What ALSINOVA does

Alsinova is a France-headquartered Contract Research Organization (CRO) operating as a wholly-owned subsidiary of the Astek Group. The company delivers end-to-end clinical research services spanning non-clinical and pre-clinical phases through clinical trials, Early Access Programs, and Real-World Evidence studies. Its primary customers are large pharmaceutical companies, biotechnology firms, medical device manufacturers, and healthcare institutions, with secondary coverage in cosmetics, agri-food, and veterinary verticals. Operations span 26 countries across Europe, Asia, America, and Africa, leveraging Astek Group's global network for localized delivery of multinational studies.

Alsinova operates through three delivery models: Consulting (expert resource placement), Functional Service Provider (FSP) with dedicated teams of 5 to 300 people across multiple continents, and Standalone/Full Services for complete project outsourcing. Its technology stack is built around a proprietary digital platform that unifies e-CRF, e-PRO, and connected device data with real-time quality checks, complemented by the Clinical Data Fabric data architecture and the RegIntel AI-powered regulatory compliance tracking solution covering 65 countries and 5 product categories. Certified access to the French National Health Data System (SNDS) and EGB since 2017 enables real-world evidence capabilities that few competitors hold. A dedicated subsidiary, Simelabs, focuses on AI innovation including NLP-based data mapping, document classification, adverse event report processing, and the Skimark Smart Pairing tool for consultant matching.

The revenue model is exclusively professional services and managed services based on quote-based, contract-negotiated pricing. Customers include enterprise pharma (a Top 5 international pharmaceutical company, Celltrion), medical device manufacturers (INSULET, ABBOTT), healthcare technology firms (Resilience), and public-sector/academic institutions (CHU Lille, Strasbourg University Hospitals, French Military Health Service, FAI2R Network). The company holds ISO 27001:2013 and ISO 9001:2015 certifications (since 2017), GDPR compliance, and an EcoVadis sustainability certification (2023), supporting enterprise-level procurement requirements.

Name

ALSINOVA

Legal name

Alsinova

Website

https://alsinova.com

Company type

Private

Founded year

1998

Operating status

Operating

Headcount range

501–1,000 employees

Short description

Alsinova is a France-headquartered global CRO providing end-to-end clinical research services — consulting, FSP, and full-service delivery — to pharmaceutical, biotechnology, medical device, and healthcare institution clients across 26 countries, supported by proprietary AI-powered digital platforms.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) Services

NAICS

Scientific Research and Development Services (5417), Custom Computer Programming Services (541511), Computer Systems Design and Related Services (54151), Other Scientific and Technical Consulting Services (54169), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Computer Integrated Systems Design (7373), Services-Prepackaged Software (7372), Services-Management Consulting Services (8742)

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), Patient Recruitment, Site Feasibility & Trial Enablement CROs (HLAGAAAI), Data Management, Biostatistics & Statistical Programming FSP (HLAGAOAB), Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM), Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL)

Keywords

• Clinical research services
• Contract research organization
• Real-world evidence studies
• Regulatory affairs services
• Pharmacovigilance consulting

Headquarters

HQ city

Boulogne-billancourt

HQ country

France

HQ region

Europe

Offices5 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 Services: End-to-end project management covering the full spectrum from non-clinical/pre-clinical phases to Real-World Evidence, including clinical trials and Early Access Programs. Revenue generated through comprehensive project contracts.
2. Functional Service Provider (FSP): Dedicated teams provided to clients for specific operational needs including statistics, data management, medical writing, and clinical supply. Teams of 5 to 300 people across multiple continents with cost control and business continuity advantages.
3. Consulting Services: Expert resource placement across clinical, RWE, regulatory affairs, vigilance, and quality areas. Uses AI-powered matching tools and rigorous governance for optimal follow-up and long-term success.
4. Standalone Project Services: Individual service offerings including regulatory submissions, site management, monitoring, data management, and medical writing that can be engaged independently.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Core offering

ALSINOVA is a global Contract Research Organization (CRO) delivering end-to-end clinical research services across the entire project lifecycle—from non-clinical/pre-clinical phases through Phase II/III clinical trials, Real-World Evidence (RWE) studies, and Early Access Programs. The company provides specialized service lines including co-design and regulatory, medical writing, clinical operations, data analytics and statistics, SNDS/EGB data services, and vigilance and regulatory affairs. Complementing these services are proprietary AI-driven technology platforms (Clinical Data Fabric, RegIntel, Proprietary Digital Platform, Life Data Science Booster) which enable advanced analytics, automated compliance tracking across 65 countries, and unified eCRF/ePRO/connected device data integration.

