What Axelys Santé does

Axelys Santé is a privately held French Contract Research Organization (CRO) founded in 2013 and headquartered in Malakoff, near Paris, with a regional office in Hydra, Algiers, to cover the MENA market. The firm delivers outsourced clinical research and adjacent pharmaceutical services to pharmaceutical, biotechnology, medtech, in-vitro diagnostic, cosmetics, and food supplement manufacturers, as well as public research institutions, across six therapeutic areas: oncology, infectious diseases, hematology, rare diseases, inflammation and immunology, and cardiovascular/metabolic disease.

Its service offering is organized around five integrated pillars — clinical studies, medical affairs and scientific communication, pharmaceutical and regulatory affairs, and a 24/7 medical information service — plus a market access pillar and à la carte modules for biometrics, monitoring and data management, and quality management systems. Clinical delivery uses biostatistics in SAS and R, electronic Case Report Forms (eCRF), database management, and regulatory submissions to ANSM, CPP, CNIL, and EU CE-marking pathways, with compliance coverage of GDPR, the AI Act, MDR, EHDS, and the French Anti-gift Law and Sunshine Act. The firm is ISO 9001:2015 certified by Bureau Veritas as of 2025 and reports 120+ scientific publications and 70+ partner relationships.

Axelys Santé operates a B2B professional services model with project-based pricing, no public pricing tiers, and direct enterprise engagement. It cites relationships with large sponsors including Pfizer, Gilead Sciences, Galderma, Galapagos, Tillotts Pharma, Santhera, Kyowa Kirin, Unilever, LUPIN, and the French National Institute of Health and Medical Research (Inserm). Memberships in AFCROs, EUCROF, France Biotech, France Innovation, and Mab Design anchor its positioning within the European clinical research and biotech ecosystem. Revenue is not publicly disclosed and no funding rounds or institutional investors are recorded.

Name

Axelys Santé

Legal name

Axelys Santé

Website

https://axelys-sante.com

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

1–10 employees

Short description

Axelys Santé is a France-headquartered Contract Research Organization founded in 2013 that delivers outsourced clinical research, regulatory affairs, medical affairs, market access, and 24/7 medical information services to pharmaceutical, biotech, medtech, cosmetics, food supplement, and public research clients across six therapeutic areas and the EU and MENA regions.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) Services

NAICS

Scientific Research and Development Services (5417), Management, Scientific, and Technical Consulting Services (5416), Research and Development in the Physical, Engineering, and Life Sciences (54171)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Engineering, Accounting, Research, Management (8700)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH), Medical Writing & Regulatory Submission Support CROs (HLAGAAAG), Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL)

Keywords

• Clinical research services
• Contract research organization
• Regulatory affairs consulting
• Medical affairs services
• Market access consulting

Headquarters

HQ city

Malakoff

HQ country

France

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. CRO Services - Clinical Studies: Full-service Contract Research Organization providing end-to-end clinical trial management from study design through reporting. Revenue generated through project-based professional services contracts.
2. Regulatory & Pharmaceutical Affairs: Regulatory submissions, pharmaceutical assistance, compliance services, and quality management system support for operating laboratories.
3. Medical Affairs & Market Access: Medical writing, scientific communication, KOL management, expert meetings, and market access strategy services including pricing and reimbursement negotiations.
4. Medical Information Services: 24/7 medical information hotline, pharmacovigilance case notification, quality complaints management, and crisis management services.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

Axelys Santé is a Contract Research Organization (CRO) providing outsourced clinical research and related services to pharmaceutical, biotech, medtech, cosmetics, and food supplement manufacturers. Core offerings span Clinical Studies (full-service trial management from feasibility to reporting), Pharmaceutical & Regulatory Affairs, Medical Affairs & Scientific Communication, Medical Information (24/7), Market Access, and à la carte modules covering Biometrics, Monitoring & Data Management, and Quality Management System.

Product overview

Axelys Santé is a Contract Research Organization (CRO) offering a comprehensive suite of clinical research services. The company provides six integrated service pillars: Clinical Studies (full-service trial management from feasibility through reporting), Medical Affairs & Scientific Communication, Pharmaceutical & Regulatory Affairs, Medical Information (24/7 support), and Market Access. Customizable 'à la carte' modules include Biometrics (statistical analysis using SAS/R), Monitoring & Data Management, and Quality Management System. The company covers medications, medical devices, in-vitro diagnostic devices, cosmetics, and food supplements across oncology, infectious diseases, hematology, rare diseases, inflammation & immunology, and other therapeutic areas.

