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Secure Health Research Data Management Platform

stratoflow.com

Medical

Health & Fitness

Information technology

Challenges in Health Research Data Management

Research organizations face data integrity risks from inconsistent collection methods, participant bias, and security vulnerabilities. Existing systems lack robust encryption, audit capabilities, and regulatory compliance frameworks, leading to potential breaches and compromised study validity.

About the Client

Research organization conducting clinical and public health studies requiring secure data collection and analysis

Goals for the New Data Management System

Implement secure, compliant data collection workflows
Eliminate participant bias through standardized protocols
Ensure end-to-end data encryption and access controls
Maintain complete audit trails for regulatory compliance
Improve data reliability for healthcare decision-making

Core System Functionalities

Encrypted electronic data capture forms
Role-based access control with multi-factor authentication
Automated audit trail generation
Data validation and bias detection algorithms
Compliance reporting dashboard (HIPAA/GDPR)

Technology Stack Requirements

REDCap

AWS KMS encryption

Docker containers

Kubernetes orchestration

System Integration Needs

Electronic Health Records (EHR) systems
Statistical analysis tools (R/Python)
Identity management platforms (Okta)
Cloud storage services (AWS S3)

Operational Requirements

99.99% system availability with failover redundancy
Real-time data encryption at rest and in transit
Support for 10,000 concurrent users
Compliance with 21 CFR Part 11 standards
Disaster recovery RTO <2 hours

Expected Business Impact

Implementation of this platform will reduce data breach risks by 90%, decrease compliance audit preparation time by 60%, and improve research data accuracy by 75%. The organization will achieve faster study approvals through automated compliance workflows while maintaining complete data integrity for evidence-based healthcare decisions.