What Aixial Group does

Aixial Group is a France-headquartered, full-service Contract Research Organization (CRO) operating as a subsidiary of ALTEN Group. Founded in 1999 and based in Boulogne-Billancourt, the company delivers clinical development services across Phase I-IV, including First-in-Human and Real-World Evidence studies, to pharmaceutical, biotechnology, medical device, cosmetic, agrifood, and veterinary sponsors worldwide. The company reports 1,580+ studies conducted, 610 trial sites, and maximum enrollment of 33,189 patients across its portfolio.

The company offers three engagement models — Full-Service CRO Partnership (end-to-end trial management), Functional Service Provision (FSP, embedded functional teams), and Consulting Services — supported by nine service modules spanning clinical operations, biostatistics, data management, medical writing, pharmacovigilance, regulatory affairs, quality assurance, real-world evidence, and toxicology. Its underlying technology stack includes a proprietary CTMS, E-TMF, e-ISF, Risk Tracking Tool, validated safety databases (Argus, Safety Easy, Veeva Vault), CDISC-compliant biostatistics infrastructure, and the Smart Healthcare Research Program / Aixial R&D Lab, a network of 9 innovation labs across France, the UK, Romania, and Morocco focused on AI, NLP, computer vision, and blockchain applied to clinical research. Therapeutic specialization is concentrated in oncology, rare diseases, CNS, and specialty therapeutics.

Aixial monetizes through professional services contracts priced per engagement via RFP, with no publicly disclosed pricing tiers or revenue figures. The company operates 14 offices across Europe (France, UK, Belgium, Denmark, Spain, Sweden, Switzerland, Romania), North America (USA, Mexico), and Asia (India), and holds ISO 9001:2015, ISO 14001, and ISO 27001 certifications as part of ALTEN Group. Customer acquisition runs primarily through enterprise direct sales supplemented by content marketing, whitepapers, conference presence, and an active RFP submission funnel. As a privately held subsidiary of ALTEN Group, Aixial has no disclosed funding rounds and no equity-level transparency.

Name

Aixial Group

Legal name

AIXIAL

Website

https://aixialgroup.com

Company type

Private

Founded year

1999

Operating status

Operating

Headcount range

1,001–5,000 employees

Short description

Aixial Group is a France-headquartered, full-service Contract Research Organization operating as an ALTEN Group subsidiary, delivering Phase I-IV clinical trials, FSP staffing, and consulting across pharma, biotech, medtech, cosmetic, agrifood, and veterinary verticals in 14 countries.

Ownership category

akta.pro rank

Product category

Clinical Research Organization Services

NAICS

Scientific Research and Development Services (5417), Other Management Consulting Services (541618), Other Scientific and Technical Consulting Services (54169)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Management Consulting Services (8742)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL), Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH), Functional Service Providers (FSP) & Resourcing CROs (HLAGAAAM), Medical Writing & Regulatory Submission Support CROs (HLAGAAAG)

Keywords

• Clinical research organization
• Clinical trial management
• Drug development services
• Pharmacovigilance services
• Regulatory affairs consulting

Headquarters

HQ city

Boulogne-billancourt

HQ country

France

HQ region

Europe

Offices14 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Full-Service CRO Partnership: End-to-end clinical trial management including study design, protocol development, site management, monitoring, data management, and regulatory submission support. Full-service model with experienced people and advanced technology for clinical data management.
2. Functional Service Provision (FSP): Flexible partnership models providing dedicated functional experts deployed across programs and geographies, staff augmentation with seamless integration into client teams, and project outsourcing for focused functional services. Services include biostatistics, clinical data management, medical writing, and pharmacovigilance.
3. Consulting Support: Clinical development capabilities and integrated consulting expertise for protocol review, strategic advisory, and streamlined development support. Committed resources with professionally trained project managers and industry-leading technology for real-time data analytics.

Go-to-market motion3 records

Distribution channels3 records

Marketing channels6 records

Core offering

Aixial Group is a global full-service Contract Research Organization (CRO) that delivers clinical research services to biotech and pharmaceutical sponsors under three flexible engagement models: Full-Service CRO Partnership, Functional Service Provision (FSP), and Consulting. The company manages Phase I-IV trials across therapeutic areas including oncology, rare diseases, CNS, and specialty therapeutics, supported by capabilities in pharmacovigilance, regulatory affairs, biostatistics, data management, and real-world evidence.

