Seeing the big picture: Why RIM has to be more than regulatory software

In my conversations with clients, one trend that is becoming apparent is the need for a far more comprehensive approach to managing regulatory information across the enterprise. Organizations are looking for their service provider partners to help them leverage their information and achieve greater efficiencies, and this needs to go beyond software. But while I’m seeing more vendors enter the registration management solutions market, this is only a small element of a much broader emerging regulatory information management (RIM) landscape.”

By Gurdip Singh, Vice President and General Manager, Healthcare and Life Sciences Software and Solutions

The fact is that RIM needs to be conceptualized at a more expansive level, because it has to reflect the life sciences organization of the future. Progressive life sciences organizations can’t thrive solely on developing and marketing new drug therapies. Rather, the life sciences organization of the future has an enterprise-wide systems’ sophistication that enables them to be smarter, faster, and manage activities at a lower cost.

These organizations will survive in the Life Sciences 2.0 paradigm, but to do so, we at CSC believe that to they need to adopt a capital efficient innovation model, which at a RIM level the move is from effectiveness to efficiency, ultimately driving toward a more capital efficient model. While RIM is undoubtedly about improving regulatory systems, that’s not the end of the story. Rather, capital efficient RIM:

  • Scales across the organization, bridging organizational silos and enabling information sharing across business units seamlessly
  • Encapsulates the vision of outcome-based solutions, through measuring, monitoring and integrated business processes
  • Produces actionable intelligence to improve profitability and patient outcomes – simultaneously

CSC’s competitors are only now coming to this realization, and attempting to come up with a solution for registrations. This realization is important, as without it RIM can’t be fully achieved. But we already have a strong track record here with CSC’s Tracker, which has been in the marketplace for years and is a proven solution, trusted by many clients.

We see RIM evolving as a reference architecture that includes a core baseline set of products that life sciences organizations require in their portfolio – content management, submissions and publishing, and global management of product registrations.

These are the “bread and butter” software products that CSC has delivered to the life sciences community for years, bringing best practice process and evolving technology capabilities to support a highly dynamic market. Our software products are the core underpinnings of our “RIM Reference Architecture,” and are functionally rich and cater to the needs of our clients.

Best of Breed

In fact, at the DIA eRegulatory and Intelligence Annual Conference held in May, one of our clients, Tobias Massa, Ph.D., vice president of global regulatory affairs and head of regulatory operations at Sanofi US, delivered a presentation on “Global Regulatory Operations Platform and Technology Enablement” that underscores CSC’s importance to Sanofi as a partner. In a chart developed after a three-month engagement to assess the industry’s best products in the market, he placed CSC in the “upper right” quadrant both in terms of delivering “Scope of Services” (product vendor capability to provide regulatory authority software, consulting, and BPO services) and “Technology Fit to Purpose” (fit to Sanofi requirements). In other words, CSC ranked highest in both Scope and Fit, measured in a field of 17 vendors.

Another often-overlooked aspect of delivering first-rate service and capabilities is the willingness, and ability, to bring together best of breed partners to fill in gaps, since no one organization has all the pieces of the puzzle, and allows clients to build an agile portfolio. CSC partners with organizations, such as Wingspan, ArisGlobal, and Kallik and many other industry leading best-in-class regulatory products.  In addition, we partner with industry giants like Oracle and specialists like ProductLife Group to deliver the full stack of software, services, and consulting.

In our RIM 2.0 vision we take a layered approach to helping our clients achieve capital efficient innovation, and therefore become smarter, faster, more agile enterprises. CSC’s full stack of software, services, infrastructure, application modernization, and business process services means that we can help our clients achieve that capital efficient innovation, through a holistic approach to achieving RIM.  We acknowledge that the first step in a comprehensive RIM solution is having the core regulatory software, including registration tracking.  But, clients today need so much more – and we are positioned to deliver the complete solution.

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