Your Clinical Trial Data
Is One Audit Away From
A Regulatory Crisis.
Pharma companies and CROs in India lose years of work — and millions in investment — to data integrity failures. We build tamper-proof, FDA 21 CFR Part 11 compliant clinical data systems using Blockchain + AI. Before the auditors arrive.
Book Your Free Data Integrity Audit →No commitment. Personal response within 24 hours. 18 years pharma experience.
⚠ The Data Integrity Crisis Hitting Indian Pharma Right Now
Pharma Companies
FDA 483 observations and Warning Letters for data integrity failures cost Indian manufacturers millions in remediation and lost US market access every year.
CROs in India
Manual audit trails, spreadsheet-based data management, and siloed systems expose CROs to sponsor audits that can terminate contracts overnight.
US Pharma Sponsors
Outsourcing trials to India without a verifiable, immutable data chain creates regulatory exposure in FDA submissions — a risk no sponsor can afford post-2024.
Blockchain + AI Clinical Data Systems
Built for Indian Pharma.
We architect and deploy immutable clinical data pipelines that combine blockchain’s tamper-proof ledger with AI-powered anomaly detection — so your data integrity is provable, auditable, and regulatory-ready.
Immutable Audit Trails
Every data entry, edit, and deletion is cryptographically signed and stored on a permissioned blockchain — making tampering technically impossible and automatically documented for FDA review.
Real-Time Anomaly Detection
AI monitors your clinical data streams 24/7, flagging statistical anomalies, outliers, and protocol deviations before they become audit findings — not after.
FDA 21 CFR Part 11 Ready
Built-in electronic signature workflows, access controls, and audit log exports that satisfy FDA, CDSCO, and ICH E6 GCP requirements out of the box.
Works With Your Existing EDC
Plug into Medidata Rave, Oracle Clinical, REDCap, or custom in-house systems. No rip-and-replace — we add the blockchain integrity layer on top of what you already use.
One-Click Regulatory Export
Generate complete, timestamped audit trail reports in FDA-submission format in seconds — not weeks of manual documentation before an inspection.
Zero Cloud Dependency Option
For sensitive trial data that cannot leave your facility — we deploy edge AI nodes with local blockchain validation. Same integrity guarantee, fully on-premises.
From Audit Risk to Audit-Ready
in 4 Steps.
Data Integrity Audit
We map your current clinical data flow, identify every vulnerability point, and produce a written risk report within 5 business days.
Architecture Design
We design a blockchain + AI layer specific to your study type, EDC system, and regulatory target — FDA, CDSCO, EMA, or all three.
Pilot Deployment
We deploy on one active study or one site first — proving the system works in your real environment before full rollout.
Scale and Monitor
Roll out across studies and sites with ongoing AI monitoring, quarterly integrity reports, and retainer support for regulatory questions.
If Your Trial Data Lives in
Spreadsheets or Siloed Systems — This Is For You.
Indian Pharma Companies
- Received or fear FDA 483 observations
- Expanding into US or EU regulated markets
- Running Phase II / III clinical trials
- Managing multi-site bioequivalence studies
Contract Research Organizations
- Managing data for multiple sponsors
- Under pressure to prove GCP compliance
- Looking to differentiate on data quality
- Preparing for sponsor or regulatory audits
US Pharma Sponsors in India
- Outsourcing trials to Indian CROs
- Need verifiable data chain for FDA submissions
- Require real-time visibility into site data
- Expanding India operations post-2025
Stop Hoping Your Data Holds Up.
Make It Provably Unbreakable.
Book a free 30-minute data integrity audit call. I personally review your current clinical data setup and tell you exactly where your regulatory exposure is — and how blockchain fixes it.
Book Your Free Audit Call →Mahadev Mukherjee · Head of AI Transformation, Bajoria Group · Founder, GARBHAYAN AI · Published Researcher