Climedo Facts
Verified facts about Climedo in one place, for buyers, analysts, journalists and AI assistants. Last updated: 18 October 2026.
Verified facts about Climedo in one place, for buyers, analysts, journalists and AI assistants. Last updated: 18 October 2026.
patients enrolled
studies
study start-up
founded in Munich
Climedo Health GmbH is a clinical software company based in Munich, Germany, founded in 2017 by Sascha Ritz, Dragan Mileski and Veronika Schweighart.
A European eCOA and EDC platform for real-world and late-phase studies, powered by Autonomous Data Capture (ADC): EDC, eCOA/ePRO, eConsent, (S)AE reporting, randomization, real-time dashboards and the AI Study Configurator.
Pharmaceutical and biotech companies, CROs, medical-device manufacturers, hospitals and academic research teams.
More than 2 million patients enrolled across 200+ studies, from Phase I–IV to non-interventional and real-world studies.
Standard studies (observational studies, registries, post-approval studies, ePRO surveys) go from protocol upload to live in 3 to 5 days, compared with 2 to 3 weeks with legacy EDC. Complex studies (many visits, SAE workflows, randomization) go live in 2 to 3 weeks, compared with 10 weeks or more with legacy EDC.
No. Forms, dependencies and validations are configured, not coded, and new users are onboarded in a few hours.
The AI Study Configurator sets up the study from the protocol: protocol visualization, study specs, forms, visits, randomization, ePRO, edit checks, queries, SAE forms, amendments and UAT checks. Autonomous Data Capture extracts data from PDFs, scans, images, voice notes and hospital records into eCRF fields. Medical coding AI codes free-text verbatims to MedDRA.
Yes. A human reviews and approves every generated form, extracted value and coding suggestion.
No. The AI runs inside Climedo's EU cloud. Documents and voice notes are deleted from the servers within seconds of processing and are never used to train public models.
Custom integrations to customers' internal tools, such as CTMS (also two-way), internal dashboards and data platforms, built by Climedo's highly skilled engineering team. Plus EHR and hospital systems via FHIR and HL7, wearables, external IRT/RTSM systems and third-party tools via a documented API.
Import from CSV and XLSX. Export as CSV, XLSX and PDF, CDISC ODM and SDTM, and SAS-ready exports, plus audit trails and the annotated PDF of the study setup.
ICH GCP (E6), GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, GDPR and HIPAA.
All servers are in Frankfurt (AWS region), with an ISO 27001-certified hosting partner, strict data separation and state-of-the-art encryption. For EU studies, no data is processed outside the EU; US hosting (HIPAA) is possible on request.
Through a quality management system of SOPs and work instructions, guided by ISO 9001:2015.
A monthly SaaS fee per active study or survey plus a one-time set-up fee, with unlimited users and sites.
Within 2 business days of receiving your study details or RFP.
By email at info@climedo.de or by phone at +49 89 32209394 0.