Cardiolyse gives sponsors and CROs a device-neutral, CE Class IIa ECG analytics engine for patient identification, risk stratification, treatment-response tracking and cardiac safety read-outs — delivered as a controlled study service with traceable outputs.
New medicines still reach approval with QTc warnings. Cardiovascular disease is under-represented in clinical research, yet it is still the leading cause of death in Europe. Consistent, centrally analysed ECG data helps studies characterise cardiac effects and report them with confidence.
The same analysis engine can serve different questions across a programme. Each use is scoped with you, so the outputs match the protocol and the evidence that supports them.
If you have not chosen an ECG device yet, Cardiolyse can offer a joint solution: a wearable from our device partners, matched to your protocol, plus the analytics behind it — one set-up instead of two separate suppliers.
Most programmes begin with a bounded, fixed-scope project on data you already hold. It proves the fit before anything is built into a live protocol.
A retrospective analysis of your existing ECG dataset against a specific development question, with a written report and a QC package.
Protocol-defined ECG analysis for an ongoing or planned study, with the algorithm and configuration locked for the study.
Joint work on ECG-derived biomarkers for a disease area, from exploration on retrospective data to prospective validation.
We see it as one of the richest signals a trial collects. With consistent, automated analytics, the same recordings that confirm safety can also reveal how a therapy affects the heart.
Every output can be traced back to the recording, the configuration and the algorithm version that produced it.
We agree the question, the ECG data, the outputs and who reviews what — before any processing starts.
The algorithm version and study configuration are fixed and documented for the whole study.
Recordings are quality-checked, analysed and logged. Defined outputs go to independent review where the protocol needs it.
You receive structured exports, reports and the QC and audit package for your statistical analysis.
No. Cardiolyse supplies the ECG analytics, the consistency and the traceability. Your CRO or core lab keeps adjudication, trial-data operations, medical oversight and regulatory submission responsibilities.
Yes. A retrospective feasibility study on an existing, lawfully held ECG dataset is the usual first step. It answers one defined question before any prospective work.
Native digital ECG files are preferred: 12-lead resting ECG, 1- to 3-lead Holter and wearable or patch recordings. Each study defines its supported inputs, and anything outside them is rejected and logged.
Yes. Cardiolyse can offer a joint solution: a wearable from our device partners, such as Beurer, Corsano or Movesense, matched to your study needs, together with the analytics — coordinated as one set-up.
The algorithm version and configuration are locked for the study and documented. Every result is traceable to the source recording and the settings used.
Validation depends on the score and the population. The Risk of Heart Disorders score has independent evidence in heart failure. For other uses, we agree a fit-for-purpose validation plan as part of the study.
Processing runs in the EU with GDPR & HIPAA-aligned data handling and ISO 27001-aligned security, under the data processing terms agreed for the study.
Tell us about the study and the data. We will propose a scoped first step.
