Closing the loop: How building value requires an enterprise-wide approach

By Sharad Khusal, Solution Architect

Over the many years that CSC has worked in the life sciences space, we’ve come to understand not only the specific needs of clients with regards to our industry solutions and services, but also the bigger picture – the trends and pain points, the industry and organizational challenges, and the opportunities.

The industry challenges are all too familiar to our clients: regulations, price pressures, patent protection, the high cost of R&D combined with the uncertainty of the clinical trial process, the risks associated with adverse events, competition from me-too drugs, and the high cost of flaws in the manufacturing process.

The fact is that the issues the industry faces are complex and they impact the entire organization – not just regulatory. It’s vital that companies manage these issues holistically, or the consequences can be far-reaching. For example, lack of quality control in manufacturing can result in drug recalls resulting in poor brand recognition, while patent loss results in reduced profits as sales fall.

Progressive pharma companies are looking at new ways to develop innovative therapies, including collaborative research, translational research, broadening the geographic scope of clinical trials, the use of analytics to improve data transparency and gather insights, and partnership with CROs and other key vendors. The emphasis is on continuing to build value in a constrained business and regulatory environment.

More with Less

We’ve been using the term capital efficient innovation to describe that critical concept of building value for the business without additional cost. In other words, how do you do more with less? That really is the Holy Grail for companies who are often constrained with technical debt accumulated in their legacy systems and fewer resources at their fingertips in which to innovate.

That brings me to our vision for a holistic approach to capture that capital efficient innovation. As our clients know, the life sciences industry is embedded in our DNA, from our expansive services to our multi-layered solutions that: 1) manage all the content required for a regulatory submission (FirstDoc); 2) simplify the submission process to regulatory agencies worldwide (TRS eCTDXPress); and 3) track all submissions globally (TRS Tracker).

Looked at together, these three areas, coupled with our business process outsourcing services that take on the entire burden on behalf of our clients to expeditiously submit dossiers to the regulatory agencies, are integral to regulatory information management (RIM). Our expertise in these areas isn’t news to clients, but where there is a lack of awareness is in the larger knowledge, history, and best practices that our solutions and services can bring to the table.

But achieving RIM requires far more than robust software solutions; it requires a complete set of solutions and services. Some of those are integral to our wider business – whether it’s a new user experience, cloud, applications modernization, cyber security, or big data and analytics – and some are provided by our strategic partners. That’s a crucial point: it’s both unrealistic and unproductive to think one company holds the answers to every issue. That’s why we partner with vendors who are leaders in their fields. It ties in with an outside-in approach that has become fundamental to the way we operate: best-of-breed partnerships, open source, scalable and flexible, and customer-centric.

Overcoming Barriers

From speaking with clients, the watershed has come as a result of trying to juggle point solutions often from working with multiple vendors without continuity across functions, without a comprehensive process across the organization, and without a broader view to the entire business. And that can be a huge barrier to innovation.  The next generation life sciences’ company needs a partner that understands the complex nature across their IT landscape, business processes, critical dependencies, and pervasive need to show return on years of investment.  It’s no longer a game for the single minded when trying to achieve RIM.

Another key point for companies today is finding the value-add to their RIM capabilities. Done properly, cohesively and strategically, RIM is about far more than addressing your regulatory issues to achieve compliance. It’s about the real benefits that accrue, be they cost savings, using the knowledge stored in regulatory to enhance R&D, providing marketing with valuable data, or simply building closer relationships with customers and partners.

Over the coming months we’ll develop a series of blogs that explore various angles of RIM and capital efficient innovation, including user experience, cloud and its role in better management of the business, application modernization and improving user efficiency, and big data – the knowledge in your IT bank.

We would also welcome your thoughts on what RIM means to you and what achieving RIM will mean for your organization.

 

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