For pharma, CROs & research centres
AI ECG analysis for clinical trials, cardiac safety and research at scale.
Cardiolyse gives sponsors, CROs and academic research groups a certified, device-neutral ECG AI engine — for centralised ECG reading, cardiac safety monitoring, QT prolongation surveillance and digital-biomarker discovery. Standardised, auditable, and fast enough to keep pace with modern decentralised trial designs.
Use cases
Purpose-built for sponsors, CROs and research groups.
Whether you're screening participants, tracking cardiac safety through Phase I to IV, or mining historical ECG datasets for digital biomarkers, Cardiolyse plugs into your existing trial infrastructure — no proprietary hardware, no lock-in.
Centralised ECG reading
Consistent, core-lab-quality reads across every site and every visit. Cardiolyse standardises ECG interpretation so inter-reader variability stops being a source of trial noise.
Cardiac safety & QT monitoring
Automated QT/QTc measurement, arrhythmia detection and cardiotoxicity surveillance — for oncology, CNS and cardiovascular studies where drug-induced cardiac risk has to be watched closely.
Digital biomarker discovery
Extract up to 300 vital ECG parameters and HRV metrics across your dataset. Ideal for building disease-risk scores, patient-stratification biomarkers and treatment-response endpoints.
Fits every study design
Site-based, hybrid and fully decentralised trials — one interpretation engine.
Modern trials mix on-site 12-lead ECGs with home-based wearable recordings. Cardiolyse ingests all of them, harmonises the reads and delivers one auditable dataset back to your sponsor, CRO and statistical team.
Central ECG core-lab reads
Replace or augment traditional core-lab overreads with AI-assisted interpretation. Turnaround measured in minutes, not weeks, with full cardiologist sign-off available where the protocol requires it.
- 12-lead resting ECG or Holter recordings
- Automated QT/QTc, arrhythmia and ischaemia analysis
- Structured JSON export for statistical analysis (SAS/R)
- Full audit trail per recording and per protocol version
- ECG Workspace available to support the cardiologist’s work
Wearable & remote ECG capture
Enable at-home participation with any 1- to 12-lead wearable, patch or consumer ECG device. Cardiolyse harmonises the reads with in-clinic 12-lead data, so your endpoints stay comparable across visit types.
- Any-device ingestion — wearables, patches, home ECG
- Automatic signal-quality scoring per recording
- Personal Baseline Score to detect participant drift
- Standardised outputs across site and home visits
- Fits Phase I healthy-volunteer through Phase IV real-world
Why sponsors and CROs pick Cardiolyse
Faster turnarounds, cleaner endpoints, defensible cardiac safety.
Standardise reads across sites. One AI does the first read at every site, in every country, on every device — so inter-reader variability stops corrupting your endpoint.
Cut ECG turnaround from weeks to minutes. Sponsors and DSMBs get interpretations fast enough to make real-time safety decisions between visits.
Documented, auditable cardiac safety. Every measurement is versioned, timestamped and traceable to the algorithm build that produced it — critical for regulatory submissions.
Device-neutral, protocol-neutral. Whatever ECG devices your sites already use, and whatever visit schedule your protocol demands, we work with what you have.
Digital-endpoint ready. Structured outputs suitable for regulatory-grade primary and secondary endpoints, plus digital biomarker exploration under a research licence.
EU-hosted, GDPR-compliant. Data stays in the EU under ISO 27001-aligned controls, with signed DPAs and a Class IIa CE-certified analysis engine. Cardiolyse is also certified by NHS Digital for Data Security and Protection compliance.
How Cardiolyse fits your trial
From participant screening to final data lock.
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01
Screen
Accelerate participant enrolment with rapid, standardised ECG-based screening — QT prolongation, arrhythmia burden and eligibility flags in minutes.
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02
Monitor
Continuous or scheduled ECG capture across visits, with AI first-read and cardiologist adjudication where the protocol requires it.
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03
Analyse
Up to 300 vital ECG parameters, HRV metrics and Personal Baseline Scores per participant — exported to your biostats stack.
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04
Report
Deliver clean, auditable, regulator-ready cardiac-safety and endpoint data at every DSMB and at final lock.
Research track record
Real deployments across hospital pilots, rural cardiology and EU research programmes.
Cardiolyse has been used in real programmes — from EU-funded rural care procurement to hospital telemonitoring pilots — with named academic and clinical partners.
CRANE: pre-commercial procurement for remote chronic care
Cardiolyse took part in CRANE, an EU H2020 procurement programme for chronic patients in Sweden, Spain and Norway, contributing ECG analysis plus HRV analytics.
Cardiolyse improves cardiovascular care at Oxford University Hospitals
Taken through TheHill Oxford’s formal pipeline process to pilot stage at the John Radcliffe Hospital, working with one of the leading cardiologists at Oxford University Hospitals.
Post-ablation telemonitoring with GVM Care & Research at Maria Cecilia Hospital
A 12-week remote cardiac monitoring pilot with the arrhythmology team at Maria Cecilia Hospital, Italy, using a Beurer handheld ECG device and the Cardiolyse platform.
Research partners
Working with leading European research centres and industry partners.
Frequently asked
Questions sponsors, CROs and PIs ask us before running a study.
Can Cardiolyse serve as a central ECG core lab for our trial?
Yes. Cardiolyse can act as the centralised ECG interpretation layer across all sites — with AI first-reads, cardiologist adjudication for regulated endpoints, full audit trails and structured data exports for your biostats team. We can operate as a standalone core lab or in partnership with your existing CRO.
How is QT / QTc measured for cardiac safety monitoring?
The algorithm performs automated QT and QTc measurement (Bazett and Fridericia corrections) on 1- to 12-lead recordings, with quality-of-signal scoring and per-lead measurements. Alerts can be configured for protocol-defined QTc thresholds, and cardiologist adjudication is available where the study requires it.
Which trial phases and study designs does Cardiolyse support?
Phase I healthy-volunteer through Phase IV real-world. Site-based, hybrid and fully decentralised designs. Any lead count from 1 to 12, any recording duration from a 10-second resting ECG to a multi-day Holter or continuous patch.
How do you handle regulator-grade endpoints?
The analysis engine is CE-marked Class IIa medical device software under EU Regulations, operating under an ISO 13485 QMS. For regulated primary endpoints we recommend a hybrid workflow — AI first-read plus cardiologist adjudication — which we can deliver through the Cardiolyse network of reading cardiologists.
What ECG data formats and devices can we send you?
Any 1- to 12-lead digital ECG. Supported formats include XML, SCP-ECG, DICOM-ECG, PDF and common proprietary vendor exports. Wearables, patches, Holters and 12-lead diagnostic ECG carts are all supported — the analysis output is harmonised so cross-device comparison stays clean.
How is participant data protected under GDPR?
All processing happens in EU data centres, encrypted in transit and at rest, under a signed Data Processing Agreement. Cardiolyse is ISO 27001-aligned, GDPR-compliant and certified by NHS Digital for Data Security and Protection compliance, and can operate on pseudonymised or fully anonymised datasets.
Can we access Cardiolyse for retrospective ECG dataset analysis?
Yes. Retrospective ECG datasets — for biomarker discovery, algorithm benchmarking or observational research — can be processed under a research licence. We provide the structured measurement export required for downstream statistical modelling.
For everything else, see the full FAQ.
Talk to us about your cardiac-safety or research programme.
Whether you need a central ECG reading service, a cardiotoxicity monitoring layer or a digital-biomarker exploration partner, our team will scope the fastest path from your protocol to clean data.