Cardiology

Cardiac safety, QTc evaluation, MACE endpoints, device and imaging integration — all with adjudication traceability.

Cardiology Biometrics & Safety

From arrhythmia monitoring to composite cardiovascular outcomes, we deliver precise analyses and audit-ready documentation.

Safety & Efficacy Endpoints

QTc evaluation per ICH E14; concentration–QT modeling considerations.
MACE composites (CV death, MI, stroke), adjudication charters, and traceable event coding.
Device performance endpoints and imaging-derived measures (echo/MRI/CT) integration.

Data & Monitoring

Holter/ECG pipelines, signal QC, and central reading alignment.
Risk-based monitoring metrics and interim safety analyses for DMCs.
Exposure-adjusted incidence rates and time-to-event analyses.

Modeling & Subgroups

Cox models and recurrent event methods; sensitivity and robustness checks.
Subgroup analyses with multiplicity control and transparent interpretation.
Estimation-focused summaries and benefit–risk framing for governance.

Deliverables

Cardiology SDTM/ADaM structures (e.g., EG, CV events) with define.xml and reviewer guides.
Kaplan–Meier curves, forest plots, shift tables, and device listings.
CSR-ready narratives and responses to authority queries.

Run Smarter Cardiology Studies

Tap Magnus CRO for QTc, MACE, and device analytics with clean traceability from signal to submission.

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