Modernization, Transformation and Data Migration with Steve Gens

Modernization, Transformation and Data Migration with Steve Gens

by | Jan 30, 2025 | Digital Transformation, ECM, Life Sciences, Migration Services

This month, fme’s President Frank D’Entrone joined the Regulatory Executive Podcast with Steve Gens. We’ve worked with Steve for many years and have been recognized in Gens & Associates industry studies as a leader in the migration services provider category. Listen to the Gens & Associates Regulatory Executive Podcast >>

Listen to the Podcast

Frank was honored to be invited to sit down to discuss the trends and challenges of modernizing large RIM, Quality and Clinical systems, and how to plan an efficient, accurate and compliant data migration. From our experience with clients from small pharmaceuticals up to the Top 20 firms, many start a modernization or transformation initiative without a clear understanding of the quality and state of their existing data and documents. This is a critical phase of any migration that should not be skipped or minimized. Done correctly, it can have a powerful influence on the success of the transformation initiative by revealing the level of data remediation required, how much can be automated, and how much requires human involvement.

We highly recommend you take the time to listen to Frank and Steve’s discussion. They cover:

  • fme’s history, reputation and focus
  • Importance of data remediation in a migration initiative
  • Value of a ‘Phase 0’ focused on evaluating existing data and documents
  • Proven and evolving automation tools like AI
  • Industry trends and challenges
  • fme’s future vision

The Bottom Line on Data Migrations and Digital Transformations

The bottom line is today’s advanced digital tools – traditional, AI-powered, or otherwise – all depend on organized, accessible and compliant data. After almost 30 years of experience, fme understands how to apply our proven methodologies and migration tools with evolving AI and NLM capabilities for successful migrations, ensuring our clients get the most ROI from their technology investment. Regardless of source and target systems, fme’s experts know the most effective ways to clearly define the system’s current state and help client’s plan an efficient path into the future. Contact us to get started.

We hope you find Frank and Steve’s discussion enlightening and useful. If after listening you have any questions or comments you’d like to share, send us a message – we’d love to get your perspective, and learn more about your current challenges.

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Pre-plan Your Regulatory Transformation Projects for 2024

Pre-plan Your Regulatory Transformation Projects for 2024

by | Nov 27, 2023 | Digital Transformation, Life Sciences, Technology Services

From building a realistic AI roadmap to making better choices about technology partners and broadening the impact of RIM systems, fme’s consulting approach and specialist data services can help pharma, biotech, and medical devices companies maximize investment into their digital transformation journey – both now and in the future.

It can be hard to effectively prioritize an ambitious digital transformation journey when external requirements and technology-based systems keep evolving. In a Life Sciences Regulatory context, those moveable parameters include changes dictated by compliance with IDMP data standards, or unique device identification (UDI) in the case of medical device manufacturers. Other influences might take the form of company mergers or acquisitions that require system consolidation or data harmonization, taking advantage of the continuous changes in evolving technology, or new opportunities to transform processes linked to the Regulatory functionality.

To successfully prioritize next steps and set realistic budgets that align with business goals, it’s important to consider the overall digitalization and transformation company roadmap.

We suggest reviewing these 3 considerations in particular when firming up plans for 2024.

Your roadmap for AI

Everyone is talking about artificial intelligence (AI) and machine learning (ML) as the technology becomes more advanced and accessible for mainstream day to day use. Certainly, it carries enormous potential to save time and drive new process efficiency, consistency, and repeatability. But there are use cases that lend themselves to AI/ML-based transformation, and others that do not, and it’s important to have a clear understanding of both the opportunities and the potential risks.

For instance, Generative AI (assistants like ChatGPT) could be ideal for drawing up job descriptions, summarizing recent achievements for a report or blog article, and/or improving communication across your organization (e.g. keeping everybody up to speed with the progress of a Regulatory Information Management implementation project). But such tools could incur substantial risk if used to generate patient information leaflets.

fme’s technology and content specialists can help you develop an appropriate strategy for your AI journey. Also, we can help you evaluate the current technology landscape – e.g. Regulatory Information Management (RIM) providers or other content management providers.

