Structured content authoring is transforming drug approvals processes

Structured content authoring is transforming drug approvals processes

by | Aug 17, 2023 | Digital Transformation, Fonto, Life Sciences, Technology Services

Guest post by fme partner Maarten van Vulpen, Customer Success Manager, Fonto

In this dynamic, digital era – and in the context of expedited drug approvals processes, post pandemic – continued reliance on static, single-use Word documents to capture and publish or exchange critical information with Regulatory agencies makes no sense. It is hampering productivity, efficiency, compliance and visibility. Fortunately, there is a better way. Structured content authoring is already transforming drug approvals processes in Life Sciences.

In other industries, including the precision engineering and manufacturing-based automotive and aerospace industries, the automatic re-use of approved, structured content assets (fragments of approved text) is well established. Automatically generating onward documentation from a single source of approved content truth is the key to accuracy, reliability, and traceability as well as process efficiency.

And now Life Sciences, as it undergoes digital transformation, is beginning to recognize and reap equivalent benefits of structured content authoring (SCA) and automated content re-use, with a powerful impact on internal process efficiency.

There’s a practical imperative to this, too. In a bid to accelerate the approval of important drugs and make their own processes more efficient, health agencies are become more digital and dynamic in their information management and exchanges – an expectation they are passing on to drug manufacturers and license holders.

Yet, as long as these companies persist with Word/Excel/PDF based information and content management, they will only be creating more work for themselves in their efforts to keep up with those changing demands.

Driving new value from existing information with structured content

Pharma companies are already rich in regulated product information. The challenge is that much of this exists within single-purpose documents, dotted around different systems across the organization. This means that for each new purpose, teams have to go through protracted and laborious processes to locate, piece together, and seek approval for each new document use case – whether they’re generating a study report, submitting a new marketing authorization application, registering a product change, or updating labelling.

Structured content authoring tools like Fonto Editor strike right at the heart of this situation, transforming the way pharma subject matter experts (eg Clinical Trials, Regulatory, Quality or Safety teams) collate, publish, and manage vital drug information right across the product development, registration, and marketing lifecycle. Crucially, they are able to do this without having to brief out the content creation to technical writers, then check and approve their output. That’s because the SCA solution is intuitive for users, offering them a very familiar, Word-like experience, while building from content dynamic, reusable digital content assets.

Although there isn’t yet a single, agreed standard or schema for how documents should be constructed across Life Sciences globally, this will come in time and companies will be able to adapt to this relatively easily. That’s as long as they have got to grips with structured content authoring – and the immense scope for more reliable, efficient, and repeatable use of regulated information across a wide range of applications.

Transformation from the core

An obvious place to start in the adoption of SCA in pharma is the core data sheet, a key document representing the pharmaceutical company’s position on – and the definitive, correct, and current truth about – a product.

Once the core data sheet’s contents have been structured and stored as a series of digital content fragments, they can be flowed into a whole host of other documents including submission applications, reports, labels, and clinician/patient information, without risk of manual error – or the need for new rounds of internal content checks.

One of the top 5 pharma companies globally has already seen a 15% increase in productivity in processes linked to drug approvals, since adopting Fonto Editor to more automatically generate content that sails through internal checks.

By combining both Fonto and fme’s knowledge and experience with advanced ECM solutions, pharma professionals get several benefits. First, Fonto shields them from having to understand the ins and outs of XML formatting – a substantial win and time saver. Second, teams from across the drug lifecycle can gain seamless access to SCA capabilities from within their existing regulatory information management (RIM) platforms as a natural extension of their everyday work.

fme & Fonto: a formidable SCA partnership in Life Sciences

fme and Fonto share a strong pedigree in transforming Life Sciences content and data management, working together to integrate and embed SCA within companies’ Veeva, OpenText Documentum, or Generis CARA, or other systems. This means that relevant functional teams can shift to structured content management and authoring without having to learn to use new, separate tools.

For more details on structured content, Fonto has presented, and continues to present courses on the potential for structured content in Life Sciences via the Drug Information Association (DIA) – here’s a link to a recent session.

 

 

As the Life Sciences industry grows more serious about digital process transformation, fme has been highlighting the potential of SCA, too. In this post from fme’s Manuela Bernhardt, she explain that “Data is the heart of the business, whereas documents are the ‘packaging’ to create context”.

 

 

A dynamic pharma future needs structure

Over time, the opportunities for transforming content management processes through re-use of approved digital assets with at least some degree of automation will only grow. The regulators, as well as competitive market pressures, will demand it; meanwhile technology vendors like Veeva will continue to pave the way for powerful content re-use, as long as this is planned properly (for instance, with the support of RIM vendors like Veeva delivered through specialist Life Sciences partners like fme and Fonto).

To find out more about the potential for structured content authoring and management in your own organization, download this data sheet covering fme and Fonto offerings.

Download the datasheet
Click here to learn more about Fonto’s partnership with fme.

Or contact us to start the discussion today!

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About the author

Maarten van Vulpen is customer success manager at Fonto, the leading solution in structured content authoring. This role gives Maarten the opportunity to discuss structured content authoring, its advantages and innovation with customers and potential customers from multiple industries, including life sciences. 

