EDC

Castor's Electronic Data Capture (EDC) / Clinical Data Management System (CDMS) is a leading, end-to-end eClinical platform designed to help clinical research teams capture, process, and integrate study data with speed and confidence. Built for sponsors, CROs, and research sites of all sizes, Castor EDC ranks among the top 5% of EDC software providers for shortest platform build time, enabling teams to deploy low-complexity studies in as little as 3–4 weeks and reduce overall build times by up to 63%. The platform is designed with usability in mind, requiring no advanced technical expertise to get started.

Castor EDC/CDMS serves as a centralized hub for all electronic study data, and can be extended with eConsent and ePRO modules to form a complete clinical research data management ecosystem. With over 500 trusted partners and recognition as a Major Contender in the Everest Group's PEAK Matrix® of Life Sciences Electronic Data Capture Products Assessment 2024, Castor is a proven choice for modern clinical trials.

Rapid Study Deployment

• Build advanced eCRFs in minutes using a low-code eCRF Builder, accessible to users regardless of technical background.
• Deploy low-complexity clinical trial EDC in as little as 3–4 weeks.
• Navigate study complexities with best-in-class customer support available throughout the study lifecycle.
• Set up studies independently with no formal training required.

Unified Clinical Trial Data Across Systems

• Integrate study data from EHR, eCRF, ePRO/eCOA, laboratory systems, wearables, and other devices into a single clinical trial data environment.
• Eliminate data silos and manual reconciliation by centralizing clinical trial data capture and integrations.
• Work seamlessly with existing systems and vendors using Castor's open API and extensible integration framework.
• Easily edit forms mid-study to accommodate protocol amendments without disrupting ongoing data collection.

Real-Time Visibility into Study Progress

• Track study progress as it happens with live dashboards showing enrollment, data entry status, and key study metrics.
• Identify data gaps and delays early by monitoring outstanding queries and incomplete records across sites.
• Oversee Source Data Verification (SDV) status to ensure timely verification and regulatory readiness.
• Maintain continuous oversight of study health with greater than 99.9% platform uptime and 100% data integrity, without relying on manual reporting or data exports.

Compliant eCRF Design and Data Collection

• Start with pre-built, validated eCRF templates designed specifically for clinical trials.
• Customize forms using multiple field types and conditional logic to match protocol requirements.
• Reuse and clone eCRFs across studies to accelerate startup and ensure consistency.
• Save study data in real time within the EDC platform.
• Store data on certified, compliant servers in supported regions worldwide.
• Safeguard records with field-level encryption, two-factor authentication, and long-term data retention.

Protocol Amendment Management

• Manage amendments in a secure, traceable, and validation-friendly environment.
• Maintain full audit trails for every change made throughout the study.
• Create separate test environments to validate updates before deployment, reducing operational and compliance risk.

Global Regulatory Compliance

• Comply with FDA 21 CFR Part 11, ICH GCP, GDPR, HIPAA, ISO 27001, and ISO 9001.
• Align with HL7 FHIR and other clinical data standards.
• Support global studies with consistent compliance across sites and countries, ensuring inspection readiness from day one.

Fully Integrated Clinical Trial Workflows

• Recruit, screen, and consent patients remotely via dedicated landing pages, prescreening tools, and video-enabled informed consent.
• Connect all Decentralized Clinical Trial (DCT) components and support direct electronic data capture in the field via eSource.
• Engage study participants through ePRO and eCOA solutions, including user-friendly mobile diary apps accessible from home.
• Implement remote enrollment, screening, eConsent, and data capture within a single platform.
• Combine data from eCRF, eCOA, ePRO, wearables, and EHR sources on one unified platform.

Platform Tiers and Scalability

• Electronic data capture and reporting: Start with core EDC for collecting, processing, and reporting clinical trial data, with dynamic dashboards for study health visibility and the ability to add virtual elements as needs grow.
• eSource and integrations: Connect all clinical data in one centralized system, integrating data from devices, EHRs, EDC, and non-CRF sources, with flexible mid-study form editing.
• All-in-one clinical trial platform: Build a full ecosystem of research tools supporting the entire trial lifecycle, from remote enrollment and eConsent through to ePRO engagement and unified data analysis.

Castor EDC is a validated, cloud-based platform supporting regulatory compliance across global regions and regulatory bodies. With an open API, broad integration capabilities, and compatibility with standards such as HL7 FHIR, Castor integrates into existing clinical research ecosystems while providing the scalability to support studies of any complexity.