Collect, validate, and share study data from any source, eCRF, ePRO, eConsent, or direct from the clinical record. Climedo’s EDC is the foundation for next-generation, AI-assisted data capture with near-zero manual entry.
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, Phone-Pairing 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.
EDC enables electronic data capture as part of your clinical trials and surveys. It can be used both before and after the market approval of your products, and supports you in continuously proving their performance and safety.
Climedo's EDC system offers you various modules that you can flexibly combine as you wish: eCRF, eCOA and ePRO, eSurveys and soon also eConsent and Televisit.
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.
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 (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.
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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.
We'll show you how to start a clinical trial or survey and address your specific needs and desires.
All study participants are connected in a secure, holistic system. Simple assignment of roles and rights for different users.
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.
Thanks to automated processes, administrative tasks are eliminated. This goes hand in hand with a significant reduction of time and costs.
Cloud-based remote monitoring of patients and study processes significantly reduces the effort for CROs and sponsors.
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.
The Climedo system is audited according to relevant standards and guidelines such as ICH GCP, GAMP5, FDA 21 CFR Part 11 and EU GMP Annex 11.
At Climedo, data security comes first. Our hosting partner, from whom we lease servers, is 27001 certified (ISO 27001 – 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.
Thanks to the simple handling (independent of location or device), the intuitive usage and the automated reminders, you'll see higher participation and completion rates.
Direct patient feedback and paperless data collection will improve your data quality. With Climedo, the error-prone transfer of paper to Excel sheets and illegible handwriting become a thing of the past.
Faster results thanks to automated processes, reusable forms and decentralized study designs as well as remote monitoring.
Prof. Dr. Christoph Schmitz
Chief Medical Officer, Auto Tissue Berlin
