Data: the key to the operational agility in life sciences

Unless companies improve their use and manage data, they can’t hope to become more flexible, innovative or efficient, warns AMPLEXOR’S senior life sciences consultant, Siniša Belina.

When markets as conservative and compliance oriented as banking and healthcare are being disrupted, it stands to reason that life sciences cannot afford to rest on its laurels. Whatever red tape it is shackled by, it too must heed the call to become more agile and innovative – able to respond to changing market demands.

But there is a major sticking point: data. In the industries being disrupted, this has provided the key to new discoveries, insights and opportunities, and the ability to turn these into new services. The ability to consolidate, mine and readily access and repurpose data is at the heart of some of the most ambitious and successful new business models.

Data exploitation and information management are highly complex, particularly in life sciences, and bringing multiple sources together in an intelligible form is a tall order. Assets might range from structured database files to spreadsheet entries, manual notes, emails, and PDF scans or attachments. It is hard enough to combine these diverse sources, let alone reliably cross-analyse them for potential insights.

Increased merger and acquisition activity – a sign that firms are looking for shortcuts to get new offerings to market – adds to that complexity, slowing the speed with which those strategic additions can start contributing fully.

Life sciences firms have been puzzlingly slow to recognise that data management lies at the heart of many of their operational agility challenges. The hope was that the forthcoming ISO IDMP product information standard would provide a clear driver and robust financial case for getting their data assets in order. However, repeatedly shifting deadlines[1] and a lack of specific enough guidance have caused many companies to lose momentum.

In the process, firms are jeopardising their responsiveness to new opportunities. To be able to capitalise on new possibilities, companies need to have core data in order – a single version of the ‘truth’ about their products, which they can call up readily to support an infinite number of purposes, old and new.

Although new technology deployment models can help with some of this, they are not a solution in themselves. If the core data is incomplete or unreliable, firms will be no better off. This is why, in their drive to be more agile, they need to return to the premise of IDMP, even if some of the finer detail is still to be confirmed.

One focus should be transforming information management from something document-based to something data-oriented – i.e. more dynamic, granular, structured and searchable. (A 100-page PDF for example would become more component-based, broken down, stored and recallable as a series of reusable information assets.)

‘Data’-based information management makes it easier to observe, analyse and report patterns, and draw conclusions. It would mean companies are able to spot patterns in queries received from the authorities in relation to products or submissions, so that these could be pre-empted and delays avoided.

As things stand, ‘good data’ scenarios are a rarity, accounting for less than 10 per cent of companies’ information management practices. So there is much work to do. IDMP’s more distant deadline gives companies a chance to catch up, their operational agility depends on it.

[1] Implementation of ISO IDMP standards, EMA latest: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000645.jsp