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.
Managed operations that stay validated.
Every change, fix, and AI action leaves the evidence an inspector expects.
Risk assessment
Each system and change classified by GxP impact.
Qualify
IQ, OQ, and PQ evidence for platforms and releases.
Change control
Every change approved, tested, and documented.
Periodic review
Access, audit trails, and configuration checked on schedule.
We operate to GxP · 21 CFR Part 11 · EU Annex 11 · GAMP 5 · HIPAA · GDPR
Agents propose, people approve
Agents propose fixes and changes and never apply them alone. Qualified people approve them inside your change-control process, and the audit trail and test records are collected for inspection.
GxP-qualified platforms
We run GxP-qualified data and analytics platforms for life sciences clients today, on validated AWS and Google Cloud environments.
From the lab to the field, run to one standard.
Lab and research data
LIMS, electronic lab notebooks, and research data platforms.
Trial systems
CTMS, EDC and eTMF, and trial data and analytics.
Quality systems
QMS, document control, and training records.
Plant systems
MES, batch records, and equipment data.
Pharmacovigilance
Case intake and signal reporting.
Field and medical teams
CRM, medical affairs, and market data.
Across all of them: Level 1 to 3 application support with validated releases, data platform operations, qualified cloud infrastructure with disaster recovery, and one service desk for lab, field, and office users.
Capability centers for pharma and biotech.
Hyderabad is India's hub for life sciences and pharma capability centers. We help you set one up and run it.
Centers of excellence
Data, AI, and clinical centers of excellence, a senior architect seed team, and GxP-trained talent.
Validated from day one
Validated GxP environments, managed AWS and Google Cloud, and GxP, HIPAA, and GDPR monitoring.
More value per seat
Data platform operations, test and workflow automation, and DevOps with CI/CD and infrastructure as code.
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.
Epic, MyChart, Agent Factory, Art, Emmie, and Penny are trademarks of Epic Systems Corporation. MEDITECH and Expanse are trademarks of Medical Information Technology, Inc.