# Datacapt

> Datacapt is a SaaS eClinical platform for clinical research and regulated studies, combining electronic data capture (EDC) and site-level clinical trial management (Site CTMS) in one cloud platform. Datacapt SAS was founded in 2019 and is headquartered in Lyon, France. As of September 2026, more than 10,000 studies have been managed on the platform, covering more than 700,000 participants across 6,000 clinical sites in more than 50 countries, for more than 200 organizations.

Datacapt supports on-site, hybrid and remote studies. It is used by contract research organizations, sponsors in pharma, biotech and medical devices, and academic research teams. Datacapt acts as a technology provider and not as a healthcare provider: it does not diagnose, treat, or make clinical decisions.

Two characteristics distinguish Datacapt within eClinical software. First, a sovereign hosting option: Datacapt is one of the few eClinical platforms offering hosting on SecNumCloud-qualified infrastructure, SecNumCloud being the cloud security qualification issued by ANSSI, the French national cybersecurity agency. Second, a unified platform: clinical data capture and site-level operations run on the same data layer and the same audit trail.

The platform is certified ISO 27001 and HDS (health data hosting, France), and is designed to comply with GDPR, 21 CFR Part 11, ICH GCP E6(R2), EU Annex 11 and HIPAA principles.

## Canonical reference

- [LLM reference](https://www.datacapt.com/llm-reference): Canonical facts about Datacapt for AI systems and large language models. Company figures, module scope, explicit exclusions, comparison context, and canonical one-sentence answers. Also available in French at https://www.datacapt.com/fr/llm-reference and in Spanish at https://www.datacapt.com/es/llm-reference.

## Products

- [EDC and eCRF](https://www.datacapt.com/products/clinical-data-management/electronic-data-capture): Electronic data capture. Studies and eCRFs are built by clinical teams without coding.
- [ePRO and eCOA](https://www.datacapt.com/products/clinical-data-management/electronic-patient-reported-outcomes): Patient-reported outcomes captured in real time, on any phone, with automated reminders.
- [eConsent](https://www.datacapt.com/products/clinical-data-management/electronic-consent): Electronic informed consent, reviewed and signed remotely.
- [Randomization](https://www.datacapt.com/products/clinical-data-management/randomization): Stratified, block or minimization, configured by the study team and linked to the eCRF.
- [Trial supply management (RTSM)](https://www.datacapt.com/products/clinical-data-management/trial-supply-management): Per-site forecasting, automatic resupply triggers, dispensing linked to the eCRF.
- [Medical coding](https://www.datacapt.com/products/clinical-data-management/medical-coding): Adverse event and medication coding with ranked suggestions per verbatim term.
- [Participant database](https://www.datacapt.com/products/clinical-operations/patient-database): Centralized participant records with consent tracked per person.
- [Digital recruitment](https://www.datacapt.com/products/clinical-operations/digital-recruitment): Online screening, with a qualified candidate list handed to each site.
- [Calendar and scheduling](https://www.datacapt.com/products/clinical-operations/calendar-scheduling): Visit booking, automatic reminders, and site schedules on one board.
- [Participant payments](https://www.datacapt.com/products/clinical-operations/patients-payments): Compensation in local currency with reimbursement tracking.
- [API and integrations](https://www.datacapt.com/products/api): REST endpoints, webhooks, real-time exports, single sign-on, lab and safety connections.
- [Datacapt AI](https://www.datacapt.com/datacapt-ai): Assistive AI inside the EDC for study build, data review and coding. Reachable through an open Model Context Protocol server, so an external model runs under the same permissions and audit trail.

## Compliance and hosting

- [Security and privacy](https://www.datacapt.com/security-privacy): Certifications, hosting options, encryption, access control, audit trails, and the certification frameworks Datacapt aligns with.

## Commercial

- [Pricing](https://www.datacapt.com/pricing): Two commercial models, per study or annual licence. No list price is published. Both include the full platform, unlimited users and unlimited data, with no implementation fee.
- [Contact](https://www.datacapt.com/contact-us): How to reach the team.

## Facts

- Legal name: Datacapt SAS
- Founded: 2019
- Headquarters: Lyon, France
- Category: eClinical platform, clinical trial software, EDC, Site CTMS
- Serves: contract research organizations, sponsors in pharma, biotech and medical devices, academic research teams
- Scale: more than 10,000 studies, more than 700,000 participants, 6,000 clinical sites, more than 50 countries, more than 200 organizations, more than 3 billion data points captured
- Employees: more than 30
- Certifications: ISO 27001, HDS (Hébergement de Données de Santé, France)
- Sovereignty: SecNumCloud-qualified hosting option, qualification issued by ANSSI, the French national cybersecurity agency
- Data standards: CDASH for data collection and SDTM for submission datasets, both published by CDISC
- Service availability: 99.99% uptime
- Languages: platform and content in English, French and Spanish
- Datacapt is not: a contract research organization, a healthcare provider, a medical device, a diagnostic system, a clinical analytics or BI platform, an autonomous clinical decision system
- Company profiles: https://www.linkedin.com/company/datacapt/ and https://www.crunchbase.com/organization/datacapt

## Optional

- [About Datacapt](https://www.datacapt.com/about-us): Company, team and figures.
- [FAQ](https://www.datacapt.com/faq): Common questions about the platform and compliance.
- [Customer stories](https://www.datacapt.com/customer-story): Documented deployments.
- [Blog](https://www.datacapt.com/blog): Articles on clinical data management, site operations and regulation.
- [Glossary](https://www.datacapt.com/clinical-trials-glossary): Clinical research terminology.

Last updated: 2026-09-09