What Digital Transformation Has to Do with High Jump – Thoughts on the Current Buzzword

What Digital Transformation Has to Do with High Jump – Thoughts on the Current Buzzword

by | Mar 5, 2018 | Digital Transformation

Digitization – Digital Transformation

First of all, I notice that the term “digitization” is often referred to as “digital transformation”. In my opinion, this should be clearly separated from each other.

I see digitisation as the transition from analogue to digital. This is, for example, the replacement of paper documents (holiday request, material requisition, travel expense report, scanned invoice) by forms/dialogues on the intranet. The advantages compared to conventional in-house mail with only one analogue copy are clear: faster processing on the computer without waiting times. And other new technologies and applications (e. g. mobile devices, sensors, networking and apps, frameworks, cloud storage…) ensure that more and more areas are opened up for digitization by computer science/IT.

Although this is a change (transformation) it does not mean a great revolution, but rather an expected steady growth, as it is to be followed e. g. also with progressive motorization and automation. With the usual procedures “look for qualified employees and regularly train them further; adapt the product range to the latest technology, remain innovative in your own core business” you will continue to do well… or should we use the subjunctive “would”?

An important point is the progressing digitization as a basic building block for the real “Digital Transformation”: the digital twins! The images of the analog business objects of the real world are now digitally and cross-linked available.

A striking technology for this is the emerging Internet of Things. In my opinion, this is still very experimental at the moment with funny gadgets or questionable pseudo products… But also the first steam engines, airplanes, computers and mobile phones were smiled at.

Disruptive developments

Undoubtedly and very attentively to observe is the immensely increasing generated connected data volume. Today, the technology is also available to record these data volumes as Big Data. In addition, the methods of artificial intelligence (AI) and machine learning (ML) have been added to the processing and use of this data. These data volumes can thus be controlled.

With these new and simultaneously occurring aspects, all the necessary ingredients for a disruptive development full of force and speed come together, as if the three aspects would unite as single waves to form a tsunami-like “monster wave”.
And it is precisely this wave, which is rolling towards established companies, that must be taken into account!

(Digital) transformation

This is because the processes, from customer requirements to product selection/purchase to service and support, are subject to constant change. With changing business models or completely new distribution channels, the importance of companies’ product know-how and the experience of employees towards a unique selling point can decrease. From my point of view, only these completely changed processes are the “digital transformation”.

Let’s get back to the paper documents mentioned above and their digitization in the Intranet/Internet. Is it possible to approve these documents automatically? Can an AI learn to handle the simple cases autonomously, send only complex cases to manual approvers for manual approval, and even discover hidden errors and irregularities using statistical means? I think so, yes. And only then do I see the processing transformed digitally.

And so, even established companies have to expect that their rigid sales/service routines will be replaced by completely different processes in the newly established competitors, that they will be overtaken by the competition, in a surprising way, so to speak, previously assumed to be unthinkable or unlawful. To put it vividly,”at excessive speed” or “on a forbidden track”… and that, in my opinion, is the real meaning of digital transformation: there are new players/competitors and the “cheat/trick” because they don’t adhere to the usual mechanisms and surprise everyone:

  • … there is someone who runs the 100 meters at the World Cup with a short cut and wins – this is only unthinkable, not yet happened but not explicitly forbidden in the rules?
  • …. or jumps under the crossbar and wins – there was something once? Right: > Dick Fosbury 1968 at the Olympic Games in Mexico.

The competitors of the > straddle style were unfortunately no longer satisfied with the tried and tested methods “sifting of the best talents, hiring the best trainers and organising the best training camps”.

The solution-invariant customer problem

The Fosbury-Flop has efficiency advantages, because the centre of gravity during the jump curve is always below the high jump batten to be crossed by the body. This corresponds to the “solution variants (customer) problem”.

This is exactly the view you as a company must have of customer problems. In other words, check your products, services and solutions in the digital environment to see whether similar (previously unthinkable) advantages in business processes can be made visible and usable in the future by networking, IoT, Big Data and KI/ML.

For example, are you a manufacturer of measuring instruments? Your customers don’t really want to buy or own any measuring devices. They only need them to check their production facilities and the quality of the manufactured products. Another process (for an exemplary simple case) could be to use the motion/vibration sensor of a mobile phone to record the resonances/oscillations of the production plant. The digitization would be accomplished and they would have the “digital twin” of the required data. These could now be compared with large quantities of known characteristic curves of intact and faulty plants (e. g. in the cloud at a service provider) of an AI. This would have involved a change from the acquisition/ownership of products to the results service.

There are similar ideas among the major automobile manufacturers who are pursuing a move away from the “owning a vehicle” model towards “mobility solutions”. It is only such changes of processes and business processes that I would like to call “digital transformation”.

Your Digital Transformation

Finally, I would like to point out the need for action in view of the possible disruptive developments. Examples such as Uber and AirBnB have shown that it is not enough to keep ahead of well-known competitors. You have to face completely new competitors and offers that can appear very fast, surprising and dominating.

Test your digital maturity level, make a workshop on new ideas/procedures and their implementation with your IT. Be ready for your own digital transformation and feel prepared for the new approaches of your competitors. We will be happy to support you!