Mapping the Journey to Big Data Efficiency

There have been numerous conversations lately about Identification of Medicinal Products (IDMP) and what life sciences organizations will need to do to prepare for the standards. The fact is that IDMP is just around the corner (July 2016) and so organizations need to consider how to start or continue their journey, and what approaches make most sense.

By Sharad Khusal, Solution Architect and Customer Service Executive

Over my last couple of blogs I’ve talked about capital efficient innovation from a big picture perspective and from the point of view of application modernization and improving user efficiency. Managing big data – and IDMP is all about big data – is another integral part of improving how the business operates without burdening the enterprise with additional costs.

Therefore the question is: how do you start and what processes do life sciences organizations need to look into and adopt to better manage their data for IDMP and beyond?

Steps to Managing Big Data

Organizations must understand and grapple with the complexity of where their data resides. What I’ve been hearing during conversations with clients is that they aren’t necessarily so concerned about their structured data, which is held in known repositories and applications, but they are struggling to identify their unstructured data, which comprises the majority of data required for IDMP. In other words, these are data elements that are embedded in documents and other filings that are needed for IDMP submissions and identifying them in the first place is a challenge.

The first step is to establish a strategy for managing the data. Is there an existing information architecture in place and can that support these needs going forward or does it need to be supplemented or enhanced to support your IDMP requirements? Or does it make sense to create a separate platform specific to these needs? To answer those questions organizations need to identify their major business drivers: Is it simply about compliance and risk reduction, or is there an element of lowering complexity and improving future ease of use for accessing, filing, and reporting information, or is there a need for better analytics that can be gained from that data? Identifying those key business imperatives will help to define the best strategy to adopt.

Once the strategy has been identified, organizations need to address what capabilities they will need in order to be able to use the data for its intended purpose. For example, if the company doesn’t have repositories to manage unstructured data how will they go about sifting that information? Do they look at adopting big data tools to manage their unstructured data? Do they have a data warehouse solution or are they embarking on one?

Connecting the Dots

It’s important to understand that data resides across the entire life sciences value chain within the enterprise – from R&D and clinical to regulatory and pharmacovigilance, all the way down to manufacturing and the supply chain, as well as the commercial side of the business. Capital efficient innovation with regards to managing big data therefore requires bringing those silos together in order to access information. Regulatory information management (RIM) will undoubtedly be integral to managing the data, but it will just be one aspect of a broader set of applications that organizations have in place to manage their data.

One part of managing data that often gets overlooked is data ownership. As organizations start to put their data management strategies in place, they need to identify who owns the data, so that if information is changed it’s clear who is responsible for managing these changes. From my experience, this is an area that’s not always fully thought through or understood, but it’s integral to a successful big data management strategy with capital efficient innovation at the center.

So how is your organization embracing the big data journey? If it’s not front and center of your strategy for RIM, perhaps it needs to be. Getting value beyond compliance will be the key ingredient to business success.

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