FDA & HIPAA Validated Architecture

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.

14,820Active Trial Endpoints100% Isolated
99.999%Data Integrity RateZero Tampering
< 0.001sAnomalous Packet DropReal-time Defended
CySkor Telemetry Node v4.19
Site #042 | Protocol RCT-9182-ONC
LIVE SHIELD ACTIVE
Zero-Trust BusHardened mTLS100% Policy Bound
Edge Sensor Load1.2% MemoryZero Battery Drain
Audit TrailImmutable LogCryptographic Hash

Active Monitored Endpoints

Select node for perimeter details
Continuous CGM BiosensorEP-01

Wearable Device BLE 5.3 / TLS 1.3

14msEncrypted & Active
Home Spirometry GatewayEP-02

Home Ambient Sensor WPA3 / Zero-Trust

28msProtected Stream
ePRO Patient Diary TabletEP-03

Clinical Data Terminal CySkor Secure Shield

19msVerified & Synced
Decentralized EHR Vault ConnectorEP-04

Health Records Bus FHIR over mTLS

42msCompliant Tunnel
Tactical Inspection: Continuous CGM Biosensor
ENCRYPTION SUITEAES-256 GCM
RISK VECTOR SCORE0.02 (Nominal)
TAMPER INTEGRITYAttestation Validated
Clinical research protection

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.

Vulnerabilities in decentralized trial setups

Decentralized models introduce friction between regulatory compliance and consumer-grade home networks.

Unsecured home routers

Over 82% of residential routers contain unpatched vulnerabilities that attackers use to intercept unencrypted clinical telemetry.

Targeted drug IP theft

Adversaries focus on Phase II/III trial data to compromise proprietary molecular structures before patent filings.

Unverified third-party tools

Decentralized trial apps without standardized endpoint isolation create blind spots across distributed investigator sites.

Strategic defense architecture

Three pillars of clinical trial defense

Engineered specifically for biotechnology sponsors, contract research organizations (CROs), and distributed site networks.

Pillar 01
Home-based endpoint hardening

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
Pillar 02
Personalized vulnerability profiling

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
Pillar 03
Continuous FDA & HIPAA compliance

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
Data Integrity & Patient Privacy

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.