Stringent audits, validated systems, and absolute security form the baseline of the Life Sciences sector. That same sector is now under increasing pressure to innovate, adopt AI and embrace digital technologies. To address this, fragmented solutions will not be enough: regulatory compliance, data streams, and core operations need to adapt as a unified whole to protect patient and system safety.
That is the problem Reshaping Life Sciences aims to solve: a new framework from Sopra Steria built around three ambitions — Compliant, Connected and Intelligent — and five digital themes. It’s designed to help Life Sciences organisations adapt faster, operate more effectively, and innovate with confidence. To explain what that means in practice, we spoke with three of the people shaping it: Moustafa El Jalti, Deputy Market Director Industry, and Niels Verherstraeten and Niels Raymenants, both Director Life Sciences at Sopra Steria.
Strong growth, tough competition
The starting point for the conversation is a paradox. The global medicines market is expected to keep growing strongly through 2030, and areas such as oncology are growing even faster than the market as a whole. For an industry built on long R&D cycles and strict regulation, that is good news.
But growth of the market and growth of any individual organisation are two different things. “The market is growing, but competing in that market is becoming more difficult,” says Niels Raymenants. The US is becoming more assertive on pricing, regulatory policy and domestic manufacturing, all of which now weigh directly on market access. China too is becoming a real source of biotech innovation and licensing deals. A wave of patent expiries is pushing large pharmaceutical companies toward partnerships, licensing and acquisitions to keep their pipelines full. Geopolitics plays a role too: tariffs, supply dependencies, and decisions about where to manufacture, source and invest next.
“The environment in which companies have to make investment decisions is far more complex than it was a few years ago,” says Niels R. That complexity plays out differently from one region to another. Belgium, for instance, still ranks among Europe’s strongest biopharma and clinical-research hubs, though even there, recent figures show growth is no longer guaranteed.
Niels Verherstraeten puts the underlying message plainly: “A strong Life Sciences sector today doesn’t guarantee a strong Life Sciences sector tomorrow. Investment can move. R&D can move. Manufacturing can move. Organisations need to keep innovating and build more resilient operating models, without losing what makes this sector different: quality, evidence, patient safety and trust.” That is precisely the tension Reshaping Life Sciences is designed to address.
A strong Life Sciences base today doesn't guarantee a strong Life Sciences base tomorrow.
Niels Verherstraeten
Three ambitions, one foundation
Staying ahead of that pressure starts with three basic pillars, which form the foundation of a future-proof Life Sciences organisation: compliant, connected, intelligent.
“Compliant means being able to innovate without compromising quality, patient safety, data integrity or regulatory requirements, from data integrity rules such as Annex 11 to newer frameworks like the EU AI Act,” says Niels V. “Connected means getting people, processes, systems and data to work together across the value chain, instead of operating in silos. And Intelligent means using trusted data, AI and automation to make better decisions, improve performance and accelerate innovation.”
The three are not separate programmes, but reinforce each other. That becomes clear as soon as a client conversation starts. “A client question often sounds specific when it starts, but it becomes broader quite quickly,” says Niels R. “A client says, ‘we want to scale GenAI.’ Then you immediately get questions about data ownership, security, validation, human oversight, adoption and value. Or they want to modernise a supply-chain or manufacturing platform, and that becomes a conversation about planning, quality, integration, data, cyber and change.” Compliant, Connected and Intelligent works because it stops the first technology question from being treated as the whole problem. It keeps the business outcome in view.
Moustafa frames it as a simple test. “The three pillars give us a way to check whether we’ve actually solved the client’s problem, not just the technology part of it,” he says. “Across the different industries we work with, I see the same mistake: we solve the technology layer and assume the value will follow. But can the process actually work differently? Are people ready to use it? Is ownership clear? Is the data trusted? Can it scale? And in Life Sciences, can it operate safely in a regulated environment? The three pillars that form the red thread in our Reshaping Life Sciences story, give us a common language for that conversation, without starting from a product or a platform.”
Five themes, one connected engine
The three pillars are supported by five digital themes: Strategy & Transformation, Quality & Compliance, Data & GenAI, Enterprise & Supply Chain, and Cyber Resilience. Treated as five separate service lines, they risk becoming exactly that: five boxes on a slide.
“But the client does not experience digital transformation in boxes,” Moustafa says. “They want to improve time to market, modernise manufacturing, improve supply reliability, scale AI, increase productivity, simplify an operating model… You start from that outcome, and then you ask which capabilities need to come together.”
In digital transformation, you start from the outcome, and then you ask which capabilities need to come together.
Moustafa El Jalti
Niels R. makes that concrete with an example. “Strategy & Transformation defines what we are actually trying to improve, and what the target operating model should look like,” he says. “Enterprise & Supply Chain connects planning, procurement, production, quality, warehousing and distribution. Data & GenAI can support forecasting, knowledge and faster decision-making. Quality & Compliance ensures the new process and systems can operate in a GxP environment. And Cyber Resilience protects the connected environment you are creating.”
If those five conversations happen independently, he adds, the client ends up having to integrate everything later. “Bring the right experts together from the start, and you avoid the rework later.”
That kind of connection is already happening for Sopra Steria customers. “One example is a global Life Sciences manufacturer facing a challenge getting AI adopted across the organisation,” says Moustafa. “From Strategy & Transformation, we give strategic advice on AI governance, AI adoption and operating models. From Data & GenAI, we bring the applied side: agentic workflows, bots, robotic process automation, intelligent automation... That is how our digital themes translate into practice: Strategy & Transformation and Data & GenAI come together around the same client challenge. Rather than approaching AI adoption as a standalone technology question, we connect the expertise needed to address governance, ways of working, user adoption and implementation”.
