Most clinical data still reaches the eCRF because it was entered manually. Autonomous Data Capture (ADC) brings study data straight from sources such as documents, scans, voice and connected systems into the EDC, instead of typing it in by hand. People review and confirm, and every step stays traceable. The result is higher data quality with less effort for the sites.
AI-assisted import from screenshots, doctor's letters and other source documents.
In most real-world and late-phase studies, data still reaches the eCRF by hand, transcribed from paper, PDFs, EHR or other clinical documents. That manual step costs time, quality and speed.
Study data flows into your EDC in three stages, with no manual data entry. Instead of re-keying, Climedo captures unstructured eSource and turns it into structured study data, always following the human-in-the-loop principle.
Data originates without manual entry.
AI structures the unstructured.
Human-approved import, with the groundwork done by AI.
Three sources flow into one engine, and out as real-time insight.
12 fields extracted
14 rows prefilled
EQ-5D-5L · 5 answers
PDFs, scans, screenshots and clinical-record exports, read and structured automatically.
ePRO, voice, scan and EHR export, captured on any device, no app required.
Structured forms and smart import, straight from the site, without re-keying.
AI-assisted extraction · human-in-the-loop review · full audit trail. Every data point is captured, validated and traceable, near-zero manual entry, EU-hosted, MDR/GCP-ready.
Efficacy and safety signals reach healthcare professionals and key opinion leaders as the study runs, turning data collection into scientific dialogue, not a year-end report.
The ADC engine is three capabilities working as one pipeline: AI Study Configurator sets the study up, Photo Capture brings source data in, and AI Medical Coding structures it, each with a human in the loop.
DIAGNOSIS
Type 2 diabetes mellitus, ICD-10 E11.9
MEDICATION ON DISCHARGE
LABORATORY
VITAL SIGNS
Your patients' health data in three clicks. Photograph or screenshot a lab report, doctor's letter or EHR record on your phone and stream it straight into Climedo. AI extracts the eCRF fields and pre-fills the form for you to review. Photos are not stored, the AI runs on Climedo's EU servers, and your data is never used to train public AI models.
Scan the QR code in the EDC with your phone.
PDFs, images or voice notes, straight from your phone.
AI-extracted data appears in the EDC, ready for review.
Automation helps where time is most valuable: at the study sites.
With fast data transfer into the eCRF, you can follow recruitment in real time.
Validated at the source: the four-eyes principle of AI and healthcare professionals helps prevent data-entry errors.
Protocol to live study in days, not weeks.
The AI visualizes your study protocol, turns it into study specifications and generates the study in Climedo: forms, visits, randomization, ePRO, edit checks, queries and SAE forms. Protocol changes follow the same path as reviewed amendments. What once took two to three weeks now takes three to five days, from protocol upload to live study.
MedDRA coding with a human in the loop.
The moment a site submits a free-text field, the verbatim is queued for coding, with no manual export. Coders keep full context, from patient ID and SAE reference to form name and table row, one click away, and every suggestion carries a confidence score. Compound verbatims are auto-split into individual terms, each coded, reviewed and linked as siblings. Verbatims are anonymised before processing and never used to train public AI models.
ADC is the sites’ AI assistant, but it never makes a decision for them. Every extraction is reviewable, with a human in the loop as a compliance principle under the EU AI Act, GDPR-compliant and hosted in the EU. Automation you can put in front of an auditor.
In clinical research, data privacy is non-negotiable. Climedo’s AI runs inside our own EU server environment, so your study data stays where your trial does, never in a public AI service. Your data is never used to train public AI models.
Documents, voice notes and verbatims are processed inside our secure environment and deleted from our servers within seconds.
Advanced language models run inside our private, EU-hosted architecture in Frankfurt, with no processing outside the EU: the power of modern AI without the risk of external exposure.
At Climedo, data security comes first. Our hosting partner, from whom we lease servers, is ISO 27001 certified (Standards for Information Security Assurance). In addition, we rely on strong data separation and state-of-the-art encryption methods. At the federal level, our system has also been tested by the BSI and the BfDI.
Prof. Dr. Christoph Schmitz
Chief Medical Officer, Auto Tissue Berlin
Case Study
