The world's first automated, multi-regulatory clinical trial auditing system. Powered by predictive AI and secured by blockchain technology.
100%
Local Processing
3+
Major Frameworks
256
Bit Encryption
ProtoAudit isn't just a checklist. It's an intelligent engine built on four pillars of advanced compliance logic.
Context-aware rule selection checks patient visits against the protocol version active on that specific date, handling amendments seamlessly.
Uses risk pattern analysis to forecast future violations before they occur, flagging aging system validations or untrained investigators.
Every audit action is hashed (SHA-256) and linked in a cryptographic chain, creating a tamper-evident log for inspectors.
Simultaneous validation against ICH-GCP, FDA 21 CFR Part 11, and CDSCO Indian GCP frameworks in a single pass.
Parses complex Excel datasets (Patients, Investigators, Site Info) securely on your local machine.
Checks not just syntax, but meaning. e.g., "Does this Adverse Event have a corresponding Concomitant Medication?"
Generates a weighted 0-100% compliance score, stratified by violation severity (Critical, Major, Minor).
Intellectual Property of Dr. Mohammed Jaseem Ibrahim
"Manual auditing is slow, expensive, and error-prone. ProtoAudit automates the verification of clinical research data, ensuring patient safety and regulatory compliance through cryptographic certainty."
Dr. Mohammed Jaseem Ibrahim
Inventor & Developer