What Harmony Clinical Research does

Harmony Clinical Research BV (HarmonyCR) is a privately held Belgian Contract Research Organization founded in January 2012 by Jacqueline Hertoghs and Tom Van Paepegem and headquartered in Merelbeke-Melle, Belgium. The firm delivers both full-service and modular clinical research services for Phase I-IV trials, with a stated primary focus on early-phase (I/II) and vaccine studies. Service modules cover the full clinical trial lifecycle — medical writing, regulatory affairs, project management, site management, data management, statistics, pharmacovigilance, and medical monitoring — and can be procured as a complete package or as stand-alone offerings. A second line of business supplies flexible staffing of Project Managers, Clinical Research Associates, Clinical Trial Associates, and Study Coordinators, deployed under the client's Quality Management System on a project, temporary, part-time, or full-time basis at the client site, home-based, or hybrid.

The technology stack is built on best-of-breed third-party clinical research platforms rather than proprietary systems: Viedoc is used for electronic data capture (eCRF) including eDiary and ePRO modules, BSI's eTMF solution was selected in 2024 with go-live planned for spring 2024 to support European and overseas expansion, Eudravigilance CTM underpins pharmacovigilance reporting, and historical job requirements reference Veeva Vault eTMF experience. There is no documented proprietary platform, AI/ML capability, or data flywheel in the input material.

Commercially, HarmonyCR sells through dedicated enterprise field sales led by Business Development Manager Jelle De Keukeleire and channel partnerships with carefully selected local CROs for geographies outside Belgium, the Netherlands, and Luxembourg, enabling coverage across most of Europe plus the USA and Canada. Pricing is quote-based and not publicly disclosed; contract terms vary from multi-year engagements to project-based and staffing arrangements. Customers span pharmaceutical, biotechnology, nutritional, medical device companies, other CROs, academic organizations, and governmental institutions. The firm holds Belgian Crédit d'impôt recherche (CIR) research tax credit accreditation and is GDPR-compliant, and is a member of BIO Vlaanderen (Biovia), Becro, Biowin, and Immunity for Health (I4H). Founder Tom Van Paepegem became CEO in 2022 following Jacqueline Hertoghs' retirement, and the company hired its first Netherlands-based employee in 2023.

Name

Harmony Clinical Research

Legal name

Harmony Clinical Research BV

Website

https://harmony-cr.com

Company type

Private

Founded year

2012

Operating status

Operating

Headcount range

11–50 employees

Short description

Harmony Clinical Research is a Belgian Contract Research Organization providing full-service and modular clinical trial support plus flexible staffing of clinical professionals to pharmaceutical, biotech, medical device, nutrition, and CRO clients across Benelux and broader Europe.

Ownership category

akta.pro rank

Product category

Clinical Research Services (Contract Research Organization)

NAICS

Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Clinical Operations & Monitoring FSP (CRA/CTM/Start-up) (HLAGAOAA), Clinical Trial Monitoring Support (On-site/Remote) (HLAGACAG), Medical Writing & Regulatory Submission Support CROs (HLAGAAAG)

Keywords

• Clinical research services
• Contract research organization
• Clinical trial management
• Clinical staffing solutions
• Regulatory affairs services

Headquarters

HQ city

Melle

HQ country

Belgium

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure

Revenue model

1. Clinical Services: Full-service and modular clinical research services including medical writing, regulatory affairs, project management, site management, data management, statistics, pharmacovigilance, and medical monitoring. Services can be provided as complete package or individual stand-alone services.
2. Staffing Services: Flexible staffing solutions offering Project Managers, Clinical Research Associates, Clinical Trial Associates, and Study Coordinators on project basis, temporary, part-time, or full-time basis. Outsourced staff work under client's Quality Management System.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels3 records

Core offering

Harmony Clinical Research (HarmonyCR) is a Belgium-based Contract Research Organization (CRO) providing clinical trial services and flexible staffing across the full clinical trial lifecycle. Its Clinical Services line covers medical writing, regulatory affairs, project management, site management, data management, statistics, pharmacovigilance, and medical monitoring, delivered as a full-service package or modular stand-alone services. Its Staffing Services line supplies experienced Project Managers, Clinical Research Associates, Clinical Trial Associates, and Study Coordinators on project, temporary, part-time, or full-time basis under the client's Quality Management System.

Product overview

Harmony Clinical Research operates as a Contract Research Organization (CRO) offering two primary service lines: Clinical Services and Staffing Services. Clinical Services is a comprehensive, modular platform providing end-to-end clinical trial support including medical writing, regulatory affairs, project management, site management, data management (using Viedoc eCRF), statistics, pharmacovigilance, and medical monitoring. These services can be delivered as a full-service package or as stand-alone modular services depending on client needs. Staffing Services provides flexible outsourcing of clinical research professionals. The company primarily focuses on early phase clinical trials (Phase I/II) and vaccine trials across Belgium, The Netherlands, Luxembourg, other European countries, USA, and Canada.

