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The Real-World Evidence Platform for Pharma Sponsors and CROs

Climedo brings launch and post-approval studies, from non-interventional and registry studies to direct-to-patient studies and surveys, onto one EU-hosted eCOA and EDC platform. 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. Efficacy and safety evidence is visible while the study is still running.

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Why Real-World Evidence Is Hard to Collect

In most real-world and late-phase studies, data still reaches the eCRF by hand: typed in from paper, PDFs, EHRs or other clinical documents. That manual step is where time, data quality and speed to insight are lost, inside post-approval windows that are short to begin with.

Every Real-World Study Type on One Platform

Surveys and Direct Feedback

Patient satisfaction and quality-of-life surveys, HCP feedback and market research, on any device, in several languages.

Direct-to-Patient Studies

eCOA and ePRO, eConsent and decentralized designs, with automated reminders and no app to install.

Non-Interventional Studies (NIS)

Post-approval, observational, implementation and registry studies with full EDC, source data verification and site management.

See all study types

Built for Pharma Sponsors and CROs

For Pharma and Biotech Sponsors

  • Phase I, launch and post-approval studies (Phase IV), interventional or non-interventional.
  • Real-time insight for medical affairs and MSLs, for scientific exchange with HCPs while the study runs.
  • All servers in Frankfurt, GDPR-first: critical for EU pharma.
  • Studies launch in 3 to 5 days instead of 2 to 3 weeks.

For CROs

  • One platform across your sponsors and studies.
  • Reusable form templates and workflows instead of building every study from scratch.
  • Granular roles and rights for sponsors, sites and monitors.
  • Data exports in common formats for sponsor deliverables.
  • Teams onboarded in hours, without programming skills.

From Source Data to Evidence, Without Re-Typing

Autonomous Data Capture moves study data into the EDC in three stages, with a human in the loop.

  1. Stage 1

    Source Capture

    Source data comes in without manual entry.

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

    AI Extraction

    AI structures unstructured data.

    • 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
    • Query management

How Autonomous Data Capture works

Evidence While the Study Runs

Real-Time Dashboards

Follow recruitment, compliance and selected parameters across visits, benchmark sites and spot outliers early. Descriptive while the study runs, never a prescribing aid.

Dashboards and insights

Launch in Days

The AI Study Configurator turns your protocol into a ready study, from eCRFs, visits, randomization and ePRO to edit checks and SAE forms, so a study goes from protocol upload to live in 3 to 5 days instead of 2 to 3 weeks.

Study start-up in 3–5 days

Built for Regulated Research

Compliance · Case study: Phase IV study with ePRO

Frequently Asked Questions

What is real-world evidence?

Real-world evidence (RWE) is clinical evidence about the use, benefits and risks of a treatment, drawn from real-world data such as health records, patient-reported outcomes and registries, rather than only from randomized controlled trials.

Which study types does Climedo support for RWE?

Patient surveys, direct-to-patient studies with eCOA and ePRO, and non-interventional studies such as post-approval, observational, implementation and registry studies.

How does data from hospital records get into the study?

Through EHR integration where it exists, and otherwise through photo capture: sites photograph or screenshot a record, AI extracts the eCRF fields and the site reviews them before saving.

Where is the data hosted?

All servers are in Frankfurt (AWS region); for EU studies, no data is processed outside the EU, and US hosting (HIPAA) is possible on request. AI processing runs in private, EU-hosted model instances, and your data is never used to train public AI models.

Which study phases does Climedo support?

Phase I to IV, interventional and non-interventional, with a focus on Phase I, launch and post-approval studies.

Can a CRO run studies for several sponsors on Climedo?

Yes. CROs run their studies on one platform, with reusable templates and workflows, granular roles and rights, and data exports in common formats.

See How Climedo Runs Real-World Evidence for Sponsors and CROs

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