Quality & Compliance, in particular, remains central even as the story broadens. “It is one of the reasons many clients trust us in the first place,” says Niels V. “What changes with our Reshaping Life Sciences initiative is that we connect that strength to the other domains much earlier. Quality becomes part of the transformation design, instead of a separate checkpoint at the end.”
A transformation partner, built on Life Sciences expertise
A lot of organisations can say they offer AI, cybersecurity, ERP or digital transformation services. What makes Sopra Steria genuinely positioned to bring these five themes together for Life Sciences clients specifically?
Part of the answer is history. “We already have deep Life Sciences credibility,” says Niels R. “With several of our Life Sciences clients, that trust was built through Quality & Compliance and other regulated services. What’s changing is the scope of the conversation. Clients now ask us to think with them about AI industrialisation, data, enterprise transformation, supply chain and cyber, not compliance alone.” Reshaping Life Sciences, he says, reflects that shift: starting from the client’s challenge, then bringing the right expertise to it, across all five themes rather than one at a time.
“Sopra Steria has deep Life Sciences credibility. That trust was built through Quality & Compliance and other regulated services.
Niels Raymenants
The other part of the answer is scale and breadth. Sopra Steria has 250+ people already active in Life Sciences, including 100+ deep GxP specialists, with access to the wider capabilities and scale of a 51,000+ person European technology group.“We have people working on major manufacturing transformations, enterprise platforms, data, cyber, cloud and operating models in other regulated and asset-intensive industries,” says Moustafa. “That gives us direct experience with many of the transformation patterns our Life Sciences clients are now facing.” Moustafa is careful to frame this correctly: “The point is not to copy a solution from another industry into pharma. That would be too simple. Instead, we bring the relevant lessons, combine them with genuine Life Sciences expertise, and build the answer together.”
Sopra Steria’s Life Sciences expertise shows clearly in two recent initiatives. Themis, an AI-driven platform built at the intersection of Quality & Compliance and Data & GenAI, automates the repetitive parts of GxP audit trail review: extracting review rules from SOPs and regulations, flagging anomalies, and drafting reports, while a qualified reviewer checks every flag and gives final sign-off.
Alongside it, the GxP Academy transfers practical GxP expertise across Sopra Steria, so specialists in any role — a developer, a project manager, a domain expert — understand and apply regulatory requirements in their own work.
"It's not only technology," says Moustafa. "It is about transferring knowledge, and bringing people, process and technology together."
Two current challenges: AI adoption and data control
Two current pressures show just how much the three pillars matter in practice.
The first is artificial intelligence. “Life Sciences organisations already use AI,” says Moustafa. “Mostly, it’s shadow AI: personal chatbots used for all kinds of tasks, without much visibility into what data goes into them. That layer is enormous, and it is consistently underestimated.”
It also slows down the enterprise-grade AI initiatives organisations try to build later, because people who already have a workflow that works well have little reason to switch to a company tool they'd need to learn from scratch. That resistance is often mistaken for resistance to AI itself. It's not. Instead, employees face the cost of unlearning an existing habit.
Moustafa's answer is not a blanket ban on experimentation. It is to give people a safe, governed way to experiment, with clear boundaries on approved tools, data and responsibilities. “Every department needs room to experiment. But the organisation also needs visibility into what is running, and at what risk level.” Done well, Moustafa argues, that governance becomes a competitive edge in itself: organisations that can scale AI safely move faster than those still firefighting Shadow AI risks.
The second challenge is data sovereignty. “We used to see that it didn’t matter much to clients where their data was stored,” says Niels V. “That has changed. Clients are more aware of the wider geopolitical picture, and some are now asking whether they should move data back on-premise, simply to keep more direct control over something this sensitive.”
One recent example: a pharmaceutical client asked Sopra Steria to help bring its data back within its home country’s borders. Niels R. sees it as part of a longer shift between models: “Years ago, everything was on-premise. Then came the big shift to cloud. Now clients are thinking again about a hybrid model, because dependence on a small number of large providers no longer feels risk-free.” Sopra Steria has responded by expanding its options, investing in sovereign European partnerships, such as Mistral AI and OVHcloud, alongside its existing hyperscaler partnerships.
What does a reshaped organisation actually look like? Niels V. paints the picture: "Data flows seamlessly across functions instead of sitting in silos. Decisions are backed by trusted data and AI, not gut feeling. Compliance is built into processes from day one, not bolted on at the end. And the organisation can adapt quickly, because governance, quality and security move with the business instead of trailing behind it."
The way forward for Life Sciences organisations
Asked what a Life Sciences leader should remember from all of this, each of the three offers a different angle.
“Do not treat compliance as something that comes after innovation,” says Niels V. "Build trust, quality and control into the way you innovate from the start.”
“Do not assume market growth will automatically become your growth,” adds Niels R. “Start from the business outcomes that will make you more competitive, and then connect the right capabilities across R&D, data, manufacturing, supply chain, quality and people to achieve them.”
Moustafa closes with the idea that connects everything above. “Start with the business outcome, not the technology. Then bring together the right expertise needed to change how the organisation works—from strategy and design through implementation and adoption. That’s what Reshaping Life Sciences is about: helping organisations innovate and adapt faster, while staying Compliant, Connected and Intelligent, with five digital themes working as one connected engine. Not five separate offers, but one conversation around the client’s transformation.”