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Automate Regulatory-Grade RWE with Self-Driving Studies

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

See the RWE Platform in Action
80%
Cost Reduction2
70%
Faster Study Completion3
100%
Consented Patients4
Catalyst Platform

Generating Submission-Ready Real-World Evidence is Slow and Expensive

The demand for RWE is accelerating1, but traditional methods can't keep up. The current landscape forces unacceptable compromises between cost, quality, and compliance.

The Site Burden

Traditional site-based models create unsustainable burden. Studies spend 60-70% of budgets on data management2, with an average 6.57% error rate3.

The Data Aggregator Gap

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.

The Point Solution Challenge

Integrating specialized vendors (Data, EDC/CDMS, ePRO/eCOA) creates complex ecosystems, data reconciliation issues, and critical compliance risks (21 CFR Part 11)5.

The Future of RWE: The Self-Driving Study Platform

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 Catalyst Architecture

Layer 1

Compliant Infrastructure

The GxP and 21 CFR Part 11 compliant eClinical Suite

EDC/CDMS ePRO/eCOA eConsent APIs
Layer 2

Data Connectivity

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.

DTP EMR (FHIR+HIPAA) Complete Medical Claims Full Pharmacy Claims Labs
Layer 3

AI Orchestration

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

Data Extraction CDISC Mapping I/E Screening (Coming Soon) ePRO/eCOA Triggering
Layer 4

Expert Services & Human Oversight

Full-service approach with comprehensive support and quality assurance by medically trained clinical staff8

Recruitment IRB Submission Data Management Clinical Data Review

Catalyst End-to-End Workflow

See how Castor automates the journey from recruitment to submission-ready data, while ensuring quality through rigorous human validation and risk-based quality management9.

1

Multi-Channel Recruitment & eConsent

2

EMR and Claims Data Retrieval

Automated 3

AI Processing & Screening

Human Oversight 4

Clinical Data Review and Push to EDC/CDMS

Automated 5

Data Delivery via EDC/CDMS and API

🎯 Automated I/E Screening - Coming Soon!

Be the first to access our automated inclusion/exclusion screening capabilities. Join our early access program.

Purpose-Built for High-Impact Evidence Generation

Prospective Registries & Natural History

Long-term disease tracking with automated EMR refreshes and ePRO/eCOA collection

External Control Arms (ECAs)

Precisely matched historical controls for single-arm trials

Post-Marketing Safety (PASS/PMR)

FDA-compliant safety surveillance and reporting

Screen-to-Enroll Workflows

Build screening cohorts by pulling medical records for screening purposes, creating higher quality pre-screened patients for clinical trials

A Fully Consented Patient on a 21 CFR Part 11 Compliant Clinical Trial Platform

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
DATA ACCESS
D2P EMR Access (Clinical Data) Yes Yes ? No
Integrated Claims & Pharmacy Data Yes No Yes No
No Tokenization Costs Yes ➖ No ➖
AUTOMATION
AI-Powered Data Extraction Yes Yes No No
Automated Mapping to CDISC Domains Yes No No No
INFRASTRUCTURE
Integrated EDC/CDMS (21 CFR P11) Yes No No No
Integrated ePRO/eCOA/eConsent Yes No No No
COMPLIANCE
100% Consented Patient Compliance Yes ? ? No
Full Patient-Level Audit Trail Yes Yes No Yes
Clinical Oversight by Medically Trained Staff Yes No No No

Expertise Across All Therapeutic Areas

Oncology

Cancer registries and real-world treatment patterns. Automated chart abstraction for progression, response rates, and survival outcomes.

See: RenovoRx RR5 Registry →

Central Nervous System

Natural history studies for neurodegenerative diseases. Longitudinal cognitive assessments and disease progression tracking.

Rare Disease

Patient registries for ultra-rare conditions. Direct-to-patient enrollment and natural history data collection across global populations.

See: TFE3 Registry →

Respiratory & Allergy

Real-world effectiveness studies for asthma and COPD. Automated extraction of exacerbations, hospitalizations, and treatment patterns.

Infectious Disease

Vaccine effectiveness and outbreak surveillance registries. Rapid deployment for real-world safety monitoring.

Cardiovascular

GLP-1 registries and metabolic endpoint collection. Automated data retrieval for cardiovascular and diabetes outcomes assessment.

See: BEACON Study →

Real-World Success Stories

See how leading organizations accelerate RWE generation with Castor Catalyst

The Omnia BEACON Study: The Self-Driving Trial™

GLP-1 Agonists for Obesity Management

The BEACON Study, sponsored by Omnia Health Solutions, is a landmark decentralized study utilizing zero-touch data pipeline. Using FHIR-based API integration, Catalyst directly retrieves structured EHR data from participating health systems. Data is processed by proprietary AI engine, mapped to EDC system, and used to automatically trigger PRO surveys. Generates regulatory-grade real-world evidence by eliminating manual data entry and monitoring bottlenecks.