Product overview

ALSINOVA is a global CRO driven by AI, offering a comprehensive portfolio of clinical research services and proprietary technology platforms for the life sciences industry. The company provides end-to-end solutions across pharmaceuticals, biotechnology, medical devices, cosmetics, agri-food, veterinary, and healthcare institutions. The core product portfolio consists of ALSINOVA's Proprietary Digital Platform (securing e-CRF, e-PRO, and connected device data integration), RegIntel (AI-powered regulatory compliance tracking across 65 countries), Clinical Data Fabric (flexible data architecture for multi-source data integration), and Life Data Science Booster (ML/AI platform for healthcare analytics). These technology products are complemented by service offerings including Non-Clinical Services, Clinical Trial Services, Early Access Programs, Real-World Evidence Studies, Co-design & Regulatory, Medical Writing, Clinical Operations, Data Analytics & Statistics, SNDS/EGB Data Services, and Vigilance & Regulatory Affairs. ALSINOVA operates globally through three delivery models: Consulting (expert resources), Functional Service Provider (FSP with dedicated teams of 5-300 people), and Standalone/Full Services (full project outsourcing).

Differentiator

Problem solved

Functional benefit

Brands

• Simelabs: Dedicated entity focused on innovation and integration of artificial intelligence, keeping Alsinova at the forefront of technology.

Products and services

• Proprietary Digital Platform Secure, highly customizable digital platform operated by ALSINOVA's own technical team. Unifies e-CRF, e-PRO, and connected device data with real-time advanced data checks, intelligent triggers, and SMS/email capabilities. Hosted on sovereign infrastructure in France to support hybrid and decentralized clinical trials.
• RegIntel AI-powered regulatory intelligence and compliance tracking solution. Automates collection, extraction, structuring, and delivery of compliance data across 65 countries and 5 product categories. Includes an intelligent chatbot for adverse event report processing and regulatory guidance.
• Clinical Data Fabric Flexible and composable data architecture serving as the backbone for leveraging AI and advanced analytics. Integrates data from multiple sources including clinical trials, EHRs, administrative claims, laboratory data, and wearables into a comprehensive patient and operational health data view.
• Life Data Science Booster Machine learning and AI platform for healthcare and clinical trials that orchestrates data, analytics, and technologies to improve patients' lives and facilitate the development of precision therapeutics.
• Non-Clinical/Pre-Clinical Services Data processing and exploration services for pre-clinical research projects including omics and biomarkers analysis, CMC insights, and industrial statistics support for product development across life sciences sectors.
• Clinical Trial Services Comprehensive Phase II & III clinical trial support from study synopsis design to final study report and publication, covering medical support, pharmacovigilance, regulatory affairs, data sciences, and clinical operations across multiple therapeutic areas.
• Early Access Programs (AP1/AP2) End-to-end support for Early Access Programs (AP2) and Compassionate Use (AP1), including program design, execution, compliance management, patient safety monitoring, and treatment efficacy tracking.
• Real-World Evidence (RWE) Studies Hybrid and digitalized real-world studies leveraging healthcare data access (SNDS), patient engagement, methodological expertise, and integrated analytics tools for real-time actionable insights.
• Co-design & Regulatory Services Collaborative design engineering for study protocols, regulatory framework navigation (GDPR, RIPH 2/3, MR001-3/MR004, CNIL), and regulatory submissions (CPP, ANSM, CNIL, Health-Data-Hub).
• Medical Writing Complete medical writing services including protocol writing, CRF/e-PRO development, abstracts, scientific communications, and end-of-study medical reports.
• Clinical Operations Full clinical operations including site management (selection, contracting, payment tracking), monitoring (on-site, RBM, remote), and quality control.
• Data Analytics & Statistics Comprehensive data management and analytics lifecycle from pre-clinical to clinical trials and RWE, featuring automated SAS/R programming, CDISC format support (CDASH-SDTM-ADaM), and methodological expertise including adaptive designs.
• SNDS/EGB Data Services Specialized SNDS data analysis services including EGB exploration, full SNDS analysis, and hybrid e-cohort studies via deterministic or probabilistic matching.
• Vigilance & Regulatory Affairs Comprehensive regulatory affairs and pharmacovigilance services across pharmaceuticals, medical devices, IVDs, cosmetics, and food supplements, covering pre-market and post-market phases with AI-powered compliance tools.

