EDC and RWE for Cardiovascular Trials at Any Scale

Cardiovascular research runs the full spectrum from Phase II mechanistic studies to 10,000-patient global outcomes trials. Castor’s unified EDC and RWE platform handles multi-site coordination, registry data ingestion, and parallel RCT and RWE programs without the data entry burden that slows high-volume cardiology sites. Castor Catalyst automates ingestion from hospital systems and registries, reducing data entry costs by up to 80% and scaling from first-in-human to 20,000-patient outcomes programs.

Studies on Platform
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Reduction in Data Entry Costs via Catalyst
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Countries
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Patients in Castor's Largest CV Study
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Why cardiovascular trials demand platform depth

CHALLENGE 01

Scale and multi-site complexity

Large Phase III cardiovascular outcomes trials often involve hundreds of sites across dozens of countries. Managing site coordination, data quality, and protocol consistency at that scale requires infrastructure built for it, not adapted from smaller-trial tools.

Challenge 02

RWE alongside RCT

Cardiovascular research increasingly runs RCT and RWE programs in parallel, sometimes from the same patient cohort. Managing two separate systems creates reconciliation overhead, data quality risks, and regulatory complexity. A unified platform eliminates this.

Challenge 03

Data entry burden at high-volume sites

Cardiology sites generate enormous documentation volume. Manual data entry from hospital systems into EDC creates delays, errors, and staff burnout. Catalyst-automated ingestion from source systems eliminates the manual step.

Challenge 04

Long study durations and endpoint adjudication

Cardiovascular outcomes trials frequently run 5-10 years with complex adjudication requirements. The platform must maintain data integrity, audit trail completeness, and site engagement across a multi-year arc.

Cardiovascular research spans a wider range of study designs than almost any other therapeutic area, from tightly controlled Phase II mechanistic studies to 10,000-patient global outcomes trials running for multiple years. The operational demands at each end of that spectrum are fundamentally different, yet sponsors often need a single platform to handle both.

Built for the full cardiovascular evidence lifecycle

From Phase II mechanistic studies to large-scale outcomes registries, Castor is designed for the scale, automation, and compliance that cardiovascular research demands.

Castor Catalyst: automated data ingestion for CV trials

Castor Catalyst automates data ingestion directly from hospital systems, EHRs, and registry databases into the clinical trial database. Up to 80% reduction in data entry costs. 0% transcription error rate versus 6.6% industry average. Registries can go live in under 2 weeks. The Omnia BEACON study reduced data extraction time from 40 hours to under 4 hours per patient using Catalyst. See how clinical trial solutions built around Catalyst automation change what is operationally possible for high-volume cardiology sites.

Unified EDC and RWE on one platform

Castor unifies EDC for interventional trials and RWE/registry data collection on a single validated platform. No separate system for your registry, no reconciliation between EDC and RWE databases, no additional regulatory burden for running both in parallel. 90%+ patient retention in Castor’s RWE studies. Your cardiovascular real-world evidence program and your Phase III RCT share the same compliance infrastructure from the first protocol version.

Proven at cardiovascular scale: 20,000+ patients, biopharma-grade

Castor’s largest cardiovascular study enrolled 20,930 patients capturing 680,000 data points (blinded sponsor). The Netherlands Heart Valve Survey ran 8,449 participants across 9 centres. 60+ verified biopharma cardiovascular trials have run on Castor. WHO Solidarity demonstrates cross-TA scale proof for multi-country infrastructure reliability. Your Phase III outcomes program needs an electronic data capture system that has already operated at the patient volumes and site counts you are planning for.

Multi-site coordination for large cardiology networks

More than 98% screener completion and 90.5% survey completion in Castor’s cardiovascular RWE and eConsent studies. 1,000+ patients enrolled from 2,500+ screened within 6 months (blinded cardiovascular RWE study). Multi-site dashboards give operational teams real-time visibility across all sites without querying individual site data. These are the operational outcomes that matter for biotech clinical trials managing parallel cardiovascular programs at scale.

