Clinical Data Modernization
Clinical Data Modernization
Clinical Data Modernization
Build and optimize secure, compliant data ecosystems for decentralized and hybrid trials.
- Design modern data-lake and governance frameworks aligned with CDISC / SDTM / ADaM standards.
- Integrate EDC, CTMS, and LIMS systems with unified cloud architectures.
- Enable automated lineage and traceability from source to submission.
AI & Analytics Consulting
Clinical Data Modernization
Clinical Data Modernization
Harness artificial intelligence to improve participant engagement and operational efficiency.
- Apply machine learning for recruitment prediction, retention optimization, and anomaly detection.
- Use natural-language processing (NLP) to extract insights from consent and AE narratives.
- Develop dashboards and real-time study-performance visualizations.
Secure Cloud Modernization
Clinical Data Modernization
Secure Cloud Modernization
Modern, scalable, compliant architectures across.
- AWS (Lambda, Glue, Redshift, KMS)
- Azure (Key Vault, Form Recognizer, Databricks)
- Snowflake (Cortex, secure data sharing)
- Databricks (Unity Catalog, ML/GovCloud pipelines)
Quantum-Safe & Cybersecurity Services
Quantum-Safe & Cybersecurity Services
Quantum-Safe & Cybersecurity Services
Prepare for NIST/NSA PQC mandates.
Deliverables
- PQC readiness assessment
- Cryptography inventory
- Secure key management plan
- Identity governance hardening
- Compliance roadmap for HIPAA/FISMA/FedRAMP
- Cloud crypto modernization
Regulated Data Engineering
Quantum-Safe & Cybersecurity Services
Quantum-Safe & Cybersecurity Services
We specialize in secure, compliant engineering for PHI/PII and government workloads.
Capabilities
- Cloud-native ETL/ELT pipelines
- GovCloud migrations
- API integration & identity governance
- Audit-ready logging & monitoring
- Secure data lakes & analytic platforms
Compliance & Regulatory Automation
Quantum-Safe & Cybersecurity Services
Compliance & Regulatory Automation
Automate routine quality and compliance workflows to reduce risk and improve audit readiness.
- Continuous monitoring for HIPAA, GDPR, and FDA 21 CFR Part 11 compliance.
- AI-driven checks for investigator debarment, credential expiration, and subject privacy.
- Digital QMS modernization and validation documentation support.