Home Solutions EDC

Fast Setup, High Usability, Developed With Clinicians

Low-effort, AI-supported intelligent solution for fast, modular study setups with intelligent data imports. Setup in days, not weeks. Designed for patient-centric Real-World & Late-Phase Research.

Pricing & Packages

Why Study Teams Choose Climedo EDC

01

Deploy Studies in Days

Climedo is developed with clinicians and is very intuitive in design. No coding skills needed: you are ready to set up your study in days, after only 2 hours of training.

  • Prompt forms or use drag-and-drop elements, no code needed
  • Use Climedo’s rich knowledge base: watch videos and ask questions to get up to speed, without paying for additional support
  • Affordable, with our best value-for-money promise
02

Real-Time Dashboards

Monitor study progress, quality and performance in real time, to make real-time decisions and monitor the overall study remotely.

  • Remote monitoring with Source Data Verification (SDV) ensures regulatory readiness and saves significant time and money
  • Configurable widgets per study: data capture progress, query status, site comparison and clinical values
  • Benchmarking and progression views let sites compare their patients with the whole study
03

Unified Platform

Integrated data capture, based on your requirements and needs, combined in one holistic solution.

  • Study data from EHR, eCRF, eCOA, laboratory, wearables and other devices in one central environment
  • Combine eCRF, eCOA/ePRO and eSurveys as modules, with one login and one audit trail
  • Interfaces to EHR and hospital systems bring source data in without re-typing

What does EDC mean?

The Climedo EDC is the single source of truth for your study: a holistic overview of the whole study and direct interaction with the patients involved. One login. One system. All data in one place.

Climedo's EDC system offers you various modules that you can flexibly combine as you wish: eCRF, eCOA and ePRO, eSurveys, eConsent and televisits.

Climedo Ecosystem

EDC Built for Real-World Studies, Ready for Autonomous Data Capture (ADC)

Source data from EHR, voice and images flows straight into your study, with near-zero manual entry. The AI Study Configurator sets studies up in days, Photo Capture brings documents in, and AI Medical Coding structures the results, each with a human in the loop.

Everything below is the proven EDC foundation. Autonomous Data Capture is what sits on top: the difference between typing data in and letting it flow from the source.

See How ADC Works

AI Study Configurator

From Protocol to Live Study

The AI reads your protocol, shows how the study maps to Climedo, turns it into study specifications and generates the study: forms, visits, randomization, ePRO, edit checks, queries and SAE forms. Protocol changes come back as reviewed amendments, the AI checks the setup against your requirements before UAT, and your team approves every step. Setup effort drops from days to hours.

Discover the AI Study Configurator Arrow Right

EHR-to-EDC

Photo Capture: Your Patients’ Health Data in 3 Clicks

Take live photos or capture screenshots from your HIS/PIS or any other document on your phone and stream them straight into Climedo. AI extracts the eCRF fields from your uploaded images and pre-fills the forms with medical history data, and the site reviews and saves each value.

  • Source files deleted within seconds
  • AI runs in Climedo's EU cloud
  • Never used to train AI 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

AI-Powered Medical Coding, With Human-in-the-Loop

The moment a site submits a free-text CRF field, the verbatim is automatically queued for coding, no manual export or import required. Medical coders always have full context, patient ID, SAE reference, form name, even table row, one click away. Each suggestion carries a confidence score, high, medium or low. Study-specific prompts and past approvals continuously refine accuracy.

Smart Split

Compound verbatims are automatically split into individual terms, each independently coded, reviewed and linked as siblings. Privacy by design: verbatims are anonymised before AI processing, the AI runs in Climedo's EU cloud and your data is never used to train any external AI models.

eCRF – Electronic Case Report Forms

Set up electronic CRFs in our holistic EDC system in a quick, easy and modular way to collect examination data from patients and view them in real time. Plausibility checks and dependencies in the input fields improve user-friendliness and data quality.

Modular study elements can be saved as templates and displayed in our platform in no time at all – without the need for any programming skills.

eSurveys – Digital Surveys

Climedo's eSurvey solution can be used for the quick and easy creation of medical device and pharmaceutical surveys as well as patient recruitment. All questions can be flexibly adapted by you.

