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Structured authoring is an approach that has eluded life sciences, limiting firms’ ability to transform routine regulatory processes. But this could all change, writes Romuald Braun.
In other industries with complex information and document needs, such as aerospace engineering, creating smarter documents populated with pre-approved information components is accepted practice. Yet up to now structured authoring is an approach that has eluded life sciences, limiting firms’ ability to transform routine regulatory processes. But this could all change, enabled by technology advances – as long as those affected are on board, says Romuald Braun.
In disciplines with complex information needs, such as engineering, used of structured authoring is second nature – especially in regulated industries. Across organizations spanning automotive, aerospace manufacturers and power utilities, there are teams of people who routinely coordinate structured content, populating complex documents with approved information components. The practice spans all aspects of operations, from research and design processes to regulatory information management.
In life sciences, the set-up has traditionally been quite different. Take the teams responsible for preparing content for regulatory processes. These tend to come from very different backgrounds –medical doctors, pharmacists and chemists. As a result they have tended to favour simple office-style content tools for generating documents – such as Microsoft Word.
Yet this has meant that, other than manually cutting and pasting from existing documents, teams have typically had to go back to the drawing board each time a new or updated submission is needed – finding the right data all over again, and assembling it under the required headings. A process that is at best inefficient, and at worst laden with risk of error.
Until now, it has been hard for life sciences firms to do much about these practical constraints, due to departmental information silos and practices - and the difficulties of harmonizing these. But technological advances offer to change all that. Today there are solutions that promote the concept of a single, master data and content repository, for instance - inspiring greater data hygiene and discipline. It’s also easier to enable users to find and use the data they need intuitively – e.g. through the ability to automatically populate Word-like document templates.
There are a number of drivers for establishing more efficient, reliable and automated document-building processes. Certainly this is the way regulatory authorities are heading in their evolving standards and compliance requirements (standards like ISO IDMP place heavy emphasis on data quality and data management regimes). In addition, cost pressures on life sciences firms are increasing all the time. A further impetus is the growing pressure on the life sciences to be more transparent, with ready answers available on demand and more detailed reporting.
The practical challenge is how to get to a data-driven approach to broader content management – i.e. from the current monolithic way of creating regulatory documents, to a much more structured and more readily automated method. This all starts with a single, definitive source of “product truth”.
The foundation for progress is strong, complete and reliable product master data, expressed in standard terminology and formatting. Once this is available “off the shelf”, it can be repurposed to support any number of use cases in a clean and easy way.
Yet this requires tight integration between systems and the core data source, so that nothing has to be re-entered between departments. It also requires that users can easily find, capture and re-use the right information in a way that feels intuitive - i.e. without special training. Via a simple web interface with the feel of Microsoft Word, for instance. Where users are more technically adept, and want to dig a bit deeper into the back-end systems - perhaps for qualification or validation purposes - this should ideally be possible too.
Already, life sciences organizations are expressing keen interest in adopting this type of strategy, recognizing that, once they have identified and finessed some approved master data combinations which can be used repeatedly in different content scenarios, they can start to automate the compilation of some of their more routine documents. This is where the potential for productivity and efficiency gains multiplies.
It is important to realise that the transition to structured authoring and its fullest potential could take months or even years, however. One pragmatic way forward is to plan the transformation across a few distinct stages.
Beyond working towards good master data, companies might decide to transform simpler document production first - the kinds of submissions that re-use a lot of the same data, expressed in a very similar way, time after time.
Other documents, such as clinical study reports, will have a higher proportion of unique content – flowing narratives, hypotheses and interpretations of findings. Although parts of these documents will lend themselves to automation, based on approved data combinations or content “fragments”, compiling the fuller report will require a hybrid approach – part structured authoring/automation, part manual assembly. The benefit of structured authoring here is that less time needs to be spent on ‘stock’ content, and more focus can be devoted to developing the narrative.
The aim should be to work towards a single, central platform for not only master data but also approved content fragments ready for structured authoring, maximizing the opportunity to quickly and reliably create new documents – or roll out data changes. So if the ingredients of a drug or a manufacturer’s process change, this information can be reflected promptly and confidently across all regulator notifications and revised labelling in all affected markets. This is an application that has captured the interest of many life sciences companies already, for fairly obvious reasons.
So what does early best practice look like? Pilots and early rollouts to date suggest the following:
The impact of developing a roadmap and applying these measures will be multi-faceted.
Exploiting structured authoring based on approved master content will accelerate submissions for new products or additional market entry, and improve ongoing compliance, maintaining market status. Once you have a structured, automated emphasis to document creation, quality and compliance are achieved by design.
This in turn could lead to operational cost savings, freeing up professionals’ valuable time and allowing companies to think laterally about additional market opportunities which now begin to look more viable economically.
Restructuring has never looked so appealing.