Get more out of your RIM system

Investing in a RIM system is a strategic move for organizations, with its significance extending beyond the immediate regulatory function. The true value of RIM platforms emerges when they transcend mere content collation and agency submission management.

The potency and transformative impact of a RIM platform become apparent when it delivers rich and comprehensive knowledge, making it accessible across the entire organization. When Regulatory, Quality, and Safety information is holistically stored and managed, strategic teams gain the ability to construct a nuanced understanding of market trends, identify adverse events, and pinpoint gaps in market coverage.

Elevating visibility beyond individual silos is a game-changer, providing C-level executives with a holistic view of organizational dynamics. This comprehensive perspective empowers executives to make informed decisions swiftly, expediting the process of bringing products to market.

Realizing the broader benefits of a RIM platform necessitates the formulation of a clear yet flexible digitization roadmap. Building on a sound data ‘bedrock’ is critical, establishing the right infrastructure and software platform to support smart, digitized information use and process efficiency. This foundation enables strategic compliance with evolving regulations and creates room for targeted adoption of AI and other technological advancements, ensuring the system’s relevance and value for at least the next five years.

Whether the strategic goal involves improved high-level decision support or leveraging Generative AI for routine, low-risk content creation, trust is paramount. Professionals must have confidence in the validity, quality, currency, completeness, and consistency of the information harnessed from the RIM system to effectively drive organizational goals.

Understand what you need from your RIM system and technology partner

Every RIM and content management solution, and technology partner, has its own features and benefits, and selecting the right fit will depend on the size and complexity of your organization as well as your future business goals.

Consider the following: As a pharma company, you don’t produce all the chemicals and machinery that go into the production of a drug. You select and assemble the best components to produce and deliver your product in the most cost-effective way. It’s the same for your technology solutions and partners. Should you expect a single vendor to provide a complete end-to-end solution that amazingly fits your unique needs when procuring a technology platform? No. It’s far more effective to define your requirements, and find technology and partners with their own capabilities, strengths, and experience that aligns with your needs, and all the vendors to concentrate on delivering a solution that is compliant with all regulatory requirements. Your technology vendor shouldn’t have to provide data assessment and migration services, a unique set of skills that are available from skilled specialists.

It’s critical to evaluate potential new technology and partners and understand what qualities you need in the full scope of the project including initial business process and data analysis, implementation and integration, data migration, and post-implementation support. Many decision-makers are swayed by a vendor that appears to offer a full end-to-end solution and services that seem to be packaged with all the associated services. But if those services are all designed around that company’s own product, how can they be sure they’re getting unbiased advice for a futureproof investment? That is an exceptional level of trust for such a large and business critical investment.

Instead of choosing a platform provider based on the promise of an end-to-end service, strategic companies choose knowledgeable and certified technology partners that are 100% focused on their unique business challenges and vision.

As an independent service provider, fme doesn’t have a vested interest in recommending any particular RIM or content management vendor or platform. fme’s consultative approach, specialist data services, and proven tools are designed to optimize the selection, delivery, and output of the system of choice. With proven strategies, fme helps companies navigate the complex minefield of vendors and technology options. Not only do we clarify and define your unique requirements, we have extensive experience with all the leading RIM platforms, along with deep insights into where these fit best relative to the type and size of the organization and its specific priorities. We help companies select and implement solutions that fit their needs in the short- and long-term, solving today’s challenges, manage and maintain those solutions as they grow, and establish a pathway for continual improvement as technology evolves.

Conclusion

Whatever your digitization objectives, fme’s business, technology, and content experts can help you assess and maximize the ROI of your plans. Whether you are planning a stand-alone project or incorporating an initiative within the context of other ongoing projects, fme can help you align your business strategy, technology, and priorities with your available resources, as well as platform vendors’ respective product roadmaps.

To discuss or analyze a current RIM project or transformation requirement, contact us. We’d love to learn your challenges and provide an independent perspective designed to amplify your business success.

