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Clinical Data Architecture
EDC - Electronic Data Capture for Cancer Care
Clinical intelligence system structuring unstructured oncology data for advanced predictive modeling.
AngularJava Spring BootMySQLFHIRHL7
Overview
An Electronic Data Capture (EDC) system designed specifically for oncology departments to manage patient data, treatment protocols, and clinical research. The platform ensures HIPAA compliance while streamlining cancer care workflows.
The Challenge
- Manual paper-based patient data collection was error-prone and time-consuming
- Lack of standardization in cancer treatment data across facilities
- Difficulty in tracking patient treatment progress and outcomes
- Challenges in aggregating data for clinical research
- No centralized system for multi-site clinical trials
- Compliance requirements for patient data security and privacy
How We Built It
Clinical Data Management
Comprehensive system for capturing and managing patient clinical data
- Designed customizable electronic case report forms (eCRFs)
- Implemented CTCAE (Common Terminology Criteria for Adverse Events) integration
- Built treatment protocol management with dosing calculators
- Created patient timeline visualization showing treatment journey
- Developed automated data validation and quality checks
- Implemented audit trails for all data modifications
Interoperability & Standards
Integration with healthcare systems using industry standards
- Implemented FHIR (Fast Healthcare Interoperability Resources) APIs
- Built HL7 message processing for lab results and imaging
- Integrated with hospital EHR systems
- Created DICOM viewer for medical imaging
- Developed data export in CDISC standards for regulatory submissions
Clinical Trial Management
Tools for managing multi-site clinical research studies
- Built study protocol configuration system
- Implemented patient randomization and stratification
- Created site management and monitoring tools
- Developed adverse event reporting workflow
- Built query management system for data clarifications
- Implemented electronic signatures for regulatory compliance
Security & Compliance
Enterprise-grade security meeting healthcare regulations
- Achieved HIPAA compliance with end-to-end encryption
- Implemented role-based access control (RBAC)
- Built comprehensive audit logging system
- Created data anonymization for research datasets
- Developed disaster recovery and backup systems
- Implemented 21 CFR Part 11 compliance for electronic records
Results
$400K/yr
Clinical ops cost reduced
25+
Clinical Trials Managed
99.7%
Data Accuracy
60%
Staff time reclaimed
Duration
14 months
Our Role
Technology Partner
