Belgium may be a small country, but it has an unusually strong footprint in European clinical research.

Its ecosystem combines university hospitals, specialised research centres, experienced investigators,
pharmaceutical companies and public authorities with extensive clinical research expertise. Belgium has
maintained a leading European position in clinical trials for years, supported by a dense network of
research institutions and life sciences expertise.

For pharmaceutical and biotech companies conducting Phase IV studies, post-marketing research or
real-world evidence projects in Belgium, however, the quality of the scientific protocol is only part of the
equation.

Execution is local.

Hospital processes are local. Investigator relationships are local. Patient pathways are local. And although
European regulation provides a common framework, understanding how research operates in practice
within Belgium can make a significant difference.

This is where working with a local CRO in Belgium can add value.

Belgium continues to actively strengthen its clinical research environment.
According to the Belgian Federal Agency for Medicines and Health Products (FAMHP), 289 clinical trials received full approval without conditions in 2025, compared with 225 the previous year. Approximately 30% of Belgian clinical trials in 2025 focused on cancer therapies.

Belgian authorities have also introduced accelerated assessment timelines from January 2026 for initial mononational clinical trial applications, including measures covering Phase II through Phase IV studies. This illustrates something important for sponsors.
Belgium is not simply a market in which clinical research takes place. It has a mature and continuously evolving clinical research infrastructure.Taking advantage of that environment requires more than translating a European study strategy into a
Belgian protocol.

It requires local operational knowledge.

A local Clinical Research Organization combines clinical research expertise with an understanding of how studies are executed within the Belgian healthcare ecosystem.

For late-phase and post-marketing research, that can be particularly relevant.

1. Better understanding of the Belgian regulatory environment

Clinical trials in Belgium operate within the European Clinical Trials Regulation and the Clinical Trials Information System, alongside Belgian regulatory and ethics requirements. The FAMHP maintains specific national procedures, timelines and guidance for sponsors conducting research in Belgium.

A local CRO is therefore positioned close to both the European regulatory framework and its practical Belgian implementation.

For sponsors, this can help reduce avoidable friction around submissions, documentation, ethics processes and study start-up.

2. Closer relationships with Belgian study sites and HCPs

One of Belgium’s key strengths is its network of university hospitals, research institutions and experienced investigators.

But identifying a site is not the same as successfully activating and managing it.

Late-phase studies often require close coordination with investigators and healthcare professionals throughout the project.

A CRO with an established presence in Belgium can support:

• study-site identification and feasibility
• investigator and HCP engagement
• site onboarding
• study coordination
• monitoring and follow-up
• operational issue resolution
• communication between sponsors and local stakeholders

For smaller national studies in particular, proximity can become an operational advantage.

3. Understanding how Belgian healthcare works in real life

Real-world research is, by definition, connected to routine healthcare.

That means understanding the environment in which patients are actually treated.

Care pathways, referral patterns, hospital structures, language requirements and interactions between healthcare stakeholders differ between markets.

Belgium adds another layer of complexity because clinical projects may involve Dutch-speaking, French-speaking and sometimes multilingual stakeholders.

A local CRO can help a sponsor design an operational model that makes sense not only scientifically, but also within Belgian clinical practice.

A Phase IV study takes place after a medicinal product has been authorised and may address questions that
become particularly relevant once the treatment is used in broader clinical practice.

• These can include:
• long-term safety
• treatment effectiveness in routine practice
• patient adherence and persistence
• treatment patterns
• patient-reported outcomes
• healthcare resource utilisation
• specific patient populations
• post-authorisation safety questions

Real-world data are also becoming increasingly relevant within the European regulatory environment. The EMA actively uses real-world evidence alongside other evidence sources and operates DARWIN EU to support the generation of RWE for regulatory decision-making.

The question for pharmaceutical companies is therefore no longer simply:
“How do we complete our post-marketing study?”
A more strategic question is:
“What can we learn from the way our treatment performs in Belgian clinical practice?”

Large international CROs bring obvious strengths to large multinational development programmes.

But bigger is not automatically better for every study.

For a Belgian Phase IV study, observational study or focused real-world evidence project, sponsors may
need something different:

accessibility, flexibility and local ownership.

Instead of adding another coordination layer between the sponsor, international project team and Belgian sites, a local CRO can work closer to the stakeholders actually executing the study.

This becomes particularly relevant when:

• Belgium is a strategic market rather than one country among dozens
• the study involves a limited number of specialised sites
• strong investigator engagement is required
• the protocol needs to reflect Belgian clinical practice
• local monitoring is important
• the sponsor needs rapid operational communication
• the project involves real-world data or patient-reported outcomes
• the study is post-marketing or Phase IV

The right CRO model should therefore depend on the study, rather than on the size of the supplier

Local does not mean less rigorous.

Clinical research in Europe must comply with demanding standards for patient protection, data integrity and study quality.
ICH E6(R3), the current Good Clinical Practice guideline in the EU since 23 July 2025, reinforces a quality-bydesign and risk-proportionate approach to clinical research.

This is an important distinction when evaluating a local CRO.

Sponsors should look for a partner capable of combining local agility with international standards of clinical quality.

Questions worth asking include:

• How is study quality managed?
• How are monitoring activities organised?
• How is sponsor oversight facilitated?
• How are study risks identified and followed?
• How are clinical data managed?
• How are regulatory and ethics interactions handled?
• Does the CRO understand both GCP and the realities of local study execution?

Local knowledge creates value only when it is supported by robust clinical processes.

Novellas Healthcare specialises in Phase IV, post-marketing and real-world clinical research in Belgium and the Netherlands.

With more than 25 years of experience in life sciences, Novellas combines clinical, medical, regulatory and data capabilities with a strong understanding of the Belgian healthcare environment.

Its CRO capabilities include:

• study design and protocol development
• regulatory submissions and ethics committee coordination
• site selection and investigator coordination
• clinical monitoring
• study reporting and compliance follow-up
• clinical data management
• biostatistics
• real-world data collection
• real-world evidence analysis
• patient-reported outcomes
• scientific communication

The objective is not to replicate the model of a global CRO.
It is to provide pharmaceutical, biotech and medtech companies with a specialised local partner capable
of taking ownership of clinical research projects in Belgium.

For many sponsors, choosing a CRO ultimately comes down to confidence.

• Confidence that sites will be supported.
• Confidence that local requirements are understood.
• Confidence that issues will reach the right person quickly.
• Confidence that the study will generate data that are scientifically valuable and operationally reliable.

For a Belgian late-phase study, having the project team close to the market can therefore be more than a
practical advantage.

It can become part of the study strategy

Belgium offers an exceptional environment for clinical research.
But benefiting from that environment requires an understanding of what happens beyond the protocol.

The sites. The investigators. The healthcare system. The regulatory processes. And ultimately, the
patients behind the data.

That is where local expertise matters.

If you are preparing a Phase IV study, post-marketing project or real-world evidence initiative in
Belgium, Novellas Healthcare can support the project from study design to execution, monitoring, data
management and analysis.

Discuss your next Belgian clinical research project with Novellas Healthcare.