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AI Takes the Spotlight at OpenText World 2023

AI Takes the Spotlight at OpenText World 2023

by | Oct 15, 2023 | Digital Transformation, OpenText

Alright, let’s talk about the buzz that’s been going around after OpenText World 2023 in Vegas. First off, OpenText made a bold move by switching their domain to opentext.ai. It’s not just a name change; it’s a statement that screams, “We’re all in on AI!”

The Game Changers: Generative AI and LLMs

Now, what’s getting everyone talking is the power of Generative AI and those nifty Large Language Models (LLMs). Imagine being able to pull content from anywhere, structured or unstructured, and then getting precise answers to your burning questions. For those of us who’ve been in the game for a while, finding the right info has always been a bit of a chase. But with LLMs, and the new tools by OpenText or tools like fmeGPT, it’s like having a secret weapon that just gets context and produces relevant content to the user this way.

Chatting with your Data? It’s Happening.

Think about this: soon, we’ll be having smooth, ChatGPT-like conversations with our corporate data. It’s not just about asking a question and getting an answer; it’s about doing so securely. And speaking of secure and innovative approaches, that’s exactly where opentext’s new tool sets and solutions like fmeGPT shine. Integrating such technology can genuinely revolutionize how you interact with your organization’s data. OpenText demoed this impressively many times during the conference.

But hey, all the AI in the world won’t help if your data’s a mess. You’ve got to have a solid foundation. You need that sweet spot of great information and automation management. And if you’re wondering where to start, OpenText, with its array of tools and platforms, might just be your answer.

AI’s Next Move: Doing the Heavy Lifting

Here’s the exciting part: AI is gearing up to do a lot more than just answer questions. We’re talking full-blown automation of processes with just a dash of human touch when it really counts. This is where Artificial Capable Intelligence (ACI) steps in. If you’re looking for some deeper dive reading on this, check out Mustafa Suleyman’s “The Coming Wave”. It paints a picture of AI handling everything from making decisions to sealing deals.

Picture this: An AI that can pick products for drop shipping, negotiate contracts, set up an online store, run marketing campaigns, take orders, handle payments, and ship products. No need for a ton of meetings or back-and-forths. Sounds like the future, right? Well, it’s closer than we might think.

In a nutshell, OpenText World 2023 was more than just a conference; it was a glimpse into a future where AI isn’t just a tool—it’s a game changer. Time to get on board & contact me!

The Time Has Come to Replace Documentum Webtop

The Time Has Come to Replace Documentum Webtop

by | Sep 19, 2023 | Digital Transformation, Documentum, ECM, OpenText

 poaIn the world of Enterprise Content Management (ECM), OpenText Documentum has been a popular choice for organizations seeking a robust and scalable solution. Webtop has been the primary interface to leverage the power and flexibility of Documentum, and for many years it has served this purpose very well. However, technology advances and user expectations evolve. Just like our phones, it’s critical to reevaluate the tools we rely on to maintain productivity and efficiency. In this blog post, we will delve into the reasons why it’s time to replace OpenText Documentum Webtop and to explore alternative options that can better meet the needs of modern businesses.

Outdated user interface (UI)

Webtop was originally designed more than a decade ago, and its interface is highly reminiscent of that era. The design came from a “more-is-better” time, trying to incorporate every possible functionality into the UI, overloading the client with options that are not relevant for the majority of end users. The flow, usability and reactiveness of the client UI are outdated, not intuitive and “fun” to work with, and do not meet today’s expectations, making it difficult for users to effectively interact with the application. In an age where user experience is paramount, it’s crucial to take advantage of well planned, modern, and user-friendly interfaces that are targeted to support efficiency in the daily work.

Lack of mobile compatibility

In today’s mobile-first world, employees increasingly rely on smartphones and tablets to access information and collaborate on the go. Unfortunately, OpenText Documentum Webtop does not offer a seamless mobile experience. Its interface is not optimized for smaller screens, making it veritably unusable for mobile colleagues. By replacing Webtop with a mobile-friendly solution, organizations can provide device and location flexibility required by today’s environments and empower their workforce to access and contribute to their content from anywhere, at any time.

