The Challenge
A global CRO managing clinical data across AWS and on-prem servers faced growing concerns around:
- HIPAA and GDPR compliance across data zones
- Increased cyber threats during remote trials post-COVID
- Unsecured data flows between internal and sponsor systems
- Lack of centralized visibility for user access, data movement, or breach detection
- Unstructured logs making audit response time-consuming and error-prone
The organization had recently failed a client security audit, prompting immediate need for risk mitigation, validation, and cloud-hardening.
Our Solution
Agile Genix deployed a cybersecurity task force with deep expertise in life sciences infrastructure to transform their environment from reactive to proactively secure and audit-ready.
✅ Security Architecture Assessment
Mapped cloud-to-on-prem data flow, evaluated identity management gaps, and identified weak access points.
✅ HIPAA & GDPR Compliance Frameworks
Implemented security policies and data governance protocols aligned with both HIPAA and GDPR.
✅ Zero Trust Access Controls
Redesigned IAM policies using role-based access, MFA, geo-fencing, and conditional access — enforcing least privilege.
✅ SIEM & Threat Monitoring Integration
Deployed Splunk for log aggregation, set up real-time threat alerts, and built dashboards for IT and compliance teams.
✅ Audit-Ready Documentation & Testing
Delivered full validation documentation (IQ/OQ/PQ), encryption policies, and incident response playbooks.
Impact Delivered
- Secured 10+ connected cloud/on-prem systems under one policy framework
- Reduced unauthorized access risks by 95% via Zero Trust controls
- Achieved HIPAA & GDPR compliance across dual-region data environments
- Improved audit response time from 2 days to 2 hours
- Real-time threat alerting reduced breach detection lag by >60%
Need to Harden Your Hybrid Clinical Infrastructure?
Whether you’re operating across cloud, on-prem, or both — we help life sciences companies achieve end-to-end visibility, defense, and compliance.
Schedule a Security Readiness Audit
Let us evaluate and elevate your cybersecurity posture.