Quantifiable outcome

• <5 days average time before data monitoring
• +4 more outcomes

Named customers9 records

Segments7 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration6 records

AI capability8 records

Feature7 records

Partnerships

Seven partnerships are on record, tiered core, major and minor.

• Astek GroupcoreStrategic or Co-development PartnerAlsinova is the subsidiary of Astek Group offering complete CRO solutions. Astek Group provides global strength and synergy, enabling Alsinova's global coverage across Europe, Asia, America, and Africa with local support capabilities.
• SimelabscoreTechnology or IntegrationDedicated entity focused on innovation and integration of artificial intelligence. Simelabs keeps Alsinova at the forefront of technology and enables anticipation of future client needs through AI-driven solutions.
• Keyrus Life SciencemajorStrategic or Co-development PartnerCollaboration partner in large-scale RWE studies. Keyrus Life Science conducted activities for studies including regulatory submissions, recruitment, monitoring, data management, and statistical analyses.
• UnknownsminorImplementation/ SI/ Consulting PartnerUser testing partner for pre-testing campaigns (user testing) to validate use cases and improve experience through sociological approaches.
• Beslay Law FirmminorImplementation/ SI/ Consulting PartnerLegal partner for contract validation, particularly for investigator site contract negotiations under tight deadlines.
• AFCROs (Real World Data group)minorStrategic or Co-development PartnerMember of AFCROs Real World Data group and REDSIAM, demonstrating expertise in real-world evidence and epidemiological studies.
• REDSIAMminorStrategic or Co-development PartnerMember of REDSIAM organization for epidemiological data expertise and real-world data research collaboration.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Worldwide Clinical Trials: Worldwide Clinical Trials is a mid-sized global CRO with strong CNS, cardiometabolic and rare-disease expertise and a meaningful FSP offering. Comparable to Alsinova on scale, therapeutic focus, and enterprise pharma customer mix.
• PSI CRO: PSI CRO is a privately held, mid-sized full-service CRO with European roots and global operations across oncology, rare disease and cell/gene therapy. Its size, therapeutic breadth and FSP offering closely mirror Alsinova's positioning.
• Medpace: Medpace is a mid-sized, full-service CRO focused on Phase II/III trials across metabolic, oncology, cardiovascular and rare-disease areas, with strong European presence. Highly comparable in operating model, therapeutic breadth and target mid-market to enterprise sponsors.

Regional players

• Biotrial: Biotrial is a France-based CRO with strong capabilities in early-phase clinical trials and CNS, alongside broader clinical and biometric services. Comparable to Alsinova on French-headquartered CRO positioning and European enterprise pharma client base.

Broad incumbents

• Parexel International: Parexel is a global, full-service CRO with deep expertise across Phase II/III trials, real-world evidence, and regulatory consulting. Its broad therapeutic-area reach and biopharma customer base make it a directly comparable incumbent to Alsinova's full-service offering.
• IQVIA: IQVIA is the largest global CRO and clinical research services provider with end-to-end Phase I-IV capabilities, real-world evidence, and technology platforms (e.g., EDC, CTMS, analytics). It is the primary scaled incumbent against which Alsinova competes for enterprise pharma and biotech sponsors.
• Labcorp Drug Development (Fortrea): Labcorp's clinical development business (now Fortrea) provides global CRO services plus central laboratory capabilities. Comparable to Alsinova on multi-continent clinical operations and biospecimen/data integration across trials.
• Syneos Health: Syneos Health is a global biopharmaceutical solutions provider offering clinical development, FSP and commercial services. Directly comparable on FSP model scale and global clinical delivery that Alsinova markets to enterprise sponsors.
• ICON plc: ICON plc is a top-tier global CRO offering full-service clinical development, FSP, laboratory, and decentralized trial solutions across all major therapeutic areas. Post-PRA Health it serves as a direct benchmark for Alsinova's full-service and FSP delivery models.

Emerging players

• Keyrus Life Science: Keyrus Life Science is a European-focused CRO and data analytics specialist with overlapping RWE, biostatistics and regulatory capabilities. Documented as a collaboration partner in Alsinova's large-scale RWE studies, indicating direct overlap in European real-world evidence work.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/alsinova

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 ALSINOVA