ProtoAudit

Automated Clinical GCP Auditor

Only for Mac

$1,000.00

Mac

The world's first patent-pending automated clinical auditor. Verify ICH-GCP, 21 CFR Part 11 & CDSCO compliance with predictive AI and blockchain-secured logging. The Future of Clinical Compliance is Here. ProtoAudit represents a paradigm shift in clinical trial quality assurance. Developed by Dr. Mohammed Jaseem Ibrahim, this patent-pending application transforms the traditional, manual auditing process into a precise, automated workflow. Manual data verification is slow, expensive, and prone to human error. ProtoAudit eliminates these risks by using advanced algorithms to audit clinical datasets against complex study protocols and multiple regulatory frameworks simultaneously—in seconds. CORE CAPABILITIES: Multi-Regulatory Framework Support Stop checking rules one by one. ProtoAudit simultaneously validates your data against: ICH-GCP (E6 R2): Investigator qualifications, informed consent, and essential documents. FDA 21 CFR Part 11: Electronic system validation, digital signatures, and audit trail requirements. CDSCO Indian GCP: Ethics committee approvals and local reporting timelines. Predictive Compliance Engine Move from reactive to proactive. The built-in predictive engine analyzes current data to forecast future risks, such as: Identifying investigators with expiring GCP training. Flagging aging system validations before they become non-compliant. Detecting at-risk patient cohorts based on protocol deviation patterns. Cryptographic Blockchain Audit Trail Inspection readiness is built-in. Every audit action, import, and analysis is cryptographically hashed (SHA-256) and linked in a tamper-evident blockchain ledger. Verify the integrity of your audit history with mathematical certainty. Temporal Protocol Logic Clinical trials change. ProtoAudit understands that. The engine applies the correct protocol rules (inclusion/exclusion criteria, visit windows) based on the specific effective date of the event, handling protocol amendments seamlessly. KEY FEATURES: Semantic Safety Analysis: Intelligently correlates Adverse Events (AEs) with Concomitant Medications to detect missing safety data. Quantitative Scoring: Generates a weighted "Compliance Health Score" (0-100%) stratified by violation severity (Critical, Major, Minor). Instant Reporting: Export detailed PDF inspection reports and JSON data extracts with a single click. Excel Data Ingestion: Drag-and-drop import for standard Patient, Investigator, and Site datasets. PRIVACY & SECURITY: 100% On-Device Processing. ProtoAudit respects patient privacy. All data parsing, logic validation, and report generation occur locally on your Mac. No sensitive clinical data is ever uploaded to the cloud. ProtoAudit is the essential tool for Sponsors, CROs, and Clinical Research Auditors demanding speed, accuracy, and integrity.

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The developer, Mohammed Jaseem Ibrahim K, indicated that the app’s privacy practices may include handling of data as described below. For more information, see the developer’s privacy policy .

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    Information

    • Seller
      • Mohammed Jaseem Ibrahim K
    • Size
      • 5.8 MB
    • Category
      • Productivity
    • Compatibility
      Requires macOS 14.6 or later.
      • Mac
        Requires macOS 14.6 or later.
    • Languages
      • English
    • Age Rating
      4+
    • Copyright
      • © Dr. Mohammed Jaseem Ibrahim K.
  • Developer Website
  • Privacy Policy

    • Supports

    • Family Sharing

      Up to six family members can use this app with Family Sharing enabled.