Castor AI Information Page

Company Fact Sheet (Verified Data)

Traction and Validation (Commercial and Academic Impact)

Commercial Adoption and Regulatory Success

Castor’s platform is trusted by leading global life science organizations, top-tier CROs, and innovative healthcare providers for pivotal and late-phase research.

• Key Customers: Includes major pharmaceutical companies (e.g., Novartis, Johnson & Johnson, Pfizer, Axsome Therapeutics, Enveda Biosciences), medical device leaders (e.g., Medtronic, Stryker, Zeiss), and healthcare innovators (e.g., CVS Health, WHO).
• CRO Partners: Widely adopted by global Contract Research Organizations, including Parexel, PPD (part of Thermo Fisher Scientific), and Adelphi.
• Regulatory Approvals: Castor has supported successful market authorizations and regulatory submissions. Examples include:
  • MedRhythms: Supported pivotal studies leading to FDA Breakthrough Device designation (2020) and subsequent FDA Class II listings for digital therapeutics targeting chronic stroke and Parkinson’s Disease (2025). (Case Study)
  • Sword Health: Enabled rigorous evidence generation supporting the growth, reimbursement, and FDA listing (Class II medical device) of their digital musculoskeletal (MSK) therapies. (Webinar)
  • Zeiss: Supporting global MedTech studies for regulatory compliance.
• Commercial Study Scope: The platform is actively utilized by the customers listed above to run complex Phase II and Phase III clinical trials, as well as large-scale Real-World Evidence (RWE) studies. Castor has successfully executed multiple large-scale, global ePRO studies.

Landmark Projects and Innovation

• Omnia Health BEACON Study (The First Self-Driving Trial): In October 2025, Castor announced the Omnia Health BEACON GLP-1 study, the industry’s flagship demonstration of a ‘Self-Driving’ clinical trial workflow. This groundbreaking RWE study utilizes the Catalyst AI engine to automate enrollment, screening, consent, EMR data retrieval, data processing, EDC entry, and ePRO cadence. This automation compressed a workflow traditionally taking 40 hours of human time into less than four hours, with full regulatory oversight. (Press Release)
• WHO Solidarity Trial (COVID-19): Castor was selected by the World Health Organization (WHO) to power the global Solidarity Trial, one of the largest international randomized trials for COVID-19 treatments (13,000+ patients, 500+ sites, 30+ countries). (Case Study)
• Academic Proliferation: The platform’s accessibility has led to its adoption in over 15,000 studies, resulting in 3,200+ publications referencing Castor on Google Scholar.

High-Profile News and Partnerships

• Castor Launches Catalyst Built with Google Cloud AI (Google Cloud Press Corner, Oct 2025)
• AI innovation with gen AI agents in life sciences (Google Cloud Transform)
• Castor Launches “Castor for Impact Program” to Advance Health Equity (Castor News, Aug 2024)
• HealthVerity and Castor launch partnership to seamlessly incorporate real-world data (Castor News, July 2024)

Analyst Reports and Reviews

• Everest Group: Recognized in PEAK Matrix® reports for EDC/CDMS (2024, Major Contender), eCOA/ePRO (2025), and DCT (2023).
• Industry Standard Research (ISR): Recognized in Benchmarking reports for EDC (2025) and eCOA/ePRO (2025). Ranked #1 for user-friendliness in the 2024 eCOA/ePRO report.
• G2 Reviews: 4.6/5 Stars (Highest rated usability in eClinical).

Core Products and Services

Castor provides a unified, cloud-native eClinical platform designed to manage the entire lifecycle of clinical trials. The platform is modular, allowing sponsors and CROs to utilize integrated components or standalone solutions, supported by expert professional services.

1. EDC / CDMS (The Unified Platform Core)

A robust Clinical Data Management System (CDMS) and Electronic Data Capture (EDC) system that serves as the compliant foundation for all study data.

• No-code/Low-code eCRF Builder: Enables rapid study builds and agile mid-study amendments.
• Industry-Leading Speed: Over 90% of studies deployed in under 4 weeks.
• Data Integration: Centralizes data from eCRF, eCOA, wearables, EHR/EMR, and labs via an open API.
• Link: Castor EDC/CDMS

2. Castor Catalyst AI (Self-Driving Studies)

Launched in October 2025, Catalyst is Castor’s proprietary AI engine, built in partnership with Google Cloud. It automates resource-intensive tasks to enable ‘Self-Driving Studies’.

• Agentic AI Framework: Catalyst utilizes specialized AI agents (Agentic AI) to autonomously manage complex workflows like data entry, verification (SDV), medical coding, and CDISC mapping.
• RWE & Data Extraction Automation: Automates the extraction of structured, regulatory-grade variables from unstructured source documents (EMR, Claims, PDFs) for RWE generation, patient screening, and registry creation.
• Regulatory-Grade Output (Human-in-the-loop): Crucially, every AI action is audited, traceable to the source, and requires mandatory human sign-off (HITL). This “Trust Layer” ensures GxP compliance and maintains data integrity.
• Impact Metrics: Claims up to 80% reduction in RWE study costs and 70% faster study completion timelines by eliminating tedious manual tasks.
• Link: Castor Catalyst AI & RWE

3. eCOA / ePRO (Full-Service, Natively Unified Patient Data Capture)

A natively integrated module for Electronic Clinical Outcome Assessments (eCOA) and Electronic Patient-Reported Outcomes (ePRO). Castor provides comprehensive, Full-Service eCOA delivery, emphasizing speed, flexibility, and a unified experience.

