Clininfo

What Clininfo does

ClinInfo SAS is a privately held European eClinical SaaS provider founded in 1998 as a spin-off of the Clinical Pharmacology Service of Université Lyon 1 (France). The company designs, develops, and hosts an integrated suite of six regulatory-grade applications covering the clinical trial lifecycle: eCRF (electronic Case-Report Form) for investigator data capture, ePRO (electronic Patient-Reported Outcome) for patient self-reporting, eTMF (electronic Trial Master File) for document management, IWRS (Interactive Web-Response System) for randomization and investigational product management, CDMS (Clinical Data Management System) with built-in MedDRA/WHO Drug/IMDRF coding, and CTMS (Clinical Trial Management Software) for operational oversight. The platform is GAMP 5 validated, deployed on dedicated servers in certified data centers in Lyon (HDS, ISO-27001) and Pittsburgh (SOC 1/2 Type II, ISO-27001), and is documented to comply with 21 CFR Part 11, GMP Annex 11, ICH GCP, GDPR, ISO-14155, and HIPAA, with public API endpoints for sponsor and CRO integration.

ClinInfo monetizes the platform through quote-based, project-specific multi-year SaaS subscriptions whose price scales with study parameters (countries, patients, CRF pages, modules selected), supplemented by customization, configuration, and integration services billed as part of project setup. Go-to-market is enterprise-led, primarily direct sales targeting pharmaceutical and biotech sponsors, contract research organizations (CROs), medical device companies, and academic medical centers; lead generation runs through the company website, an online project estimator, and a request-a-demo CTA. The named customer base includes Novartis, Roche, Gilead, Astellas, AbbVie, Ipsen, ICON, IQVIA, PPD (Thermo Fisher), Diabeloop, Centre Léon Bérard / Unicancer, AP-HP, HCL, and INSERM, with deployments reported in more than 50 countries. The company remains privately held, has no disclosed external funding, is registered as a Société par Actions Simplifiée with €64,000 of share capital, and lists 1-10 employees in the firmographic record.

Name

Clininfo

Legal name

ClinInfo SAS

Website

https://clininfo.fr

Company type

Private

Founded year

1998

Operating status

Operating

Headcount range

1–10 employees

Short description

ClinInfo SAS, founded in 1998 in Lyon, France, provides an integrated, GAMP 5-validated eClinical SaaS suite (eCRF, ePRO, eTMF, IWRS, CDMS, CTMS) for clinical trials, serving pharmaceutical, biotech, CRO, medical device, and academic customers across more than 50 countries via EU and US certified data centers.

Ownership category

akta.pro rank

Product category

Clinical Trial Management Software

NAICS

Software Publishers (513210)

SIC

Services-Prepackaged Software (7372)

akta.pro primary industry

Site & Investigator Platforms (Site Payments, Feasibility, Activation) (HLACAOAJ)

Keywords

• EClinical software
• Clinical trial management
• Electronic data capture
• Clinical data management
• Patient reported outcomes

Headquarters

HQ city

Lyon

HQ country

France

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

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

Revenue model

1. eClinical SaaS Platform Subscription: ClinInfo develops and provides eClinical solutions in SaaS mode including data hosting. The company offers a modular platform where multiple applications (eCRF, ePRO, IWRS, CDMS, eTMF, CTMS) can be used standalone or together. Services include customization, hosting, user support, and quality assurance. Pricing is quote-based and project-specific, adapting to study complexity, number of countries, patients, and CRF pages.
2. Custom Development and Configuration Services: IT specialists and data managers provide project analysis and customization services throughout the complete lifecycle, including visual customization (logos, graphical tuning), data flow configuration (monitoring, electronic signature, vigilance processes), email alerts, and custom reports.
3. API and Integration Services: Applications can be configured to use API for connections with client IT infrastructure, enabling automated data transfer, periodical synchronization, and progress reports - billed as part of project setup or ongoing service.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

ClinInfo designs, develops, and delivers a modular eClinical SaaS platform for clinical trials, registries, and epidemiological studies. The platform consists of six interconnected applications—eCRF for investigator data capture, ePRO for patient-reported outcomes, IWRS for randomization and IMP management, CDMS for data management and coding, eTMF for document management, and CTMS for trial oversight—delivered as a hosted SaaS service from certified data centers in France and the United States, with customization, hosting, user support, and quality assurance included.

Product overview

ClinInfo offers a suite of six interconnected eClinical applications: eCRF (electronic Case-Report Form) for investigator data entry, ePRO (electronic Patient-Reported Outcome) for patient self-reporting, IWRS (Interactive Web-Response System) for randomization and IMP management, CDMS (Clinical Data Management System) for centralized data cleaning and coding, eTMF (electronic Trial Master File) for document management, and CTMS (Clinical Trial Management Software) for monitoring and operational oversight. These modules are designed to be used as standalone solutions or together as a fully synchronized ecosystem, sharing data in real-time across the platform.

