| 開發人員: | Mohammed Jaseem Ibrahim K (3) | ||
| 價錢: | $1000.00 | ||
| 排名: | 0 | ||
| 評測: | 0 寫評論 | ||
| 清單: | 0 + 0 | ||
| 點數: | 0 + 0 ¡ | ||
| Mac App Store | |||
描述
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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新功能
- 版本: 1.4
- 發佈日期:
價錢
- 今天: $1000.00
- 最小值: $1000.00
- 最大值: $1000.00
追蹤票價
開發人員
- Mohammed Jaseem Ibrahim K
- 平台: macOS 應用程式 (3)
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其他資訊
- 版本: 1.4
- 類別 :
macOS 應用程式›生產應用 - OS:
macOS,macOS 14.6 以上版本 - 大小:
2 Mb - 支援的語言 :
English - 內容分級:
4+ - Mac App Store 評分:
0 - 發佈日期:
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聯絡人
- 個人網站:
https://protoaudit.in/
ProtoAudit 縮短網址: 已複製!- 🌟 分享
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