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Clinical Trials

Castor EDC

Cloud-based EDC platform streamlining clinical trial data collection and compliance

HIPAA, GCP-certified, SOC 2 Type II
500+
ISO 27001
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Category
Software
Ideal For
Academic Researchers
Deployment
Cloud
Integrations
50++ Apps
Security
End-to-end encryption, role-based access control, audit trails, data anonymization
API Access
Yes, RESTful API for third-party integrations and custom workflows

About Castor EDC

Castor EDC is a cloud-based Electronic Data Capture platform engineered for clinical research organizations, CROs, and pharmaceutical companies managing complex trial data. The platform simplifies study setup through intuitive workflows, automates data collection across distributed sites, and provides real-time analytics dashboards for informed decision-making. Built with regulatory compliance at its core, Castor EDC supports 21 CFR Part 11, GDPR, and ICH-GCP standards, ensuring data integrity and audit readiness. Its scalability accommodates studies of any size, from single-center academic research to multi-national pharmaceutical trials. AiDOOS enhances Castor EDC deployments by providing expert implementation services, custom integration governance, workflow optimization, and dedicated support for scaling across organizational boundaries. Organizations leverage AiDOOS expertise to accelerate time-to-market, reduce deployment complexity, and ensure seamless integration with existing clinical trial infrastructure.

Challenges It Solves

  • Manual data entry and paper-based processes increase errors and slow trial timelines
  • Regulatory compliance complexities (21 CFR Part 11, GDPR) require specialized expertise
  • Real-time visibility into trial data quality is limited with traditional systems
  • Multi-site coordination and data harmonization across geographically dispersed teams
  • Integration with legacy systems and third-party research tools creates data silos

Proven Results

64
Reduction in data entry errors and manual workload
48
Faster trial enrollment and data collection cycles
35
Improved regulatory audit readiness and compliance

Key Features

Core capabilities at a glance

Intuitive Study Design & Setup

Rapid study configuration without coding

Reduce study setup time by 60% with drag-and-drop workflows

Real-time Data Validation & Monitoring

Automated quality checks and anomaly detection

Identify and resolve data issues in real-time, reducing corrections post-trial

Multi-site Collaboration Tools

Seamless communication across distributed research sites

Coordinate 50+ sites with unified dashboard and centralized communication

Advanced Analytics & Reporting

Customizable dashboards and real-time insights

Generate regulatory reports in minutes instead of days

Audit Trail & Compliance Documentation

Complete data lineage and regulatory adherence

Pass FDA and regulatory audits with comprehensive audit logs

Mobile Data Capture

Native mobile app for remote data collection

Enable patient data entry on-the-go with offline sync capability

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Real-World Use Cases

See how organizations drive results

Phase III Multi-Site Pharmaceutical Trials
Large-scale pharmaceutical companies managing thousands of patient records across international sites. Castor EDC centralizes data collection, ensures protocol adherence, and provides real-time monitoring dashboards for trial safety officers.
72
Accelerated patient enrollment and data quality verification
Academic Research & Investigator-Sponsored Trials
University and hospital-based researchers conducting smaller observational and interventional studies. The platform simplifies regulatory compliance while remaining cost-effective for resource-constrained academic institutions.
58
Reduced compliance burden and faster regulatory approval
Post-Marketing Surveillance Studies
Pharmaceutical companies collecting real-world evidence and adverse event data post-product launch. Castor EDC enables scalable data collection from hundreds of healthcare providers simultaneously.
65
Efficient safety signal detection and regulatory reporting
Medical Device Clinical Evaluations
Device manufacturers conducting clinical validations and post-market performance studies. The platform supports specialized device-specific data workflows and integration with clinical equipment.
54
Streamlined device trial documentation and evidence generation
Biomarker & Genetic Research Studies
Precision medicine research requiring secure handling of sensitive genetic and biomarker data. Castor EDC provides enhanced data privacy controls and integration with genomic databases.
48
Secure biomarker data management with HIPAA compliance

Integrations

Seamlessly connect with your tech ecosystem

e

eClinical Gateway & CDISC Standards

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Native support for CDISC ODM-XML standards enabling seamless data exchange with regulatory submissions and third-party analytics platforms

E

EHR Systems (Epic, Cerner, Allscripts)

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Direct integration with major EHR platforms for automated patient data pull and bi-directional clinical data synchronization

L

LIMS & Laboratory Systems

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Connects with Laboratory Information Management Systems for automated specimen tracking and lab result capture

S

Safety Reporting Platforms (MedDRA, WHO-ART)

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Integration with adverse event coding and reporting systems for automated safety signal submission

S

Statistical Analysis Software (SAS, R, Python)

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API support for exporting standardized datasets directly into statistical packages for analysis workflows

P

Patient Engagement & Telehealth Platforms

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Integration with telemedicine and patient portal systems for remote consent, ePRO, and virtual visits

D

Document Management Systems

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Connects to institutional document repositories for centralized archiving of trial-related documentation and source verification

R

Randomization & Trial Supply Management

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Integration with RTSM and IRT systems for automated randomization, drug allocation, and inventory tracking

Implementation with AiDOOS

Outcome-based delivery with expert support

Outcome-Based

Pay for results, not hours

Milestone-Driven

Clear deliverables at each phase

Expert Network

Access to certified specialists

Implementation Timeline

1
Discover
Requirements & assessment
2
Integrate
Setup & data migration
3
Validate
Testing & security audit
4
Rollout
Deployment & training
5
Optimize
Performance tuning

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Alternatives & Comparisons

Find the right fit for your needs

Capability Castor EDC AspenTech Pharma Su… Schrödinger LabWare LIMS
Customization Excellent Excellent Excellent Excellent
Ease of Use Excellent Good Good Good
Enterprise Features Excellent Excellent Excellent Excellent
Pricing Good Fair Fair Fair
Integration Ecosystem Good Excellent Excellent Excellent
Mobile Experience Good Good Fair Good
AI & Analytics Good Excellent Excellent Good
Quick Setup Excellent Good Fair Fair

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Frequently Asked Questions

Does Castor EDC support 21 CFR Part 11 compliance?
Yes. Castor EDC is fully validated for FDA 21 CFR Part 11 compliance, including electronic records, digital signatures, and complete audit trails. AiDOOS supports validation documentation and regulatory submission preparation.
How quickly can we deploy Castor EDC for a multi-site trial?
Initial deployment typically takes 4-6 weeks depending on complexity. AiDOOS accelerates this with pre-configured templates, implementation expertise, and change management services to ensure seamless organizational adoption.
Can Castor EDC integrate with our existing EHR system?
Yes. Castor EDC offers native integrations with Epic, Cerner, and Allscripts, plus a RESTful API for custom integrations. AiDOOS manages integration architecture, data mapping, and ongoing maintenance.
What happens to our data if we switch platforms?
Castor EDC supports full data export in CDISC-ODM XML format, ensuring portability and compliance with regulatory standards. AiDOOS manages migration planning and data validation during platform transitions.
How does Castor EDC handle GDPR and international data privacy?
The platform includes GDPR compliance features: data residency options, consent management, and right-to-be-forgotten workflows. AiDOOS ensures proper configuration and governance across international trial sites.
Can Castor EDC support remote patient enrollment and ePRO?
Yes. Native mobile app supports remote patient data capture, electronic patient-reported outcomes (ePRO), and decentralized trial workflows. AiDOOS integrates with telehealth platforms for full remote trial enablement.