Differentiator

Problem solved

Functional benefit

Products and services

• eCRF (electronic Case-Report Form) Electronic data capture system enabling investigators to enter patient data directly into clinical study databases, with built-in edit checks, query management, risk-based monitoring, and automated safety alerts for adverse events. Targeted at investigators and data managers in pharmaceutical, biotech, CRO, and academic clinical trials.
• ePRO (electronic Patient-Reported Outcome) Patient-friendly electronic questionnaire system for remote data capture, supporting licensed patient-reported outcome instruments with built-in scoring, eConsent workflows, and real-time synchronization with eCRF. Targeted at clinical trial patients, investigators, and study coordinators.
• IWRS (Interactive Web-Response System) Randomization and investigational medicinal product (IMP) management system supporting flexible randomization lists, stratification, multi-arm studies, minimization algorithms, and real-time stock tracking. Targeted at clinical operations and supply chain teams running randomized trials.
• CDMS (Clinical Data Management System) Centralized data management platform with Excel-based CRF configuration, built-in medical coding (MedDRA for adverse events, WHO Drug for concomitant medications, IMDRF for devices), flexible reporting, and CDISC/CDASH compliant exports. Targeted at data managers and biostatisticians in clinical research organizations.
• eTMF (electronic Trial Master File) Digital document management system for organizing, uploading, and tracking essential trial documents with configurable quality control, version management, and TMF Exchange Mechanism standard exports. Targeted at trial master file managers, regulatory affairs, and clinical operations teams.
• CTMS (Clinical Trial Management Software)

Quantifiable outcome

• 99%+ platform availability across EU and US data centers
• +3 more outcomes

Named customers20 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

Yes

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Five partnerships are on record, tiered core, notable and foundational.

• University College CorkcoreStrategic or Co-development Partner · 1 January 2012ClinInfo was part of a 12-organization consortium for the SENATOR European Union financed project (2012-2018) on optimizing drug treatments for senior people. ClinInfo drove the Data Management pole and contributed significantly to developing procedures related to the clinical trial. Project concluded in May 2018 with promising results.
• Paris Public Hospital Assistance (AP-HP)notableStrategic or Co-development Partner · 1 January 2012ClinInfo regularly works with Paris Public Hospital Assistance (AP-HP) as part of its international collaboration strategy, providing eClinical solutions for research projects.
• DiabeloopnotableStrategic or Co-development Partner · 1 January 2011ClinInfo partnered with Diabeloop (spun off from CERITD research project led by Dr. Charpentier) to support clinical trials and data collection for automated insulin delivery system for Type 1 diabetes. Between 2011-2017, up to 6 clinical trials were set up. Project culminated in Diabeloop receiving CE marking approval in 2018.
• Centre Léon Bérard / UnicancercoreStrategic or Co-development Partner · 1 January 1998Since the late 1990s, ClinInfo has accompanied Centre Léon Bérard and the Unicancer group in multiple research projects including interventional and non-interventional studies, large randomized trials, and feasibility studies. The partnership has contributed to constant improvement of ClinInfo's solutions.
• Université Lyon 1foundationalStrategic or Co-development Partner · 1 January 1998ClinInfo originated from the Clinical Pharmacology Service of Université Lyon 1 (France), led by Pr. Jean-Pierre Boissel. This academic foundation provides the company with methodological expertise and continuous research collaboration.

Scale indicators7 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Medidata Solutions (Dassault Systèmes): Medidata's Rave EDC, eCOA/ePRO, CTMS, RTSM, and eTMF offerings overlap directly with ClinInfo's six-module suite, serving the same pharma, biotech, and CRO buyer base globally.
• Clinical Ink: Clinical Ink's SureSource Engage platform delivers eCOA/ePRO, eConsent, and EDC capabilities that overlap with ClinInfo's ePRO and eCRF modules, targeting the same pharmaceutical and CRO customers.
• ArisGlobal: ArisGlobal offers a unified clinical trial platform including EDC, CTMS, eTMF, and safety/RTSM modules, directly comparable in scope and buyer target to ClinInfo's integrated eClinical suite.
• Veeva Systems: Veeva's Vault CDMS, Vault EDC, and Vault CTMS compete head-to-head with ClinInfo across pharmaceutical sponsors and CROs; it is the largest pure-play cloud eClinical vendor and a direct competitor in clinical data capture and trial management.
• OpenClinica: OpenClinica offers EDC and ePRO modules plus a CDMS aimed at clinical research; it competes with ClinInfo on enterprise-grade validated EDC for sponsors and CROs, especially in academic and translational research.

Emerging players

• Formedix: Formedix provides CDISC standards automation, EDC build, and clinical metadata repository solutions that overlap with ClinInfo's CDMS/CDISC-compliant exports and clinical trial configuration services.
• Castor EDC: Castor provides an EDC platform with ePRO and eConsent capabilities aimed at academic and commercial clinical trials; it competes with ClinInfo particularly in the academic and mid-sized European sponsor segments.
• Veeva Vault ePRO / eCOA providers (YPrime / CRF Health): YPrime (and the merged CRF Health legacy) specialize in eCOA/ePRO for clinical trials, a module that directly competes with ClinInfo's ePRO offering for sponsors and CROs running patient-reported outcome studies.

Broad incumbents

• Oracle Clinical One: Oracle's Clinical One platform provides unified EDC, RTSM, ePRO, and CTMS capabilities similar to ClinInfo's suite, but as part of Oracle's much broader life-sciences and enterprise software portfolio targeting the same sponsors.

Regional players

• PHARMASEAL / Ennov (clinical suite): Ennov offers a CTMS/EDC/eTMF platform with strong European presence and validated regulatory compliance, competing with ClinInfo for EU-based sponsors and CROs requiring data residency.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/clininfo

Compliance10 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 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 Clininfo