Limited collaboration capabilities

While one of the flagship capabilities of OpenText Documentum Webtop is locking documents to ensure sequential editing without overwriting previous versions, this approach limits the potential for real-time collaboration. As we all know, collaboration lies at the heart of efficient and effective content management. In today’s business world, it is common to share documents across teams and work in parallel to contribute, review and approve. This is extremely challenging using Webtop’s technology. Interfacing seamlessly with MS Office 365, allowing collaborative work in parallel and even simultaneously, is expected nowadays. Modern ECM clients offer these advanced collaboration features enabling seamless teamwork and boosting productivity.

Documentum Webtop’s integration challenges

As businesses grow and diversify their technology stack, integration becomes crucial for seamless workflows. OpenText Documentum Webtop’s integration capabilities are often complex and time-consuming. It lacks – nowadays common – out-of-the-box integrations with popular tools, making it difficult, and therefore expensive, to connect with other critical business applications. By upgrading to solutions empowered with modern integration capability, organizations can benefit from predefined, seamless integrations with various systems, streamlining processes and increasing efficiency.

Limited scalability and maintainability

In today’s dynamic business landscape, scalability and easy maintenance are essential. OpenText Documentum Webtop’s architecture and design create several issues:

  • It is challenging to scale up or down to meet changing business needs.
  • Documentum Webtop’s implementation model only allows for a small level of configurations; the majority of application adjustments are made through customizations and code changes.
  • Implementing new releases or additional requirements can be a time consuming and expensive task.

According to OpenText, Documentum Webtop has reached an application stage where no further product enhancements are being provided – the focus is now merely on keeping the application framework running with modern, more secure, Java and browser versions. As organizations expand, through organic growth or acquisitions, or undergo digital transformations, they require a proven business application platform that can easily adapt and grow alongside them, and that can be easily maintained. This capability is required to ensure scalability and future-proof their content management strategy.

Next steps: Going beyond Documentum Webtop

As the leading solution for many, many years, we should thank OpenText Documentum Webtop for the long and fruitful journey! It has certainly served us well, but it’s time to acknowledge that the time has come to get the advantages of upgraded alternatives. Today’s solutions provide a modern user interface, mobile compatibility, advanced collaboration capabilities, seamless integrations, and high scalability and maintainability. With these features, businesses can unlock new possibilities for content management, boost productivity and efficiency, and stay ahead in today’s fast-paced digital world. It’s time to bid farewell to Webtop and embrace the journey to a new era of content management excellence.

To learn more about what options are available beyond Webtop to increase the accessibility and value of your content contact our fme team. As long-time Documentum partners, we have over 1,200 combined person-years experience with the full range of OpenText solutions. We’d love to help you get the most from your existing content library, and prepare your business to get the advantages in technology’s exciting future.

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Executive Perspective: Generative AI, it’s about to change EVERYTHING

Executive Perspective: Generative AI, it’s about to change EVERYTHING

by | Sep 14, 2023 | Digital Transformation

Via secure company-wide intranets that draw on Microsoft’s Azure OpenAI, to intelligent bot-enabled business functions and regulatory processes, ChatGPT and tools like it are going to transform the way entire organizations access, collate and distribute knowledge, and create new assets – and what they do with all of it. As a specialist in data and content management in regulated industries, fme is already on the case with strategic advice, roadmap development, and customer prototypes.

To say that artificial intelligence, and specifically Generative AI, is poised to transform IT delivery as well as a whole host of other corporate functions, is no exaggeration. It is already happening, and it is going to be at least as transformational and disruptive as the World Wide Web or the cloud – which means that corporate executive teams should actively investigate the possibilities sooner rather than later.
At fme, we’re already involved in a client pilot project which will transform that company’s knowledge distribution and access. By first scrutinizing and cleaning up, then migrating content to a secure, cloud-based intranet harnessing Microsoft’s Azure OpenAI, we’re working with the organization (an industrial manufacturer) to make all of its knowledge and content assets securely searchable and collatable – using GPT4 from Open AI as the main engine.