Fast activation: most registries live in under 2 weeks

90% of all Castor studies go live in under 4 weeks from contract to first patient in. Cardiovascular registries typically go live in under 2 weeks. No infrastructure to stand up, no per-site software installation, no IT project required. For sponsors running decentralized clinical trials or parallel cardiovascular programs, this activation speed means data starts flowing before legacy platforms have finished scoping the deployment.

Full regulatory stack: from FDA outcomes trials to EU MDR PMCF

FDA 21 CFR Part 11, ICH E6(R2/R3), EU Annex 11, HIPAA, GDPR, EU MDR PMCF. For cardiovascular medical device trials requiring post-market clinical follow-up under EU MDR, Castor handles the data collection infrastructure. Multi-region hosting with national data sovereignty controls. Greater than 99.9% historic mean uptime. 830 million+ data points captured on the platform. For programs that need eCOA solutions alongside EDC under a single validated compliance layer, Castor removes the integration overhead that separate-system approaches create. The regulatory stack is built in, not assembled per-program.

Cardiovascular and large-scale outcomes on Castor

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Verified biopharma cardiovascular trials on Castor, plus large-scale registries and RWE studies. 60+ verified biopharma cardiovascular trials have run on Castor, including large-scale cardiovascular registries and outcomes programs.
Source: Castor verified platform data, 2026

Infectious Disease / Scale Reference

WHO Solidarity Trial (scale proof)

600 sites · 52 countries, infrastructure proof for CV scale
+ Patients

Cross-TA reference demonstrating Castor’s platform reliability at global multi-site scale. For large Phase III cardiovascular outcomes trials, Castor has proven it can manage the data volume, uptime, and regulatory complexity that large-scale programs demand. WHO’s choice of Castor over every enterprise alternative is the most independent validation available in clinical research software.

RWE / Catalyst Automation

Omnia / BEACON Study

Per-patient data extraction time with Catalyst
40 hrs → Under 39 hrs

Omnia used Castor Catalyst to automate data extraction for the BEACON study (Endocrinology cross-TA proof for Catalyst automation). Data extraction per patient dropped from 40 hours to under 4 hours. Cross-TA reference demonstrating Catalyst’s impact on data-heavy trials with high site burden, directly applicable to high-volume cardiovascular RWE and registry programs.

Patients in Castor’s largest cardiovascular study, capturing 680,000 data points.
(Platform data, 2026. Blinded sponsor, referenced as platform data only.)

Rated by clinical researchers on independent review platforms

Frequently asked questions

Yes. Castor has powered cardiovascular studies enrolling 20,000+ patients across hundreds of sites. 90% of all studies go live in under 4 weeks, with dedicated multi-site coordination dashboards providing real-time visibility across the entire study network. Greater than 99.9% historic mean uptime ensures data availability throughout a multi-year outcomes trial.

Castor Catalyst automates data ingestion directly from hospital systems, EHRs, and registry databases into the clinical trial database. This eliminates manual transcription, reducing data entry costs by up to 80% and achieving a 0% transcription error rate compared to the 6.6% industry average. Cardiovascular registries go live in under 2 weeks.

Yes. Castor’s unified platform supports interventional RCTs and observational RWE registries on the same infrastructure. Separate databases, separate access controls, shared platform compliance layer. No reconciliation between EDC and RWE systems, no duplicate regulatory validation requirements.

Castor operates across 160+ countries with multi-region data hosting, national data sovereignty controls, and 80+ language options for site data entry and patient-facing workflows. For studies requiring data to remain within specific jurisdictions (EU, Middle East, APAC), Castor implements regional isolation that prevents cross-border data transfer.

60+ verified biopharma cardiovascular trials have run on Castor, alongside large-scale registries including the Netherlands Heart Valve Survey (8,449 participants, 9 centres) and a cardiovascular outcomes study enrolling 20,930 patients with 680,000 data points captured.

Castor is compliant with FDA 21 CFR Part 11, ICH E6(R2) and E6(R3), EU Annex 11, GDPR, HIPAA, and EU MDR PMCF. For cardiovascular medical device studies requiring post-market clinical follow-up under EU MDR, Castor handles the PMCF data collection infrastructure with full audit trail and regulatory-grade reporting.

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