What Randomized Clinical Trials does

RCTs (Randomized Clinical Trials) is a French full-service Contract Research Organization headquartered in Lyon, founded in 1989 by Alain Baleydier and Jean Sylvain Larguier. The company delivers clinical research services across the entire development lifecycle for pharmaceutical, biotechnology, medical device/medtech manufacturers, and academic sponsors, including pre-authorization studies, post-authorization primary data studies, secondary data studies using French national health databases (SNDS), early access/compassionate use programs, and medical device clinical evaluation under EU Regulation 2017/745. The company is organized around a core team supported by a network of 440 regional experts and 13 offices spanning Europe, North America (US, Canada), South America (Brazil), and Africa, with direct shareholder involvement on projects as a differentiating positioning versus larger CROs. RCTs holds Qualiopi training certification and has obtained EcoVadis Bronze recognition for ESG practices.

The company's technical stack centers on ClinInfo, a modular eClinical platform co-founded by RCTs in 1998, which provides eCRF, eTMF, ePRO, IVRS/IWRS, CDISC-compliant data management, and API connectors, validated to 21 CFR Part 11, GAMP 5, EU GMP Annex 11, and ISO 14155:2012, and deployed on ISO 27001-certified health data hosting. RCTs also conducts CTIS regulatory submissions for EU clinical trials and applies machine learning methods (predictive modeling, missing-data imputation, synthetic data generation via GANs/SMOTE/CTGAN, unsupervised clustering) within its pharmaco-epidemiology work. Revenue is generated primarily through professional services engagements on a quote-based, project-scoped model, supplemented by subscription/recurring revenue from the ClinInfo digital platform and Qualiopi-certified training services.

In 2025, RCTs completed an ownership transition: Frédéric Mistretta became majority shareholder and President, and four senior executives (Morgane Champiot, Audrey Lajoinie, Didier Not, Flavien Roux) entered the capital, while Siparex divested and the founding partners stepped down after 30 years. The same year, RCTs formed a strategic partnership with LyREC to extend site engagement capabilities and joined the Lyonbiopôle health competitiveness cluster to deepen biotech/medtech visibility. Named enterprise customers include Sanofi, Novartis, Amgen, W.L. Gore, RegenLife, and Novastep (now Enovis Foot & Ankle), with the company also collaborating with DNDi on neglected-disease programs.

Name

Randomized Clinical Trials

Legal name

RCTs

Website

https://rcts.fr

Company type

Private

Founded year

1989

Operating status

Operating

Headcount range

251–500 employees

Short description

RCTs is a Lyon-based, full-service Contract Research Organization founded in 1989 that delivers clinical research, real-world evidence, and regulatory services to pharmaceutical, biotech, medical device, and academic sponsors across Europe, the Americas, and Africa.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) Services

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (54171), Professional, Scientific, and Technical Services (541)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Medical Writing & Regulatory Submission Support CROs (HLAGAAAG), Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH)

Keywords

• Clinical research services
• Contract research organization
• Medical device evaluation
• Pharmacoepidemiology studies
• Eclinical solutions

Headquarters

HQ city

Lyon

HQ country

France

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Clinical Research Services: Full-service CRO offering comprehensive clinical research services from study design to clinical report writing, including monitoring, statistical analysis, data management, regulatory submissions, and post-authorization studies
2. Digital Solutions / Software: Customizable eClinical software solutions including eTMF, eCRF, IVRS/IWRS, and data management tools provided through ClinInfo partnership
3. Regulatory Consulting: Regulatory consulting for medical devices including CE marking, European Regulation 2017/745 compliance, clinical evaluation reports
4. Training Services: Training services under Qualiopi certification for clinical research professionals

Go-to-market motion2 records

Distribution channels3 records

Marketing channels6 records

Core offering

RCTs is an international full-service Contract Research Organization (CRO) providing end-to-end clinical research services from study design to clinical report writing, including monitoring, statistical analysis, data management, regulatory submissions, and post-authorization studies for pharmaceutical, biotech, medtech, medical device, and academic sponsors. The offering is complemented by the ClinInfo eClinical digital solutions platform (eCRF, eTMF, ePRO, IVRS/IWRS, CDM, API connectors) co-founded by RCTs in 1998, plus dedicated expertise in French SNDS database pharmaco-epidemiology and EU CTIS / EU 2017/745 medical device regulatory consulting.