Product overview

Aixial Group is a global full-service Contract Research Organization (CRO) offering a platform-plus-partnership model for clinical development. The core portfolio consists of three delivery models: Full-Service CRO Partnership (end-to-end trial management), Functional Service Provision (FSP - dedicated staffing augmentation), and Consulting Services (strategic advisory). These are supported by nine specialized service modules covering Clinical Trial Operations, Medical Writing, Pharmacovigilance & Safety, Quality Assurance, Regulatory Affairs, Statistics & Programming, Data Management, Real-World Evidence, and Toxicology. The company operates across six industry verticals (Pharmaceutical, Biotechnology, Medical Device, Cosmetic, Agrifood, Veterinary) with deep therapeutic expertise in Oncology, Rare Diseases, CNS, and Specialty Therapeutics. An innovation layer called the Aixial R&D Lab (Smart Healthcare Research Program) provides AI-powered capabilities for patient engagement, real-world data analysis, and care coordination. With 30+ years of experience, 1,000+ staff, and operations spanning 13 continents, the company delivers Phase I-IV trials including First-in-Human and Real-World Evidence studies.

Differentiator

Problem solved

Functional benefit

Products and services

• Full-Service CRO Partnership End-to-end clinical trial management covering Phase I-IV including First-in-Human trials and Real-World Evidence studies, for global pharma, biotech, and other life sciences sponsors.
• Functional Service Provision (FSP) Partnership models providing dedicated experts in biometrics, data management, clinical operations, and pharmacovigilance, deployed across programs and geographies with rapid team expansion, staff augmentation, and project outsourcing.
• Consulting Services On-demand high-level strategic, regulatory, and medical writing expertise for sponsors needing advisory support across the clinical development lifecycle, including protocol review and streamlined development support.
• Medical Writing Services Regulatory and scientific documentation services including protocols, clinical study reports, investigator brochures, CTD submissions, and peer-reviewed publication support for life sciences sponsors.
• Pharmacovigilance & Safety Services End-to-end pharmacovigilance services from early-phase through post-marketing, including ICSR processing, signal detection, aggregate reports, risk management plans, and QPPV support using Argus, Safety Easy, and Veeva Vault platforms with MedDRA, WHO Drug, EudraVigilance, Embase, and PubMed databases.
• Quality Assurance Services Transversal quality assurance services including QMS development, SOP creation, training management, audit support, CAPA management, and regulatory inspection readiness for clinical and product lifecycle projects.
• Regulatory Affairs Services Regulatory strategy and submission support across FDA, EMA, and international authorities, covering product lifecycle from early development through approval and marketing for drug products, medical devices, cosmetic products, and food supplements.
• Statistics and Programming Services Statistical analysis, study design input, randomization, SAP development, CDISC-compliant dataset creation (SDTM/ADaM), and regulatory submission programming using SAS and R for clinical development sponsors.
• Data Management Services Database design, eCRF development, data entry, programming, cleaning, validation, and project management compliant with GCP, 21 CFR Part 11, ICH, and CDISC standards for clinical trial sponsors.
• Real-World Evidence Services Observational study design and analysis using secondary data sources (SNDS, EHRs), PASS studies, disease registries, and evidence synthesis for regulatory and HTA submissions in clinical development.
• Toxicology Services Non-clinical safety assessment including impurity qualification, extractables/leachables evaluation, aggregate exposure assessment, and regulatory toxicology strategy aligned with ICH, EMA, and FDA guidelines for drug development sponsors.
• Oncology Clinical Research Services Specialized oncology trial delivery with expertise in complex designs (dose escalation, adaptive, basket, umbrella studies), biomarker-driven approaches, and radiopharmaceutical trials across 37+ tumor types including rare and orphan indications.
• Rare Disease Clinical Research Services Rare disease program support including orphan drug designation strategy, adaptive trial designs, natural history studies, and regulatory pathway navigation across 100+ indications, with trial sizes up to 5,000 patients and 216 sites.
• CNS Clinical Research Services Neurological and neurodegenerative disease trial expertise including Alzheimer's, Parkinson's, MS, ALS, and epilepsy with cognitive and functional endpoint assessment capabilities across 36 indications.
• Medical Device Clinical Services MDR/IVDR compliance support, clinical evaluation reports (CER), PMCF studies, usability trials, materiovigilance, and SaMD validation for medical devices across all risk classifications for medtech manufacturers.
• Cosmetic Clinical Services Pharmaceutical-grade clinical and regulatory services for cosmetic brands including efficacy validation, cosmetovigilance, safety monitoring, and MoCRA/EU regulatory compliance.
• Agrifood Clinical Services Clinical research and regulatory support for functional foods, nutraceuticals, dietary supplements, and novel food ingredients with EFSA health claim validation and nutrivigilance services.
• Veterinary Clinical Services Veterinary clinical trial and regulatory services for pharmaceuticals, vaccines, biologics, feed additives, and diagnostics supporting EMA/FDA approvals for animal health companies.
• Clinical Trial Operations Services Operational management including global study management, clinical research associate monitoring, trial assistant support, and supply chain management with proprietary CTMS, E-TMF, and Risk Tracking tools for clinical trial sponsors.

