PDF SDK for Clinical Trial Document Redaction
Redact PII and confidential commercial information in CSRs, protocols, and regulatory submissions. True content removal for EMA Policy 0070, FDA, and ICH compliance.
Typical PII We Detect & Redact
Clinical Trials Document Challenges
EMA Policy 0070 requires public disclosure of clinical data with PII removed
Manual redaction of 1000+ page CSRs takes weeks and is error-prone
Sponsor and site identifiers scattered across headers, footers, and tables
Audit trail needed to prove what was redacted and why
Use Cases
CSR Redaction for Regulatory Submission
Detect and redact PII across entire Clinical Study Reports in one call. ML-based detection with RECALL optimization to minimize missed entities in compliance-critical submissions.
Selective Entity Redaction
Redact only specific PII categories — e.g. remove dates, addresses, and device identifiers but keep investigator names for regulatory reviewers.
TMF Batch Processing with Audit Trail
Process entire Trial Master File exports at once. Every finding is logged with entity type, confidence, and location — ready for regulatory inspection.
Clinical Trials Workflow
Redact CSRs for EMA Policy 0070 public disclosure
Strip subject identifiers, investigator names, and site addresses from Clinical Study Reports before mandatory public disclosure.
Anonymize protocols for new site distribution
Remove sponsor contacts and site-level addresses before distributing protocols to newly onboarded investigator sites.
Clean TMF documents for sponsor transfer or archival
Batch-redact PII across Trial Master File packages — informed consent forms, adverse event reports, and monitoring visit logs — when transferring between CROs or archiving closed studies.
Compliance Support
Security & Procurement
Why PDFDancer
- True Text Editing: Modify existing content in place, not overlays
- Semantic Selection: Find content by line, paragraph, or pattern
- Permanent Redaction: Content is removed, not just hidden
- Self-Hosting Available: Keep data in your environment
Let’s Talk About Your Use Case
15-minute call — we’ll walk through your document pipeline and show how PDFDancer fits.