This will have a bearing on the way that new employees find answers to almost any query, while practically eliminating the time knowledge workers spend each day trying to locate the latest information or documents they need on almost any topic (limited only by role-related access rights/privacy settings). If staff need a summary of all the latest regulations they must adhere to for a given task, or need to pull together the latest findings on a particular topic, they can simply ask the question and let the technology do the legwork – presenting the information back to them in a meaningful, context-appropriate way.

Quickly, over time, the returned answers will improve too – because users will have the facility to rate them with a quick thumbs up, or thumbs down, as feedback on the accuracy, relevance and usefulness of the delivered search results/collated content.

Trust us: we’re tracking the latest developments

This is a glimpse into next-generation content and data management, and it’s at the forefront of fme’s vision – spanning our business/strategy consulting, and our integration, data cleansing/preparation/enrichment, and content migration services.
It’s all about taking the long-term view. For now, the immediate preoccupations for regulated organizations including Life Sciences companies, industrial manufacturers, and finance institutions might have more to do with reducing dependency on legacy systems; consolidating content following a merger; or becoming more responsive to regulatory changes.

Usually, however, these initiatives are ultimately about being better at information, content, and knowledge management. This has been the focus of my career – and of fme – for the last 25+ years. And in the not-too-distant future, transformed data, content, and knowledge management will involve Generative AI as both the enabler and the intuitive user interface.

Culture change requires long-term Board-level buy-in

Even a year ago, no one could have predicted how rapidly Generative AI would take hold and grow in its application. Accepting and fully embracing the implications is going to require significant culture change for companies, an organizational transformation that can take many, many years to see through – not to mention a considerable amount of blood, sweat and tears. Given that the typical tenure of a CEO is 4-5 years, organizations must now infuse the entire Board with a vision and appetite for Generative AI’s potential across their operations.
Beyond information and content management and analytics, we suggest that the next level of Generative AI application will be in transforming core processes – from HR, sales, creative marketing, and finance management, to IT development, and web site creation (think: “Please generate a web site that does X”). Then, as the technology matures, and trust builds, regulated areas such as Regulatory Information

Management will become a valid area of focus.

If there’s one message I want to get across, it’s that AI – and Generative AI specifically – is here to stay, and it will change the world. Its presence is already prominent, and its potential reach is all-pervasive.

The focus shouldn’t be about developing a separate AI strategy, or even updating the organization’s digital transformation strategy. It should be about weaving Generative AI, and indeed any other aspect of digital transformation, into an organization’s core business strategy – and establishing where the technology could and should be harnessed to help deliver this.

Human factors: everyone will benefit; no one will be unaffected

As to the impact of Generative AI on the role of humans, undoubtedly this will be significant. While human expertise will remain vital in checking, feeding back, refining and improving/embellishing AI’s findings, in time the size of IT/Web development teams, HR functions, finance teams, and so on will inevitably reduce. That’s as more of the groundwork is covered by intelligent technology.

It isn’t just the search and filter intelligence that’s transformative in all of this, after all. It’s the user experience. At fme, we are partnering with a design agency in Berlin for this, recognizing that the way individuals engage and interact with an application or tool is at least as importance as the clever things it can do. And we’re as serious about that whether it’s for our middleware or IT admin tools, or a more advanced stack of content enrichment and management capabilities.

There are all kinds of other trends affecting companies’ use of IT, of course – from continued remote and mobile working enablement, in the wake of Covid; to budget-friendly off- and near-shore resourcing to overcome local talent gaps; to reinforced security and resilience in the wake of Russia’s invasion of Ukraine and renewed concerns about cyber-attacks bringing down IT services.

Our priority in all of this is to keep looking ahead and anticipating what it is that our clients not only require today, but also what they will ultimately need to do, in 3-5 years; and to keep innovating with optimized strategy consulting and specialist IT services that will deliver those priorities in plenty of time.

To find out more about any of our strategy consulting or IT services, or to discuss the potential of Generative AI in your organization’s knowledge management or core process transformation, contact us. We’d be happy to set up a time with you and our experts to determine how these new technologies can benefit your business.

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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.