Participants can conveniently answer questionnaires at any time and from any location on the device of their choice (smartphone, tablet, computer). Our eSurvey tool can be used as a standalone solution with QR code registration as well as in combination with eCRF and eCOA/ePRO.

eCOA & ePRO

eCOA (Electronic Clinical Outcome Assessment) and ePRO (Electronic Patient-Reported Outcome) are a component of our EDC system. Electronically record any data about the study participants of your clinical trial.

Automated notifications ensure that patient diaries are completed fully and on time. This gives you more high-quality data and ensures higher patient compliance.

Learn more.

(S)AE Reporting

Capture and report serious adverse events without leaving your study.

Structured (S)AE forms, automated notifications to the right stakeholders, and a complete audit trail keep safety reporting compliant and traceable. Every event is captured, reviewed, and documented alongside the rest of your study data, ready for inspection.

HCP Engagement & Cross-Site Comparison

For HCPs, comparing their own patient cohort with cohorts from other sites is a strong motivator, and it encourages best-in-class results for every patient. With early data analysis and evaluations within a specific patient pool, HCPs can adjust their therapeutic decisions to patients' benefit long before final results are published.

A Drive for Excellence

Cross-site comparison fosters healthy competition and a drive for better patient outcomes. The insights it surfaces deepen HCPs' involvement and dedication to the study's success.

“One special feature of this study is Climedo’s dashboard and benchmarking tool […]. This allows participating physicians to monitor changes in their patients’ [conditions] in real time during the trial and compare them as part of a benchmarking approach.”

Prof. Dr. Oliver Weingärtner, Prof. Dr. Volker SchettlerDGK press release, Sept. 2022
Product Demo

We Offer Different Packages and Prices - Tailored to You and Your Needs.

We'll show you how to start a clinical trial or survey and address your specific needs and desires.

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Your Benefits With Climedo

HOLISTIC SOLUTION

All study participants are connected in a secure, holistic system. Simple assignment of roles and rights for different users.

BETTER DATA

No more manual data transfer from paper to Excel. Narrower default options for eSurveys, such as multiple-choice questions, reduce the chances of incorrect data.

TIME & COST SAVINGS

Thanks to automated processes, administrative tasks are eliminated. This goes hand in hand with a significant reduction of time and costs.

REMOTE MONITORING

Cloud-based remote monitoring of patients and study processes significantly reduces the effort for CROs and sponsors.

REAL-TIME DATA OVERVIEW

Thanks to a clear overview in our dashboards, you can keep an eye on your study at all times. Interfaces to external data sources, such as EHRs, make data collection even easier.

AUDITED AND VALIDATED

The Climedo system is validated and audited against the relevant EU and US standards and guidelines, such as ICH GCP, GAMP 5, FDA 21 CFR Part 11 and EU GMP Annex 11, and is HIPAA compliant.

Proven audit experience

No sponsor, CRO or other customer has ever stopped or cancelled an engagement with Climedo due to an audit.

Secure data hosting

Data stored on ISO-certified servers in Frankfurt, with off-site backups, redundant servers and SSL-encrypted data transfer. For EU studies, no data is processed outside the EU; US hosting is possible on request.

All relevant EU/US norms fulfilled

Compliance with:

  • 21 CFR Part 11 (FDA)
  • ISO 9001:2015 (QMS)1
  • EU GMP Annex 11 and EU Regulation 536/2014
  • GAMP 5 V-Model (software validation)
  • ICH Good Clinical Practice (GCP)
  • Declaration of Helsinki, German national regulations and GDPR
  • HIPAA (US health data privacy)

1 Compliant, not certified2 The tester has full knowledge of the system being tested3 Conducted in 2020–22 for the COVID-19 symptom diary and contact tracing project

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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Patient Adherence

Digital Health Bites

Go to our Blog Arrow Right Mini

Tereza | Senior Customer Success Manager

The Rise of Digital Therapeutics: Transforming Healthcare in the Digital Age

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The Rise of Digital Therapeutics: Transforming Healthcare in the Digital Age

"The perfect combination of simplicity and elegance convinced me. In addition, Climedo's pricing model is very attractive for our task and study size."

Prof. Dr. Christoph Schmitz

Chief Medical Officer, Auto Tissue Berlin

Product Demo
We offer different packages and prices - tailored to you and your needs.
Get Demo Contact Us