Your Phase IV CRO partner in Belgium & the Netherlands

Post-marketing data is no longer a regulatory checkbox: it’s a strategic driver.

In today’s value-based healthcare landscape, the demand for real-world evidence and patient-centric insights has never been higher.
Whether your are preparing a Phase IV study, setting up a compliance program, or planning real world data collection initiatives, choosing the right Clinical Research Organization (CRO) is key.

At Novellas Healthcare, we specialize in late-phase research across Belgium and the Netherlands, offering CRO services that combine scientific excellence with local operational know-how.

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Why choose Novellas Healthcare?

What is a Clinical Research Organization (CRO)?

A Clinical Research Organization (CRO) is a partner that supports pharmaceutical, biotech, and medtech companies in designing, running, and analyzing clinical trials. As a contract research organization active in both Belgium and the Netherlands, we help bring structure, speed, and quality to your post-marketing studies.

Unlike traditional CROs focused on early-phase trials, our strength lies in Phase IV and real-world settings—where safety, adherence, and long-term outcomes come into focus.

Local delivery. Global quality.

With deep knowledge of the Belgian and Dutch healthcare systems, we help pharmaceutical, medical devices and biotech companies meet all legal, regulatory and ethical requirements.

We are in regular contacts with authorities such as FAMHP/FAGG and EMA ensuring alignment on:

  • Regulatory strategy and submissions
  • Site and HCP engagement
  • Study monitoring and compliance (Phase IV)
  • GDPR-compliant data management
  • Real world data collection & analysis
  • Patient-reported outcomes and late-phase metrics

Real-world data to take the right decisions

Phase IV studies are not just about extending clinical trials.
They’re about understanding how therapies perform in the real world. We design and execute studies that measure elements such as:

  • Patient retention
  • Patient adherence
  • Health outcomes in chronic diseases & rare conditions
  • Therapy management in day-to-day medical practice
  • Resource utilization and cost-efficiency
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Our CRO services include:

Data management

Our team brings specialized skills in statistical ability, clinical data programming, and advanced statistical analysis, alongside CDISC-related services. This ensures that your clinical trials benefit from accurate, efficient, and fully regulatory-compliant data management.

Biostatistics

Our team brings specialized skills in statistical ability, clinical data programming and advanced statistical analysis, alongside CDISC-related services.

Clinical Operations Support

Our CPMs, CRAs and CTAs provide tailor-made services and functional services according to your needs.

Study Management

A committed clinical trial project director is assigned to your trial, to guarantee you the best operational roll-out.

Regulatory Affairs

Trust a team of experts in regulatory affairs, supporting you in various tasks such as:

  • CTD
  • Integrated summaries for NDAs
  • Briefing documents
  • Clinical expert statements
  • Query management.

Scientific Communication

A dedicated team, available to write, review and create a list of scientific documents adapted to your clinical trial, such as:

  • Protocols
  • Scientific abstracts, posters and slide presentations
  • Patent descriptions
  • Preclinical study reports
  • Scientific literature reviews
  • Website content.

Our Phase 4 trial services also include:

  • Study design & protocol development
  • Regulatory submission & ethics committee handling
  • Site recruitment & HCP coordination
  • Monitoring, reporting & compliance follow-up
  • Data collection platforms and patient communication tools
  • Real world evidence dashboards and insights

Why Novellas Healthcare?

+25 years in Life Sciences

with deep phase IV and post-marketing expertise.

Local CRO

presence in Belgium and the Netherlands.

Flexible, scalable teams

with medical, regulatory, and data expertise.

Proven experience

in compliance phase IV and real world data collection.

Full alignment

with EMA, FAMHP/FAGG and GDPR requirements.

Ready to find the partner for your next Clinical Trial?

Need a partner for your next late-phase trial or real world data project in Belgium or the Netherlands?
Let’s co-create a CRO strategy that supports your brand, your patients — and your success.

Let’s get in touch!

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