Quantifiable outcome

• 1,580+ studies conducted across Phase I-IV
• +3 more outcomes

Named customers3 records

Segments6 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration11 records

AI capability8 records

Feature7 records

Partnerships

Five partnerships are on record, tiered core, strategic and minor.

• Crism Therapeutics CorpcoreStrategic or Co-development Partner · 25 June 2026Crism Therapeutics Corporation is working with Aixial Group as its contract research organization to finalize site activation steps for Phase 2 clinical trial of irinotecan-ChemoSeed in treating glioblastoma. Patient dosing guidance extended to H1 2026.
• ALTEN GroupcoreOthers · 1 April 2025ALTEN Group is the parent company of Aixial Group. All ALTEN Group systems are ISO 14001, 27001, and 9001 certified. ALTEN and Aixial joined forces with Efrei for explainable AI in healthcare.
• EFREI Research LabstrategicTechnology or IntegrationAixial R&D Lab partnership with EFREI Research Lab for integrating AI into clinical research. This alliance aims to revolutionize patient and healthcare provider experiences, marking a pivotal step in healthcare innovation.
• Lincoln LabstrategicTechnology or IntegrationAixial R&D Lab partnership with Lincoln Lab for integrating AI into clinical research. Part of the 9-innovation-lab network driving innovation in AI, explainable AI, NLP, computer vision, blockchain, and robotics.
• Petit Coeur de BeurreminorStrategic or Co-development PartnerPartnership using data analysis to improve the lives of individuals with congenital heart disease. Managing Director Gaëlle Marguin of Petit Coeur de Beurre collaborating with Stéphane Thérèse, Managing Director of Aixial.

Scale indicators26 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• IQVIA: The world's largest CRO with full-service clinical, FSP, and consulting offerings across all therapeutic areas and geographies. Directly competes with Aixial on large full-service RFPs while also representing the scale benchmark Aixial is measured against.
• ICON plc: Global full-service CRO formed via the PRA Health Sciences merger, offering clinical, FSP, and consulting services across pharma and biotech. Competes with Aixial in oncology, rare disease, and CNS, particularly for European-headquartered sponsor work.
• Labcorp Drug Development (Covance): Full-service CRO spun from Labcorp with deep central laboratory, clinical, and bioanalytical capabilities. Competes with Aixial on integrated lab-plus-clinical offerings and large global sponsor programs.
• Syneos Health: Full-service CRO with clinical and commercial services across all therapeutic areas. Directly competes with Aixial on biotech and pharma full-service engagements, particularly in oncology and CNS.
• Parexel: Global full-service CRO with strong oncology, rare disease, and regulatory consulting capabilities. Competes with Aixial on complex specialty therapeutic area engagements and global Phase II-IV programs.
• Charles River Laboratories: Diversified CRO offering discovery, safety assessment, and clinical services with particular strength in early-phase and toxicology. Overlaps with Aixial's toxicology and early-phase clinical offerings.

Direct peers

• Medpace: Mid-to-large full-service CRO specializing in complex therapeutic areas including oncology, CNS, and rare diseases. Closely comparable to Aixial in scale, specialty therapeutic focus, and biotech sponsor orientation.
• Worldwide Clinical Trials: Mid-size global CRO focused on complex clinical trials in CNS, oncology, rare diseases, and cardiometabolic indications. Closely comparable to Aixial in therapeutic-area focus, scale, and biotech sponsor mix.
• Premier Research: Specialty CRO focused on biotech and rare disease with deep expertise in pediatric and CNS trials. Highly comparable to Aixial in therapeutic-area specialization, mid-size scale, and biotech-oriented customer base.

Emerging players

• Celerion: Early-phase clinical and bioanalytical CRO with strong pharmacokinetic, pharmacodynamic, and first-in-human capabilities. Overlaps with Aixial on Phase I trials and specialized bioanalytical services.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/aixialgroup

Compliance8 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 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 Aixial Group