Differentiator

Problem solved

Functional benefit

Products and services

• Clinical Services Comprehensive clinical research services covering the full clinical trial lifecycle. Services include medical writing, regulatory affairs, project management, site management, data management, statistics, pharmacovigilance, and medical monitoring. Delivered as a full-service package or as modular/stand-alone services for pharmaceutical, biotech, nutritional, medical device companies, CROs, academic organizations, and governmental institutions.
• Staffing Services Flexible staffing services providing experienced Project Managers, Clinical Research Associates, Clinical Trial Associates, and Study Coordinators on a project, temporary, part-time, or full-time basis. Outsourced staff can work at the client's office, home-based, or in a hybrid model under the client's Quality Management System.

Quantifiable outcome

• 45 days for CTR approval via new Clinical Trial Regulation
• +1 more outcomes

Named customers10 records

Segments7 records

Ideal customer profiles5 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration3 records

Feature3 records

Partnerships

Seven partnerships are on record, tiered core and minor.

• Local CRO PartnerscoreChannel Partner/ Reseller/ DistributorCarefully selected local CRO partners for regulatory and monitoring services outside core countries (Belgium, Netherlands, Luxembourg). These partnerships ensure broad geographical coverage and service solutions for clients requiring support in additional countries.
• BIO Vlaanderen (Biovia)minorOthersMembership in Belgian biotech and life sciences industry association for networking and industry representation.
• Immunity for Health (I4H)minorOthersMembership in health-related organization focused on immunity research and development.
• BecrominorOthersBelgian contract research organization network membership providing industry connections and collaboration opportunities.
• BiowinminorOthersMembership in Walloon health cluster organization supporting biotech and health innovation ecosystem.
• BSI (eTMF Solution)coreTechnology or IntegrationBSI eTMF (Trial Master File) solution selected to support expanding operations. Software is highly scalable and tailored to support growing customer base in Europe and overseas. Implementation planned for spring 2024.
• Viedoc (eCRF System)coreTechnology or IntegrationViedoc eCRF system used for electronic case report forms, including modules for eDiary and ePRO, with video call capability for remote visits. All modules compliant with smartphone, tablet, and computer.

Scale indicators6 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• ICON plc: Global top-5 full-service CRO serving large pharma and biotech across all phases, geographies, and therapeutic areas. Provides the broader competitive backdrop against which Harmony competes for biotech mandates; significant overlap in clinical monitoring and staffing services.
• Charles River Laboratories: Global CRO with particular strength in early-phase clinical research and vaccine/biologics development — directly adjacent to Harmony's stated Phase I/II and vaccine focus. Provides a market-leading incumbent benchmark for early-phase CRO services.
• Eurofins Scientific: Global testing and contract research services group headquartered in Luxembourg with significant operations across Benelux. Adjacent overlap in clinical trial laboratory testing and central lab services supporting clinical trials.
• SGS Health Sciences: Global testing, inspection and certification group with a substantial clinical research business including Phase I–IV clinical operations and bioanalytical/central lab services. Operates as a broad incumbent in the same CRO market category from Belgium.

Direct peers

• IDDI: Belgium-based clinical research services provider specializing in biostatistics, data management, and clinical operations for biotech and pharma sponsors. Same Benelux base, similar boutique CRO positioning, and overlapping customer segments (early-phase oncology, rare disease biotech).
• Cromsource: Italy-headquartered European mid-sized CRO with similar full-service and FSP staffing offerings across pharma, biotech, and medical device sponsors. Comparable mid-tier scale and European geographic reach.
• TFS International (now TFS HealthScience): Sweden-headquartered mid-sized CRO providing clinical operations, biometrics, and FSP services. Similar full-service + modular offering and target customer base of biotech and specialty pharma.
• Venn Life Sciences: European-focused clinical CRO offering full-service and resourcing solutions to small and mid-sized pharma/biotech. Highly comparable in size, service mix, and customer profile (early-stage biotech).
• ARCHEMED Medical Services: German specialty CRO offering clinical operations, biometrics, and regulatory services across Europe. Comparable boutique scale and full-service/modular delivery model with strong reputation in early-phase and niche-therapeutic trials.
• PSI CRO: Switzerland-based privately held mid-sized global CRO providing clinical operations and staffing across all phases for biotech and pharma. Comparable boutique scale, private ownership, and emphasis on agile, sponsor-centric delivery.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/harmony-clinical-research-bvba

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Harmony Clinical Research