What AXONAL-BIOSTATEM does

AXONAL-BIOSTATEM is a France-based, full-service independent Contract Research Organization (CRO) founded in 1993 and headquartered in Nanterre, with a secondary office in Vendargues. The firm provides end-to-end clinical research services — project management, monitoring, data management, biostatistics, medical writing, technical assistance, vigilance management, and on-site staffing — to pharmaceutical, medical device, biotechnology, and academic sponsors across Phase I/II through IV, early/compassionate access (ATU/RTU), non-interventional, and PASS/SCAC post-marketing studies. It also operates ACUITUDE, a holding-entity platform for healthcare professional fees management by the pharmaceutical industry.

The company's technology platform centers on the Ennov Clinical EDC system (15+ years of in-house expertise), supporting eCRF, ePRO, IWRS randomization, CTMS, and mobile applications, with compliance to 21 CFR Part 11, GAMP 5, GDPR, and CDISC (SDTM, SAS, XML). Core differentiating capabilities are French regulatory specialization in ANSM/HAS early-access and SNDS-linked real-world evidence studies, plus therapeutic-area expertise across oncology, rare diseases, dermatology, ophthalmology, neurology, psychiatry, cardiology, diabetology, pneumology, and infectious diseases. The firm has held Top 3 independent French CRO status for more than 10 years, is ISO 9001 certified (25+ years) and ISO 26000-aligned, and operates internationally across Europe, Maghreb, Africa, Brazil, Argentina, and Mexico.

The business model is B2B professional services revenue generated through custom-quoted, project-based engagements with enterprise pharma, medical device, and biotech clients, supplemented by technical solutions (eCRF/ePRO/IWRS), training and consulting (including EPITEM workshops), and the ACUITUDE managed-services fees platform. In December 2023, AXONAL-BIOSTATEM was acquired by Docaposte, a subsidiary of La Poste Groupe, and rebranded in 2024 as Heva, repositioning the firm as a sovereign, ethical health data processing platform for research under the La Poste Santé & Autonomie umbrella.

Name

AXONAL-BIOSTATEM

Legal name

AXONAL-BIOSTATEM

Website

https://axonalbiostatem.com

Company type

Private

Founded year

1993

Operating status

Operating

Headcount range

51–100 employees

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) Services

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (54171)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Real-World Evidence (RWE), HEOR & Epidemiology CROs (HLAGAAAK), Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH), Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL)

Keywords

• Clinical research services
• Contract research organization
• Pharmaceutical clinical trials
• Medical device studies
• Biostatistics and data management

Headquarters

HQ city

Paris

HQ country

France

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Clinical Research Services: Full-service CRO providing comprehensive clinical research management including project management, monitoring, data management, statistics, medical writing, technical assistance, vigilance management, and on-site services. Revenue generated through project-based engagements with pharmaceutical, biotech, medical device companies and academic sponsors.
2. Technical Solutions: Provision of technical solutions including eCRF, ePRO, IWRS randomization, apps on smartphones and tablets, and development of specific applications. Can be offered as standalone services or integrated with broader project engagements.
3. Training and Consulting: Training services covering technical aspects of study design and implementation, regulatory framework for clinical evaluation, and methodological subjects in statistics. Includes webinars, intra-company training, and seminars such as EPITEM workshops.
4. Fees Management Platform: ACUITUDE holding provides consulting, training and assistance services in health field along with fees management platform facilitating management of healthcare professional remuneration by pharmaceutical industry.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

AXONAL-BIOSTATEM is a full-service Contract Research Organization (CRO) that designs, conducts, and analyzes clinical and epidemiological studies for pharmaceutical, biotechnology, and medical device manufacturers, as well as academic sponsors. Its offerings span the full study lifecycle, including project management, monitoring, data management (via the Ennov Clinical® EDC platform), biostatistics, medical writing, vigilance/pharmacovigilance management, on-site clinical staffing, technical assistance, and customized e-clinical tools (eCRF, ePRO, IWRS, CTMS). The firm covers Phase I/II–IV trials, early access and compassionate access programs (ATU/RTU), non-interventional studies, real-world evidence, SNDS-linked studies, and medical device CE marking / post-marketing studies.

