Autonomous Data Capture. Study Data, Straight From the Source.

Most clinical data still reaches the database because someone typed it in. Autonomous Data Capture (ADC) breaks that bottleneck: study data flows from documents, patients and HCPs with near-zero manual entry, so efficacy and safety insights reach HCPs and KOLs in real time, while the study is still running.

The Manual Bottleneck

In most real-world and late-phase studies, data still travels from patient to database by hand, transcribed from paper, PDFs, portals and clinical records. That manual step is where time, quality and speed-to-insight are lost.

Autonomous Data Capture Removes It

Instead of re-keying, Climedo captures study data at the source and turns it into structured, validated evidence, with a human in the loop, not a data-entry team. Documents, patient input and HCP input all flow into one engine, and out as real-time insight.

How Autonomous Data Capture Works

Source data flows into your EDC in three stages, with no manual transcription.

  1. Stage 1

    Source Capture

    Data originates without manual entry.

    • EHR and HIS integration
    • PDF upload and scan
    • Voice entry
    • Photo capture via smartphone
  2. Stage 2

    AI Extraction

    AI structures the unstructured.

    • Data mapping
    • Confidence score
    • 4 eye principle
    • Unit conversion
    • Any-language input
  3. Stage 3

    Filled eCRF

    Human-approved import, with the groundwork done by AI.

    • GCP-compliant
    • Full audit trail
    • 21 CFR Part 11
    • Source verification
    • Query management
Result: near-zero manual data entry. Less site burden, faster study timelines, better data quality.

Where the Data Comes From

Three sources flow into one engine, and out as real-time insight.

LETTER · PDF
RECORD
Demographics

12 fields extracted

Age64
SexF
BMI27.4
Onset03.2024
MED PLAN · JPG
TABLE
Concomitant medications

14 rows prefilled

SUBSTANCEDOSEFREQ
Metformin1000 mgBID Ramipril5 mgQD Atorvastatin20 mgQD
+ 11 rows
QUESTIONNAIRE
PRO
Quality of life

EQ-5D-5L · 5 answers

Mobility 2 Self-care 1 Pain 3 Anxiety 2
VAS 72 / 100
Source documents
Smart Import
Structured study data
SOURCE FILES 3
FIELDS MAPPED 18 36 54
CONFIDENCE ≥ 95%
Unstructured documents in. Analysis-ready data out.

From Documents

PDFs, scans, screenshots and clinical-record exports, read and structured automatically.

From Patients

ePRO, voice, scan and ePA export, captured on any device, no app required.

From HCP Input

Structured forms and smart import, straight from the site, without re-keying.

The Climedo ADC Engine

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.

Real-Time Insights for HCPs & KOLs

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.

Inside the Engine: Three AI Capabilities

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.

Discharge summary CARDIOLOGY · UNIVERSITY HOSPITAL
04.09.2026
SUBJECT004-017 BORN1961 VISIT2 PAGE1 / 4

DIAGNOSIS

Type 2 diabetes mellitus, ICD-10 E11.9

MEDICATION ON DISCHARGE

Metformin1000 mg BID
Ramipril5 mg QD
Atorvastatin20 mg QD

LABORATORY

HbA1c7.2 %
Creatinine0.9 mg/dL
LDL cholesterol128 mg/dL

VITAL SIGNS

Blood pressure138 / 86 mmHg
Heart rate74 bpm
PD DR. MED. A. KELLER
SIGNED
04.09.2026
DXE11.9 · Type 2 diabetes
LABHbA1c 7.2 %
CONMEDMetformin 1000 mg
VITAL138 / 86 mmHg
Smart Import
Source document
AUTOMATED UNIT CONVERSION
LDL128 mg/dL→3.31 mmol/L
Creatinine0.9 mg/dL→79.6 µmol/L
Every value read in place, next to its source.

AI Study Configurator

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.

Discover the AI Study Configurator Arrow Right

Photo Capture

Your patients' health data in three clicks. Photograph or screenshot a lab report, doctor's letter or HIS/PIS record on your phone and stream it straight into Climedo. AI extracts the eCRF fields and pre-fills the form for you to review. Source files are deleted from our servers within seconds of processing, the AI runs in Climedo's EU cloud, and your data is never used to train our models.

01

Pair device

Scan the QR code in the EDC with your phone.

02

Upload documents

PDFs, images or voice notes, straight from your phone.

03

Review and save

AI-extracted data appears in the EDC, ready for review.

AI Medical Coding

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 external models.

Discover AI Medical Coding Arrow Right

Why It Matters for Real-World & Late-Phase Studies

Near-Zero Manual Entry

Cut transcription and the errors that come with it.

Speed to Insight

See efficacy and safety trends while the study is live.

Higher Data Quality

Validated at the source, with a complete audit trail.

Real-Time HCP Dialogue

Share insight with HCPs and KOLs before the last patient visit.

Human-in-the-Loop by Design

ADC is AI-assisted, not AI-alone. 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.

Shielded AI: Security by Design

In clinical research, data privacy is non-negotiable. Climedo’s AI runs inside our own EU cloud perimeter, so your study data stays where your trial does, never in a public AI service.

Closed-Loop Environment

Documents, voice notes and verbatims are processed inside our secure environment and deleted from our servers within seconds. Your data is never used to train public AI models.

Private Model Instances

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.

Data Security

Made in Germany

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.

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