How IDMP Might Be the Catalyst to Achieving RIM Nirvana … with a Little Help from Your Friends

The life sciences industry is being propelled toward a compelling event: the advent of regulations concerning Identification of Medicinal Products (IDMP). Granted, there’s uncertainty about what it will look like or even when it will be implemented, but it remains imperative that companies are ready.

By Paul Attridge, Life Sciences Product Director, CSC

At its end-game, which is the International Organization for Standardization standard, IDMP is an all-encompassing set of standards that will bring together data concerning many different aspects – Clinical Particulars, Pharmaceutical products, Substance Definitions, Packaged Medicinal Products, Medicinal Products, Manufacturers, Market Authorisations – designed to promote the exchange of medicinal product information between regulators and pharma companies. To be able to comply, and before implementing a solution,  companies are required to look at the systems they have, understand where the data is, understand the consistency and quality of the data, implement a strategy for harmonization, and identify their solution requirements.

There’s an enormous amount of information that companies will have to map out, and while there might be a repository to hold that information, the answer to IDMP won’t come from a single system, but rather from getting these different systems to talk to each other. That task – systems interoperability – will require some work by both pharma companies and their vendor partners.

Catalysts to Change

Companies and regulators are starting to realize that this presents them with a master data management (MDM) issue and that they need to solve that problem, and if they can they will be able to deliver regulatory compliance.

There’s also an internal driver to realizing MDM, which is the growing need for intelligent regulatory information management (RIM) from a business perspective. The question is how best to move toward MDM in a way that supports a progressive RIM strategy and that meets their IDMP requirements?

Pharmacist in front of a cabinet

Many companies will have three or four different systems that contain similar information or representations of that information, and so they need to look at which is the right one – in other words, which is the master. If none are the master they need to decide which of the systems they want to be the master, and then make the other systems collaborate with the master. Driving toward interoperability of systems will be necessary to solve many of the data challenges that IDMP presents.

The initial part of this is going to be a readiness assessment – mapping out that data and finding where it sits. Once you have that, you can then move forward and assess how to collect and cleanse that data, before defining your system requirements for the MDM solution so it can be managed appropriately.

Once companies start uncovering data management issues, it becomes something of an awakening – they start to realize that with a clearer MDM strategy they can understand a bit more about how they operate and start redefining their business processes to make them more efficient. That in turn enables them to take less time or use fewer resources on managing their data, which in turn helps them optimize elsewhere in the business.

Vendor Collaboration

That brings me to our role in this. CSC understands that the nirvana for life sciences companies is an end-to-end RIM business process that takes them from late stage clinical trials to monitoring drugs in the outside world.

We believe that is attainable, but that it requires extended systems and partnership. The fact is that most companies have a variety of commercial off-the-shelf (COTS) systems in place, and they need interoperability between those systems. So what companies need is for their vendor partners to work together.

We realize we can’t do it all, so we’re enabling our solutions to live in an environment that contains solutions from multiple vendors, and to cooperate with those solutions. So if a customer has a third-party solution in place – whether it be a publishing system, or content management system, or registration tracking system, or any other solutions – we are enabling our products to talk to them, creating an intelligent RIM platform with an integrated, holistic approach.

We’re already talking to our strategic partners in the areas of registration management, publishing and content management. And we’re investing in our own products to enable them to work with other solutions. The outcome of that will be a set of interfaces that customers can put into their own enterprise environment to enable collaboration. For example, our next version of RegTracker will be delivered with web services for interoperability. We already deliver web services with FirstDoc, which can deliver a lot of value for a customer already without them needing to go and invest in significant development or coding activities.

So we’re making huge leaps forward with our solutions to enable that interoperability. It’s not just going to be complete out-of-the-box delivery around the integration map, and customers will need to do things for themselves, but what we’re doing is making interoperability possible so our customers have what they need to achieve compatibility.

Ultimately all of this will make it that much easier for companies to go beyond IDMP compliance and drive intelligent RIM.

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