The RenovoRx RR5 Registry: Hybrid Model for Post-Marketing Surveillance

RenovoCath® Catheter Clinical Registry

The RenovoRx RR5 Clinical Registry illustrates a hybrid study model blending centralized data automation with site-level involvement. Castor acts as centralized virtual site, using HIPAA release to retrieve baseline and long-term follow-up data directly from patient EMRs, including complex data points such as tumor response and survival status. Clinical sites responsible only for procedural and imaging data, creating scalable solution for post-marketing surveillance.

The TFE3 Registry: Powering Ultra-Rare Disease Research

Ultra-Rare Neurodevelopmental Disorders

The TFE3 Registry is a parent-led initiative focused on ultra-rare neurodevelopmental disorders. Demonstrates Catalyst's capability to manage highly complex, longitudinal data for challenging therapeutic areas. Uses HIPAA release to collect and harmonize years of unstructured medical records from numerous healthcare providers, including clinical notes, lab results, and imaging reports. Public-facing recruitment form enables global enrollment, creating robust regulatory-grade datasets from disparate real-world sources.

Case Study 1 of 3
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Click on the highlights to compare Castor against legacy vendors

Why 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 Deployment

4-8 weeks to go live with pre-validated workflows and automated setup

✗ Traditional: Slow Setup

12-16 weeks of manual configuration and vendor coordination

✓ Castor: Self-Driving Automation

AI-powered chart review with 0% error rate and human validation

✗ Traditional: Manual Processes

Error-prone manual abstraction with 15-20% typical error rates

✓ Castor: Full Compliance

21 CFR Part 11, HIPAA, GxP compliant with complete audit trails

✗ Traditional: Compliance Gaps

Fragmented systems with incomplete audit trails

Frequently Asked Questions

What exactly is a "Self-Driving Study"?

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).

How does Castor ensure 21 CFR Part 11 compliance?

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.

How do you guarantee a 0% error rate?

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.

How is Castor different from data vendors?

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.

How do you access Medical and Pharmacy Claims data? Do you use tokenization?

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.

How does Castor ensure the data is regulatory-grade and FDA compliant?

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).

How We Calculate Our Performance Claims

Transparent methodology behind our platform metrics

80% Cost Reduction2

Calculated by comparing traditional site-based chart review costs vs. our direct-to-patient automated extraction model.

  • Eliminates site startup fees ($15K-25K per site)
  • Reduces manual transcription time by 90%
  • Single IRB vs. multiple site IRBs
  • Based on analysis of 12 comparative studies

70% Faster Study Completion3

Time from protocol finalization to database lock comparing traditional vs. Catalyst approach.

  • Traditional chart review: 32-40 weeks average
  • Catalyst automated approach: 12-18 weeks average
  • Based on retrospective analysis of 25+ studies
  • Includes patient recruitment through data lock
  • Site-CRA communication processes maintained before database lock

100% Consented Patients4

All patients in Catalyst studies provide explicit digital consent with full audit trails.

  • HIPAA-compliant digital consent process
  • Patient-mediated data access permissions
  • Full audit trail for regulatory submissions
  • 21 CFR Part 11 compliant consent workflows

Regulatory Compliance & FDA Guidance

Castor Catalyst is built to meet and exceed all FDA requirements for RWE generation

21 CFR Part 11 Compliance1

Full compliance with electronic records and electronic signatures requirements. Automated audit trails, user authentication, and data integrity controls.

View FDA Guidance →

RWD/RWE Framework2

Aligned with FDA's Real-World Evidence Program framework for using RWD to support regulatory decisions.

FDA RWE Program →

Data Standards for Drug & Biological Product Submissions3

Support for CDISC standards (SDTM, ADaM, ODM) and FDA data submission requirements.

Data Standards Resources →

Use of Electronic Health Records in Clinical Investigations4

Compliant with FDA guidance on using EHR data as source documentation in clinical investigations.

EHR Guidance →

Electronic Source Data in Clinical Investigations5

Direct data capture from electronic sources with maintained data integrity and attributability.

eSource Guidance →

Data Integrity and Compliance with CGMP7

Adherence to ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available.

Data Integrity Guidance →

Reference Citations

  1. FDA. Use of Electronic Health Record Data in Clinical Investigations. July 2018.
  2. Castor Internal Analysis. Cost Comparison: Traditional Site-Based vs. Direct-to-Patient Chart Review. Based on 12 comparative studies, 2023-2024.
  3. Castor Performance Metrics. Study Timeline Analysis: Traditional vs. Catalyst Automated Approach. Based on retrospective analysis of 25+ studies, 2022-2024.
  4. Castor Compliance Report. Digital Consent and Patient Authorization Rates. 100% consent compliance across all Catalyst studies, 2023-2024.
  5. FDA. 21 CFR Part 11, Electronic Records; Electronic Signatures. Updated 2023.
  6. FDA. Electronic Source Data in Clinical Investigations. September 2013.
  7. FDA. Data Integrity and Compliance With Drug CGMP. December 2018.
  8. Clinical Trials Transformation Initiative. Quality by Design Principles in Clinical Trials. 2024.
  9. TransCelerate BioPharma. Risk-Based Quality Management Methodology. 2023.

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