Product overview

RCTs is an international full-service CRO (Contract Research Organization) headquartered in Lyon, France, with over 35 years of experience. The company offers a comprehensive portfolio spanning clinical trial services across the entire drug and medical device development lifecycle. Its core offerings include pre and post-authorization clinical studies, secondary data studies using French healthcare databases (SNDS), medical device evaluation and regulatory consulting, and international study support. The portfolio includes the ClinInfo digital platform (co-founded by RCTs in 1998), providing modular eClinical software with eCRF, eTMF, ePRO, IVRS/IWRS, and API connectors. RCTs serves pharmaceutical companies, biotechs, medtechs, and academic sponsors across Europe, North America, South America, and Africa through a network of 440 regional experts and 13 offices.

Differentiator

Problem solved

Functional benefit

Products and services

• Pre-Authorization Clinical Studies Full clinical research services supporting drug and medical device development prior to regulatory approval, including study design, execution, monitoring, statistical analysis, and clinical report writing for pharmaceutical, biotech, and medtech sponsors.
• Post-Authorization Studies on Primary Data Post-marketing studies using primary data collection methods to evaluate drug and medical device products after market entry, including real-world evidence generation, interventional and non-interventional designs.
• Secondary Data Studies (RNIPH / SNDS) Studies leveraging existing French healthcare databases including SNDS (Système National des Données de Santé), registries, and medico-administrative databases for pharmacoepidemiology, real-world evidence, and health economics research.
• Early Access / Compassionate Use Programs Support for early access and compassionate use pathways, including French ATU (Autorisation Temporaire d'Utilisation) cohort programs such as the DARATUMUMAB cohort ATU, bridging real-world data collection with pre-approval access.
• Medical Device Clinical Evaluation & Regulatory Consulting Clinical evaluation services for medical device compliance with European Regulation 2017/745, including Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), CE marking support, and Notified Body interactions for implantable and active devices.
• Biotech & Medtech Clinical Development Support Specialized CRO services tailored for biotech and medtech companies, providing flexible, agile partnership with high-level expertise across clinical investigation, regulatory strategy, and market access to support fundraising and product development.
• CTIS Regulatory Submission Services European Clinical Trials Information System (CTIS) submission services including initial clinical trial application submissions, Request for Information (RFI) responses, authorization management, and post-authorization declarations for EU clinical trials.
• International Clinical Studies Full-service international CRO capabilities with 440 regional experts and 13 offices across Europe, North America, South America, and Africa, supporting interventional and non-interventional trials across all study types and therapeutic areas.
• Qualiopi-Certified Training Services Qualiopi-certified training programs for clinical research professionals covering clinical trial methodology, regulatory compliance, biostatistics, and CDISC standards, delivered under the French national quality reference framework.
• ClinInfo Digital eClinical Platform Modular eClinical software platform co-founded by RCTs in 1998, offering IVRS/IWRS modules, coding tools, Clinical Data Management, eTMF, eCRF/pCRF, ePRO, API connectors, and pseudonymized medical imaging upload; validated per 21 CFR Part 11, GAMP 5, EU GMP Annex 11, and ISO 14155:2012; deployed on ISO 27001-certified hosting.

Quantifiable outcome

• 96% success rate at 18 months for sleeping sickness treatment (acoziborole)
• +4 more outcomes

Named customers7 records

Segments5 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability6 records

Feature4 records

Partnerships

Ten partnerships are on record, tiered core and minor.

