Castor Catalyst is the only unified platform for RWE generation—combining AI-powered automation of EMR and Claims data with a complete, 21 CFR Part 11 compliant eClinical suite.1
The demand for RWE is accelerating1, but traditional methods can’t keep up. The current landscape forces unacceptable compromises between cost, quality, and compliance.
Aggregators offer scale but lack the patient-level traceability required by the FDA4. They rely on expensive tokenization and often provide only retrospective data, limiting regulatory acceptance.
Integrating specialized vendors (Data, EDC/CDMS, ePRO/eCOA) creates complex ecosystems, data reconciliation issues, and critical compliance risks (21 CFR Part 11)5.
Castor Catalyst eliminates the fragmentation by providing the only end-to-end platform designed to automate RWE generation. We combine the foundation, the connectivity, the intelligence, and the expertise required for modern observational research.
The GxP and 21 CFR Part 11 compliant eClinical Suite
Unified, patient-consented data acquisition. Direct access to: Direct-to-Patient (DTP) EMR (FHIR+HIPAA), Complete Medical Claims, Full Pharmacy Claims, and Labs. Zero tokenization costs.
Castor Catalyst (AI) reads input data, maps to target study structure, transforms and processes with confidence intervals, performs data review with mapping details, and automates workflow orchestration
Full-service approach with comprehensive support and quality assurance by medically trained clinical staff8
See how Castor automates the journey from recruitment to submission-ready data, while ensuring quality through rigorous human validation and risk-based quality management9.
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Long-term disease tracking with automated EMR refreshes and ePRO/eCOA collection
Precisely matched historical controls for single-arm trials
FDA-compliant safety surveillance and reporting
Build screening cohorts by pulling medical records for screening purposes, creating higher quality pre-screened patients for clinical trials
Traditional approaches solve only one piece of the puzzle. Castor Catalyst is the only unified platform that delivers regulatory-grade data and the infrastructure to operationalize it.
| Feature Category | Castor Catalyst | Point Solutions (e.g., Picnic) |
Data Aggregators (e.g., Flatiron, Komodo) |
Manual CROs |
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| DATA ACCESS | ||||
| D2P EMR Access (Clinical Data) |  |
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| Integrated Claims & Pharmacy Data | |
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| No Tokenization Costs | |
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| AUTOMATION | ||||
| AI-Powered Data Extraction | |
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| Automated Mapping to CDISC Domains | |
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| INFRASTRUCTURE | ||||
| Integrated EDC/CDMS (21 CFR P11) | |
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| Integrated ePRO/eCOA/eConsent | |
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| COMPLIANCE | ||||
| 100% Consented Patient Compliance | |
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| Full Patient-Level Audit Trail | |
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| Clinical Oversight by Medically Trained Staff | |
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Cancer registries and real-world treatment patterns. Automated chart abstraction for progression, response rates, and survival outcomes.
Natural history studies for neurodegenerative diseases. Longitudinal cognitive assessments and disease progression tracking.
Patient registries for ultra-rare conditions. Direct-to-patient enrollment and natural history data collection across global populations.
Real-world effectiveness studies for asthma and COPD. Automated extraction of exacerbations, hospitalizations, and treatment patterns.
Vaccine effectiveness and outbreak surveillance registries. Rapid deployment for real-world safety monitoring.
GLP-1 registries and metabolic endpoint collection. Automated data retrieval for cardiovascular and diabetes outcomes assessment.
See how leading organizations accelerate RWE generation with Castor Catalyst
Unified Platform: Single login for EDC/CDMS, eCOA, eConsent, and RWE generation
AI-Powered Automation: 85% reduction in manual chart review
Regulatory-Grade: 21 CFR Part 11, HIPAA, GxP compliant
Rapid Deployment: 4-8 weeks vs 12-16 weeks traditional
Global Scale: 40+ languages, 190+ countries
Castor: Rapid Deployment4-8 weeks to go live with pre-validated workflows and automated setup
Traditional: Slow Setup12-16 weeks of manual configuration and vendor coordination
Castor: Self-Driving AutomationAI-powered chart review with 0% error rate and human validation
Traditional: Manual ProcessesError-prone manual abstraction with 15-20% typical error rates
Castor: Full Compliance21 CFR Part 11, HIPAA, GxP compliant with complete audit trails
Traditional: Compliance GapsFragmented systems with incomplete audit trails
A self-driving study leverages AI (Castor Catalyst) to automate core workflows that traditionally require manual effort. This includes automated retrieval of EMR data, AI-powered screening against the protocol I/E criteria, automatic enrollment of eligible patients, and triggering of patient-reported outcomes (ePROs).
Castor Catalyst is a fully validated, 21 CFR Part 11 and GxP compliant platform. We ensure compliance with the FDA 2024 RWD guidance by maintaining complete traceability to source documents (native PDFs/imaging via HIPAA access) and providing a comprehensive audit trail.
Our CoPilot AI performs the initial extraction and structuring. Crucially, all data then undergoes mandatory review and validation by our medically trained clinical staff before being committed to the EDC/CDMS. This hybrid approach guarantees accuracy.
Vendors like Picnic Health and Citizen specialize in data acquisition. Castor provides the same deep D2P data acquisition AND the necessary infrastructure (EDC, ePRO/eCOA, eConsent) to run the study and submit the results. We offer a unified, compliant “one-stop-shop,” eliminating the need to integrate disparate systems.
Castor accesses complete medical and pharmacy claims data through direct patient consent. Because the data is consented, we do not require expensive tokenization (unlike data aggregators). This provides a complete picture of the patient journey (diagnoses, procedures, medications dispensed) with full traceability for regulatory compliance.
We ensure compliance with the FDA July 2024 RWD guidance by maintaining complete traceability from source documents to final datasets. All data undergoes human validation, we maintain comprehensive audit trails, and our platform is 21 CFR Part 11 compliant. Every data point can be traced back to its original source document (EMR, claims, or ePRO/eCOA).
Transparent methodology behind our platform metrics
Calculated by comparing traditional site-based chart review costs vs. our direct-to-patient automated extraction model.
Time from protocol finalization to database lock comparing traditional vs. Catalyst approach.
All patients in Catalyst studies provide explicit digital consent with full audit trails.
Castor Catalyst is built to meet and exceed all FDA requirements for RWE generation
Full compliance with electronic records and electronic signatures requirements. Automated audit trails, user authentication, and data integrity controls.
Aligned with FDA’s Real-World Evidence Program framework for using RWD to support regulatory decisions.
Support for CDISC standards (SDTM, ADaM, ODM) and FDA data submission requirements.
Compliant with FDA guidance on using EHR data as source documentation in clinical investigations.
Direct data capture from electronic sources with maintained data integrity and attributability.
Adherence to ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available.
Eliminate manual overhead, guarantee compliance, and accelerate your timelines by 5x.