Public cloud in healthcare and life sciences
Validated environments with Part 11 controls
Certified cloud and data platforms
Normalized EHR data for study-grade cohorts
Submissions, validation, and evidence.
Validation at audit
IQ/OQ/PQ, traceability, and Part 11 controls built alongside the system, ready before the inspection.
Clinical data platforms
EDC, CTMS, and safety-system integration on a normalized data layer, with lineage that survives inspection.
Enrollment risk
Site selection on survey data misses where patients receive care.
From validated cloud to study-grade cohorts.
Senza ARC
Protocol feasibility, site selection, and enrollment monitoring on real populations.
Rosetta
Computable endpoints from normalized EHR data for RWE and post-approval commitments.
Validated Cloud
AWS and Google Cloud environments with qualification packages and continuous GxP monitoring.
AI Governance for Regulated Use
Model inventory, validation evidence, and human-review gates aligned to FDA guidance on AI in drug development.
Technology Solutions
Interoperability, data platforms, and hosting under one SLA.
Trust Center
HITRUST r2, ISO 27001, GxP, and the documentation package.
How we engage.
Assess
Current-state review of systems, validation posture, and data flows against the submissions ahead.
Build
Named senior consultants embedded with your quality and data teams, delivering against the validation plan.
Sustain
Managed support and periodic revalidation as platforms, protocols, and guidance change.
Thirty minutes with the Senza ARC and validated-cloud leads.
Scoped to the study, with your quality and data leads in the room.
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