• LyRECcoreStrategic or Co-development Partner · 20 November 2025Strategic partnership between LyREC and RCTs combining their complementary expertise in clinical research. LyREC brings field facilitation and site engagement capabilities while RCTs contributes interventional study expertise. Together they cover the full clinical research value chain for biotech, medtech, pharmaceutical, and academic clients. Partnership aims to accelerate clinical study timelines through proximity to investigator physicians.
• ClinInfocoreTechnology or Integration · 1 January 1998Co-founded by RCTs in 1998, ClinInfo is a Lyon-based company specializing in eClinical solutions. ClinInfo provides validated digital solutions (21 CFR Part 11, Gamp5, EU GMP Annex 11, ISO14155:2012) for clinical trials including eTMF, eCRF, IVRS/IWRS. Deployed on ISO-27001 certified hosting infrastructure.
• LyonbiopôleminorOthersHealth competitiveness cluster in Auvergne-Rhône-Alpes region. RCTs membership provides visibility in biotech/medtech sector and opportunities for collaboration, strategic monitoring, and project participation.
• DNDi (Drugs for Neglected Diseases initiative)coreStrategic or Co-development PartnerCollaboration on acoziborole Phase II/III study for sleeping sickness (human African trypanosomiasis). DNDi developed the drug; RCTs contributed data management and statistical analysis expertise. Study achieved 96% success rate and received EMA positive opinion.
• SanoficoreStrategic or Co-development PartnerCollaboration with Sanofi on acoziborole development for sleeping sickness treatment. Sanofi partnered with DNDi on this neglected disease program. RCTs provided clinical operations support contributing to EMA authorization of single-dose treatment.
• NovartiscoreStrategic or Co-development PartnerNovartis serves as Data Controller for multiple RCTs-conducted studies including SOLAIR (omalizumab in severe asthma, 19,203 patients) and TFR-CP-CML (tyrosine kinase inhibitor patterns in CML). RCTs acts as Data Processor.
• W.L. GOREcoreStrategic or Co-development PartnerRCTs conducted post-registration study (GORE-EPI) using SNDS database to evaluate real-life outcomes of GORE EXCLUDER Iliac Branch Endoprosthesis. Demonstrated 84%/79% event-free survival at 1/2 years.
• Novastep (now Enovis Foot & Ankle)coreStrategic or Co-development PartnerRegulatory consulting partnership for clinical evaluation compliance with European Regulation 2017/745. RCTs validated 6 technical documentation files with clinical portion approved by Notified Body for implantable medical devices.
• AmgencoreStrategic or Co-development PartnerAmgen served as Data Controller for SNDS-PMO study on osteoporosis treatment discontinuation in 128,980 postmenopausal women. RCTs conducted pharmaco-epidemiological analysis demonstrating 92% increased fracture risk with denosumab discontinuation.
• KPMGminorImplementation/ SI/ Consulting PartnerProfessional services firm (Cédric Peyre, Laurent Coynel, Nicolas Huet) that advised on RCTs shareholder transition and ownership evolution.

Scale indicators7 records

Recent moves7 records

Expansion highlights4 records

Direct peers

• PSI CRO: Privately held, Switzerland-based full-service CRO covering Phase I–IV globally. Comparable to RCTs in mid-size positioning, full-service delivery, and biotech/pharma client focus, with broader global reach across Eastern Europe and the Americas.
• Cromsource: European-headquartered, privately held full-service CRO serving pharma, biotech, and medical device sponsors. Comparable to RCTs in mid-size positioning and European footprint, with a wider device and vaccine focus.
• Medpace: Profitable, mid-size US-headquartered full-service CRO. Closely comparable in operating model — full-service Phase I–IV with strong sponsor relationships — though larger and focused on biotech. RCTs serves a similar mid-size CRO niche in Europe with an analogous biotech/medtech emphasis.
• Worldwide Clinical Trials: Privately held, mid-size global CRO focused on complex Phase II–III and post-approval studies across multiple therapeutic areas. Comparable to RCTs in size, end-to-end service model, and pharma/biotech customer base, with a slightly broader North American footprint.
• Biotrial: French-based CRO headquartered near Rennes offering full-service early-phase clinical research. Direct geographic and product peer to RCTs, both serving EU pharma/biotech with full-service clinical offerings; complementary in early-phase strength versus RCTs' SNDS / post-marketing focus.
• Ergomed (now part of Premier Research): Mid-size CRO with strong pharmacovigilance, rare disease, and post-marketing capabilities before its acquisition. Peer to RCTs in size, full-service model, and emphasis on specialty therapeutic areas and PV / real-world evidence.

Broad incumbents

• Parexel International: Major global CRO (owned by EQT and Goldman Sachs Asset Management). Competes with RCTs on full-service clinical trials and regulatory consulting (especially medtech and EU MDR support), with substantially deeper resources and broader footprint.
• IQVIA: World's largest CRO / clinical-services provider with unmatched geographic and therapeutic breadth. Competes against RCTs on the same pharma/biotech RFPs, but serves as a broader incumbent whose portfolio spans R&D solutions, real-world evidence, and technology platforms well beyond what RCTs offers.
• Charles River Laboratories: Large CRO and preclinical services provider with a meaningful clinical services segment through its RMS / CDMO businesses. Provides broader, integrated drug-development services overlapping with RCTs' Phase I–IV offering, particularly for European biotech sponsors.
• ICON plc: Global full-service CRO formed via the PRA Health Sciences combination, with deep Phase I–IV and post-approval capabilities. Overlaps with RCTs in EU regulatory trial execution and post-marketing studies, but operates at far greater scale across all geographies.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/rcts_fr
• LinkedInlinkedin.com/company/rcts

Compliance8 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Randomized Clinical Trials