Product overview

AXONAL-BIOSTATEM is a full-service Contract Research Organization (CRO) offering comprehensive clinical research services. The company operates as a platform of integrated services including Project Management, Monitoring, Data Management (powered by Ennov Clinical EDC), Statistics/Biometrics, Medical Writing, Technical Assistance, Specific Tools (eCRF, ePRO, IWRS, CTMS), Vigilance Management, and On-Site Services. ACUITUDE provides fees management for healthcare professional remuneration. The company rebranded to Heva in 2024 following acquisition by Docaposte (La Poste Groupe). Services span phases I-IV clinical trials, non-interventional studies, early access programs, and medical device studies.

Differentiator

Problem solved

Functional benefit

Products and services

• Clinical Project Management Services Project Managers, Clinical Trial Assistants, and Clinical Research Associates managing the full lifecycle of clinical study projects with autonomy supported by a Senior Director. Sold to pharmaceutical, biotech, medical device, and academic sponsors.
• Clinical Monitoring Services Feasibility and center selection, initiation visits (on-site or telephone), remote monitoring with EDCs and RBM indicators, on-site monitoring, and site closure. Sold to clinical trial sponsors.
• Clinical Data Management Services Standardized, validated, and documented data management processes executed on the Ennov Clinical EDC system with 21 CFR Part 11, GAMP 5, and GDPR compliance. Sold to clinical study sponsors requiring electronic data capture and validated data flows.
• Biostatistics and Biometrics Services Senior biostatisticians and methodologists deliver protocol design, statistical analysis plans, and reports aligned with FDA, EMA, ICH-E9, ENCEPP, ADELF, and HAS guidelines, with programming in SAS including ADaM format. Sold to clinical trial sponsors.
• Medical Writing Services Production of protocols, clinical study reports, articles, and communications by in-house writers and a network of independent medical writers with therapeutic area expertise. Sold to pharmaceutical, biotech, medical device, and academic sponsors.
• Technical Assistance and Clinical Staffing Provision of qualified consultants serving as project managers, data managers, Clinical Research Associates (CRAs), statisticians, and other clinical research roles. Sold to clients needing flexible resourcing for clinical research functions.
• e-Clinical Specific Tools (eCRF, ePRO, IWRS, CTMS) Custom digital solutions including electronic Case Report Forms (eCRF), electronic Patient Reported Outcomes (ePRO) apps, specific scoring tools, educational tools, mobile device applications, IWRS randomization, and Clinical Trial Management Systems (CTMS). Sold to sponsors on a standalone basis or integrated with broader engagements.
• Vigilance and Pharmacovigilance Management Services Adverse event detection and notification, Safety Management Plan drafting, reconciliation management, additional information request follow-up, and adjudication committee organization. Sold to clinical trial sponsors needing safety reporting.
• On-Site Clinical Services Provision of Clinical Study Technicians (TEC) and Clinical Research Nurses (IRC) to support investigative sites. Sold to sponsors conducting clinical studies that require dedicated on-site clinical research personnel.
• ACUITUDE Healthcare Professional Fees Management Platform Platform for managing healthcare professional remuneration by pharmaceutical industry sponsors, delivered via the ACUITUDE holding entity. Sold to pharmaceutical companies needing compliant fees management.
• Training and Consulting on Clinical Research Training programs on study design and implementation, regulatory framework for clinical evaluation (including ANSM/HAS), and statistical methodology, available as webinars, intra-company sessions, and EPITEM seminars. Sold to pharmaceutical, biotech, medical device companies and academic teams.

Quantifiable outcome

• More than 1,000 studies completed with 130+ scientific publications
• +3 more outcomes

Named customers1 record

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Four partnerships are on record, tiered core and major.