Differentiator

Problem solved

Functional benefit

Products and services

• Clinical Studies (Études cliniques) Full-service clinical trial management covering feasibility assessment, study design, regulatory submissions to ANSM, CPP and CNIL, site selection, on-site and remote monitoring, data management, statistical analysis using SAS/R, and final reporting with scientific publication support. Designed for pharmaceutical, biotech, medtech and cosmetics manufacturers needing outsourced clinical trial execution.
• Medical Affairs & Scientific Communication (Affaires Médicales & Communication Scientifique) Medical writing services for abstracts, scientific articles, posters and newsletters; sales team training and medical marketing support; Key Opinion Leader (KOL) relationship management; expert meeting organization and moderation; and regulatory and promotional compliance support. Designed for healthcare companies needing to communicate scientific evidence and engage with medical stakeholders.
• Pharmaceutical & Regulatory Affairs (Affaires Pharmaceutiques & Règlementaires) Regulatory submissions for clinical research and Marketing Authorization (AMM) and CE marking; pharmaceutical assistance including interim responsible pharmacists (PRI), batch tracking, and recall management; advertising compliance and visa management; Anti-gift Law and Sunshine Act compliance; GDPR compliance; and Quality Management System support. Designed for pharmaceutical, medtech, cosmetics and food supplement companies needing regulatory and compliance services.
• Medical Information (Information Médicale) 24/7 medical information service handling incoming calls and written requests at levels 1 and 2; pharmacovigilance case identification and notification; quality complaint management; crisis management for batch recalls and stock shortages; and medical-scientific monitoring and bibliographic research. Designed for pharmaceutical and medtech companies needing round-the-clock medical information support.
• Market Access Market access strategy development, pricing and reimbursement optimization, transparency and price file preparation and submission, Early Access Authorization (AAP) and Compassionate Access Authorization (AAC) dossier management, economic and clinical impact assessments, and competitive analysis. Designed for pharmaceutical companies preparing products for launch and reimbursement in France and Europe.
• Biometrics (Biométrie) Statistical analysis services including methodological recommendations, sample size calculation, statistical analysis plan development; document and questionnaire drafting; data collection and management (CRF/eCRF design); data validation (DVP/DMP); statistical analyses using SAS and R; and results presentation and scientific valorization. Designed for clinical trial sponsors needing biostatistics and data analysis support.
• Monitoring & Data Management Clinical trial monitoring services including on-site and remote visit management, investigator site support and training, continuous reporting, database management, audit services, and performance optimization solutions for recruitment, compliance, and query resolution. Designed for clinical trial sponsors needing outsourced monitoring and data management.
• Quality Management System (Système de Management de la Qualité)

Quantifiable outcome

• 120+ scientific publications produced
• +2 more outcomes

Named customers16 records

Segments6 records

Ideal customer profiles5 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

13 partnerships are on record, tiered core, moderate and major.

• AFCROscoreStrategic or Co-development PartnerAssociation Française des Contract Research Organizations. Axelys Santé is an active member participating in industry events, the FIRC Forum d'Innovation en Recherche Clinique, and adhering to AFCROs standards for CRO operations.
• EUCROFcoreStrategic or Co-development PartnerEuropean CRO Federation representing excellence and commitment in clinical research. Membership provides European industry representation and networking.
• France BiotechmoderateStrategic or Co-development PartnerAssociation representing innovation and biotechnology in France. Partnership supports connection with biotech companies requiring clinical research services.
• France InnovationmoderateStrategic or Co-development PartnerAssociation symbolizing commitment to technological innovation in France. Partnership supports innovation ecosystem connections.
• Mab DesignmoderateStrategic or Co-development PartnerReference organization in biomedicines and biotechnological innovation. Partnership supports connections in biologics and advanced therapy development.
• GalapagosmoderateGTM or Marketing PartnerBiotechnology company specializing in innovative medicines. Listed as a customer partner on Axelys Santé website.
• Tillotts PharmamoderateGTM or Marketing PartnerExpert in gastroenterology treatments. Listed as a customer partner.
• GaldermamoderateGTM or Marketing PartnerExpert in dermatological solutions. Listed as a customer partner.
• PfizermajorGTM or Marketing PartnerGlobal biopharmaceutical company. Listed as a customer partner.
• Gilead SciencesmajorGTM or Marketing PartnerLeader in innovative healthcare and medicines. Listed as a customer partner.
• InsermmajorStrategic or Co-development PartnerFrench National Institute of Health and Medical Research. Listed as a partner representing connection with public research.
• SantheramoderateGTM or Marketing PartnerBiopharmaceutical company developing treatments for rare diseases and neuromuscular conditions. Listed as a customer partner.
• Kyowa KirinmoderateGTM or Marketing PartnerInternational company dedicated to pharmaceutical research and medical innovation. Listed as a customer partner.

Scale indicators5 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Clinipace Worldwide: Mid-size global CRO providing clinical operations, biostatistics, and regulatory services to emerging biopharma. Comparable on full-service coverage and mid-tier sponsor focus.
• Veristat: US-based specialist CRO focused on biostatistics, regulatory, and clinical services for small and mid-size biopharma. Comparable on data-management/biometrics-led positioning and sponsor profile of emerging pharma.
• Excelya: French-headquartered European CRO of broadly comparable size and service breadth, covering clinical operations, biostatistics, regulatory, and pharmacovigilance for pharma, biotech, and medtech sponsors. Most direct CRO-peer competitor to Axelys Santé in the French small-CRO segment.
• Biotrial: European clinical research organization headquartered in France with deep therapeutic expertise across neurology, oncology, and rare diseases. Comparable as another France-rooted mid-sized full-service CRO competing for similar sponsor clients.
• Atlantic Research Group: US-based specialty CRO providing full-service clinical trial management and biometrics to biotechs. Comparable on biometrics + monitoring bundles and small-to-mid sponsor focus.
• Premier Research: Specialty CRO with specific depth in rare diseases, oncology, and pediatric populations. Comparable therapeutic specialization and mid-size CRO position to Axelys Santé.
• Rho (now part of Resolian): Specialty mid-size CRO with particular depth in biostatistics, statistical programming, and clinical data management across multiple TAs. Comparable on biometrics emphasis and small-to-mid CRO position similar to Axelys.

Broad incumbents

• Worldwide Clinical Trials: Mid-size global CRO providing full-service Phase I–IV clinical development, real-world evidence, and post-approval services. Comparable service scope with deeper operational scale across geographies.
• Medpace: Larger US-headquartered mid-tier CRO offering full-service clinical development with particular depth in small and mid-sized biopharma. Comparable service breadth but at materially greater scale than Axelys.
• Eurofins Clinical Research Services: European-headquartered CRO and bioanalytical laboratory network offering clinical operations and bioanalytical/CDMO-adjacent services. Comparable European footprint and full-service positioning but at much broader scale.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/axelys-sante
• Xx.com/axelys_sante
• Facebookfacebook.com/axelyssante

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 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 Axelys Santé