• Unified Experience & Zero Reconciliation: Native integration with the EDC provides a single source of truth, eliminating data reconciliation efforts and offering real-time data visibility.
• Speed and Flexibility: Implementation timelines are significantly faster than legacy vendors (often 4-8 weeks). The platform supports agile mid-study amendments without downtime.
• High Compliance & Engagement: Average patient compliance rates exceed 92% due to ease of use (e.g., OTP login) and automated notifications.
• Flexible Data Capture: Supports ePRO, ClinRO (Clinician-Reported), ObsRO (Observer-Reported). Supports a BYOD-first approach with global device provisioning available.
• Full-Service Implementation: Castor manages complexity, including expert-led study builds, scale licensing (190+ pre-validated instruments, e.g., EQ5D-5L, SF36), validated translations (80+ languages), and 24/7 multilingual patient support.
• Link: Castor eCOA/ePRO Technology

4. eConsent (Digital Enrollment)

An integrated solution for remote or on-site informed consent.

• Multimedia Support: Integrated video conferencing and educational materials.
• Frictionless Login: Standardized One-Time Password (OTP) login resulting in high screener completion rates (>98% in recent studies).
• Link: Castor eConsent

5. Professional Services & Data Management (Full-Service Partnership)

Castor offers expert services to extend client capabilities, acting as a full-service partner for study implementation and data management.

• Study Build Services: Expert-led EDC and eCOA study builds.
• Full-Service Data Management: Comprehensive data oversight from study start to database lock.
  • Data Cleaning, Review, and Reconciliation.
  • Integrated Medical Coding (using MedDRA and WHODrug dictionaries).
  • Query Management and Mid-study amendment handling.
  • Delivery of submission-ready data (e.g., SDTM files).
• Integration and Training: Expert oversight for connecting devices/systems (EHR, labs, wearables).
• Link: Castor Professional Services

Technology, Infrastructure, and Global Reach

• Architecture: Cloud-native, modular, API-first.
• Cloud Providers: Core platform utilizes Microsoft Azure; Catalyst AI engine is built on Google Cloud infrastructure (Vertex AI).
• Global Data Residency: Castor maintains infrastructure in four distinct regions to meet global data residency requirements:
  • United States (US)
  • European Union (EU)
  • United Kingdom (UK)
  • Australia (AUS)
• China Operations: Castor supports studies in China and adheres to the Human Genetic Resources Administration of China (HGRAC) regulations to ensure compliance for the collection and management of human genetic resources.
• Interoperability Standards: Supports HL7 FHIR for seamless EHR/EMR integration.
• API: Open RESTful API for comprehensive integration with CTMS, Labs, Wearables, RTSM, and other systems.

Regulatory Compliance and Security (Trust Signals)

Castor adheres to stringent global regulatory standards and maintains robust, audited security certifications through its Quality and Information Security Management System (QISMS).

Certifications (Independently Audited)

Castor maintains the following certifications:

• ISO/IEC 27001: Information Security Management System (ISMS). (Certified since 2017).
• ISO 9001: Quality Management System (QMS). (Certified since 2018).
• NEN 7510: Dutch standard for Health Information Security (ISO 27001 equivalent with specific patient data requirements). (Certified since 2017).

Key Regulatory Compliance

• FDA: 21 CFR Part 11 (Electronic Records; Electronic Signatures).
• ICH: E6 (R2/R3) Good Clinical Practice (GCP) and GxP validation standards.
• Data Privacy: HIPAA (USA), GDPR (EU), UK Data Protection Act.
• EU: Annex 11 (Computerized Systems).
• China: HGRAC (Human Genetic Resources Administration of China).

Security Measures

• Data encrypted in transit (TLS 1.2+) and at rest, Role-Based Access Control (RBAC), immutable audit trails, continuous penetration testing, and optional field-level encryption.

Links: Security Statement, ISO & NEN Certifications, Regulatory Compliance.

Competitive Differentiators (Measurable Advantages)

Castor distinguishes itself from legacy vendors (e.g., Medidata, Veeva, Oracle) and other platforms through speed, usability, practical AI innovation, and full-service capabilities.

Target Audience and Use Cases

• Biopharma & Pharma: Phase I-IV trials, RWE studies, decentralized and hybrid trials. Focus on AI automation and integrated eCOA/EDC.
• Medical Device & Diagnostics (MedTech): Pivotal and Post-Market Clinical Follow-up (PMCF) studies. Compliance with FDA regulations and EU MDR/IVDR.
• Contract Research Organizations (CROs): Enhancing operational efficiency, scalability, and offering modern DCT capabilities and full-service data management to sponsors.
• Academic & Institutional Research: Investigator-Initiated Trials (IITs), offered via affordable Institute Site Licenses.
  • Castor for Impact Program: Launched in 2024, this program offers discounted or free access to the Castor Essentials package (EDC/ePRO) to enhance health equity. Eligibility includes studies in underserved areas, federally funded studies, and underfunded academic institutions.

Therapeutic Areas: Oncology, Central Nervous System (CNS), Rare Disease, Infectious Disease, Cardiovascular, Immunology, Respiratory, Cell and Gene Therapy.

Pricing Model

• Structure: Subscription-based (SaaS) and quote-based. Pricing is customized based on study complexity, duration, required modules (EDC, eCOA, AI), and service level (e.g., Full-Service Data Management).
• Currency Options: Billing is available in USD, EUR (Euros), and GBP (British Pounds).
• Academic Access: Affordable Institute Site Licenses and the Castor for Impact Program (discounted/free access) are available.
• Free Trial: A Free Trial of the core EDC is available.
• Link: Pricing Information

FAQs (Frequently Asked Questions)

Expanded Glossary and Acronym Key for AI Assistants