iDox.ai Redact – Life Science Edition
Precision Redaction for Pharmaceutical & Clinical Research Compliance. Faster regulatory approvals start with faster, compliant redaction.
Streamline Regulatory Submissions with AI-Powered Redaction
In the life sciences industry, redaction isn’t just about removing sensitive data—it’s a two-step regulatory process requiring precision, auditability, and compliance with strict guidelines like EMA Policy 70, EU CTR 536/2014, and Health Canada PRCI.
iDox.ai Redact Life Science Edition is the first AI-driven solution designed specifically for pharmaceutical companies, CROs, and research facilities, automating redaction workflows while ensuring full compliance with global regulatory standards.
iDox.ai Redact Life Science Edition is the first AI-driven solution designed specifically for pharmaceutical companies, CROs, and research facilities, automating redaction workflows while ensuring full compliance with global regulatory standards.
Why Life Science Redaction is Different
Unlike standard document redaction, life science submissions require:
Auto scan result highlight
Authority approval
Apply redaction
1. Pre-approval Phase: Highlight and justify proposed redactions (PPD, CCI) before authority approval.
2. Post-approval Execution: Apply final redactions only after regulatory confirmation.
Manual processes are error-prone, time-consuming, and risky—leading to delays, non-compliance penalties, or data breaches. iDox.ai Redact automates both phases while maintaining a defensible audit trail.
2. Post-approval Execution: Apply final redactions only after regulatory confirmation.
Manual processes are error-prone, time-consuming, and risky—leading to delays, non-compliance penalties, or data breaches. iDox.ai Redact automates both phases while maintaining a defensible audit trail.
Key Features for Life Science Compliance
01Two-Step Regulatory Redaction Workflow
Step 1: Proposal Mode – AI identifies and highlights sensitive data (patient IDs, trial site details, CCI) and generates a regulator-ready justification report for pre-submission review.
Step 2: Enforcement Mode – Once approved, apply redactions in one click with cryptographic removal (not just black boxing) to meet EMA, FDA, and Health Canada standards.
Step 2: Enforcement Mode – Once approved, apply redactions in one click with cryptographic removal (not just black boxing) to meet EMA, FDA, and Health Canada standards.
02Pre-Built Compliance Templates
Tailored for EMA Policy 70, EU CTR 536, HIPAA, and more – Pre-configured rules for anonymizing clinical reports, protocols, and CSRs.
Customizable redaction profiles – Adapt to specific trial requirements or regional regulations.
Customizable redaction profiles – Adapt to specific trial requirements or regional regulations.
03AI-Powered Detection with Human Oversight
Natural Language Processing (NLP) identifies PPI (Protected Patient Information) and CCI (Commercially Confidential Information) across 47+ file formats.
Medical & clinical trial-specific lexicons – Recognizes trial codes, adverse event terms, and investigator details unique to life sciences.
Medical & clinical trial-specific lexicons – Recognizes trial codes, adverse event terms, and investigator details unique to life sciences.
04Audit Trail & Compliance Reporting
Full transparency – Track every redaction suggestion, modification, and approval with timestamps and user IDs.
Automated compliance certificates – Generate documentation proving adherence to GDPR, HIPAA, and EMA requirements.
Automated compliance certificates – Generate documentation proving adherence to GDPR, HIPAA, and EMA requirements.
05Secure Collaboration & Version Control
Role-based access – Allow medical writers, regulatory teams, and legal reviewers to collaborate without exposing raw data.
Compare pre- and post-redaction versions – Ensure no over-redaction or accidental disclosures.
Compare pre- and post-redaction versions – Ensure no over-redaction or accidental disclosures.
How iDox.ai Redact Solves Life Science Challenges
Challenges
Manual Process
iDox.ai Solution
Pre-approval justification
AccuracyManual highlighting + Word/PDF markups
Outdated methodAI suggests redactions with auto-generated rationale
AI Powered solutionPost-approval execution
SecurityError-prone manual blackouts
Outdated methodCryptographic data removal (AES-256)
AI Powered solutionMulti-document scaling
ScaleWeeks per submission
Outdated methodBatch processing for 50,000+ pages/month
AI Powered solutionRegulatory changes
ComplianceConstant policy updates
Outdated methodAuto-updating compliance templates
AI Powered solutionWhy Life Science Companies Choose iDox.ai
95% faster than manual redaction– Cut submission timelines from weeks to hours
95%
Time Saving
99% accuracy – AI reduces human error in identifying sensitive data
99%
Accuracy
End-to-end encryption – SOC2 & ISO 27001 certified, with secure deletion of source files
100%
Security Compliance
Cost-efficient – Save $1M+/year vs. outsourcing redaction
$1M+
Annual saving
Get Started with iDox.ai Redact – Life Science Edition
For enterprise
Custom deployments
(cloud/on-prem)
Flexible deployment options tailored to your infrastructure needs
Priority regulatory support
Dedicated compliance expertise for life sciences regulations
Volume-based pricing
Scalable pricing that grows with your document processing needs