EDC - Electronic Data Capture for Cancer Care
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.
Duration
14 months
Role
Technology Partner
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
Implementation
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
Key Features
Impact & Results
This project delivered measurable results and significant value to users and stakeholders.