• IPSEAcoreStrategic or Co-development PartnerAXONAL-BIOSTATEM has signed a partnership with IPSEA (Association de recherche pour le développement de la recherche qualitative en santé) to conduct qualitative studies. IPSEA specializes in qualitative health research and together they offer comprehensive research capabilities including patient experience evaluation.
• stève consultantsmajorStrategic or Co-development PartnerStrategic partnership for conducting webinars and training on Early Access programs, Compassionate Access, and SNDS chained studies methodology. stève consultants provides health economics and market access expertise while AXONAL-BIOSTATEM contributes clinical research capabilities.
• AFCROscoreOthersActive membership in AFCROs (Association Française des Sociétés de Recherche Clinique par Contractat) for more than 20 years. French professional association of CROs providing industry representation, networking, and participation in policy discussions with health authorities.
• EUCROFcoreOthersActive membership in EUCROF (European CRO Federation) for more than 20 years. European professional association providing industry representation, best practice sharing, and regulatory advocacy at European level.

Scale indicators6 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Biotrial: Independent French CRO based in Rennes providing full-service early-stage clinical research, including Phase I units and bioanalysis, with strong oncology and CNS expertise. Directly comparable to Axonal-Biostatem as a French-headquartered CRO serving pharma/biotech sponsors with a comprehensive clinical service offering.
• Excelya: European CRO with significant French presence offering biostatistics, data management, clinical operations, and pharmacovigilance services. Comparable as a mid-sized European CRO with overlapping service breadth and customer segments (pharma, biotech, medical devices).
• Keyrus Life Sciences: France-headquartered clinical research and life sciences consulting firm providing biometrics, real-world evidence, and clinical operations services. Closely comparable to Axonal-Biostatem on its French-rooted biometrics and RWE positioning for pharma/biotech sponsors.
• Clinact: French CRO providing clinical operations, biometrics, project management, and real-world evidence services to pharma and medical device clients. Direct French competitor with comparable mid-sized, full-service clinical research model targeting similar sponsors and study types.

Broad incumbents

• IQVIA: World's largest CRO with full-service clinical operations, real-world evidence, and data/technology services for pharma and medical device sponsors. Comparable as a global full-service CRO competitor whose biostatistics, RWE, and Phase I–IV capabilities compete for the same enterprise sponsors Axonal-Biostatem serves.
• Parexel International: Global CRO providing clinical operations, real-world evidence, biostatistics, and regulatory services across therapeutic areas. Comparable as a Tier-1 full-service CRO whose clinical and biometrics capabilities overlap with Axonal-Biostatem's service mix for European pharma/biotech sponsors.
• Worldwide Clinical Trials: Mid-to-large global CRO focused on complex therapeutic areas (oncology, CNS, rare disease) with full-service clinical, biometrics, and medical device capabilities. Comparable incumbent competing for the same specialty clinical and medical device study types Axonal-Biostatem/Heva supports.
• ICON plc: Global full-service CRO offering clinical operations, labs, biometrics, and commercial services to pharma and medical device sponsors. Comparable large incumbent competing in the same clinical research services categories, particularly for European mid-sized and large pharma engagements.
• Eurofins CRO Services: Broad life-sciences testing and CRO services arm of Eurofins Group, covering clinical, bioanalytical, and central lab services globally. Comparable incumbent that overlaps with Axonal-Biostatem's data management, biostatistics, and central lab-adjacent services but as part of a much larger diversified testing platform.

Emerging players

• RTI Health Solutions: Specialized real-world evidence and health economics CRO serving pharma, with deep expertise in observational studies, registries, and HEOR. Comparable to Axonal-Biostatem's RWE and pharmacoepidemiology practice, including SNDS-style observational research, on a more focused niche footprint.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/axonal
• Xx.com/AxonalBiostatem

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Subsidiaries1 record

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 AXONAL-BIOSTATEM