A journey; and improve efficiency and accuracy across the enterprise.   And your organization achieves Intelligent RIM.

Visit us at DIA eRegulatory and Intelligence Annual Conference, May 11-13 in Philadelphia. We are looking forward to meeting you at booth #500, and show you how to embrace capital-efficient innovation for RIM.

#DIAeRI

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