Cybersecurity engineered for decentralized and remote clinical trials
Maintain continuous defense across connected wearables, home health sensors, and patient records. CySkor isolates remote participant devices, blocks live data interception, and preserves uncompromised regulatory trial integrity from day one.
Active Monitored Endpoints
Select node for perimeter detailsWearable Device • BLE 5.3 / TLS 1.3
Home Ambient Sensor • WPA3 / Zero-Trust
Clinical Data Terminal • CySkor Secure Shield
Health Records Bus • FHIR over mTLS
Safeguard clinical trials across distributed remote networks
Decentralized trials expand patient access but disperse sensitive study data across thousands of unprotected home networks. We protect trial integrity, proprietary formulations, and patient identities from targeted exploitation.
Lessons from the 2024 Change Healthcare breach
The catastrophic 2024 Change Healthcare ransomware attack paralyzed prescription pipelines and clinical billing nationwide, proving that single-point vulnerabilities in healthcare infrastructure halt critical patient operations overnight.
In decentralized clinical trials (DCTs), the perimeter is no longer a fortified campus data center. When remote coordinators and decentralized trial sites access electronic data capture (EDC) systems over home internet, an unmonitored home router becomes the gateway to proprietary study datasets.
Vulnerabilities in decentralized trial setups
Decentralized models introduce friction between regulatory compliance and consumer-grade home networks.
Over 82% of residential routers contain unpatched vulnerabilities that attackers use to intercept unencrypted clinical telemetry.
Adversaries focus on Phase II/III trial data to compromise proprietary molecular structures before patent filings.
Decentralized trial apps without standardized endpoint isolation create blind spots across distributed investigator sites.
Three pillars of clinical trial defense
Engineered specifically for biotechnology sponsors, contract research organizations (CROs), and distributed site networks.
Isolate clinical telemetry and eCRF platforms from unmanaged home devices, default router vulnerabilities, and shared household hardware.
- Zero-trust microsegmentation for trial workstations
- Automated peripheral inspection and USB port locking
- Encrypted local scratch space for patient data capture
Assess the unique threat surface of each principal investigator, clinical research coordinator, and decentralized patient hub.
- Continuous WiFi router firmware and configuration checks
- Real-time spear-phishing simulation tailored to trial protocols
- Proactive credential exposure monitoring across dark web feeds
Maintain audit-ready electronic records that meet 21 CFR Part 11 and international trial integrity standards without slowing research.
- Tamper-proof audit logging for every remote record touch
- Pre-configured regulatory mapping for FDA, EMA, and HIPAA
- Instant incident reporting dossiers for ethics committees
Protecting phase trials from protocol deviation and data tampering
When endpoint integrity is compromised, regulatory submissions can be invalidated, setting life-saving therapies back by years. CySkor provides remote workers with real-time risk alerts and security hardening, ensuring every investigator workstation meets continuous FDA and HIPAA requirements.