One source of truth for all your trial documents

Stop juggling spreadsheets and shared drives. Clincove's unified eISF and eTMF system ensures every document created at the site is instantly available to sponsors, monitors, and auditors — without a single email attachment.

TMF Reference Model compliant
21 CFR Part 11 eSignatures
Real-time site to sponsor sync
AI-powered document classification
eBinder
01. Trial Management 48
02. Central Trial Docu… 26
03. Regulatory 34
04. IRB or IEC and oth… 19
05. Site Management 12
06. IP & Trial Supplies 8
07. Safety Reporting 15
08. Safety Reporting 7
10. Data Management 22
11 . Statistics 11
Emailed 18
From Sponsor 42
Scanned 9
Type
Name
Status
PDF
Signed Protocol v3.2.pdf
Approved
PDF
Protocol Amendment 04.pdf
Reviewed
PDF
Informed Consent Form (ICF) v2.1.pdf
Approved
PDF
Investigator Brochure v8.0.pdf
Current
PDF
FDA Form 1572.pdf
Approved
PDF
Financial Disclosure Form.pdf
Attention
PDF
Site Delegation Log.pdf
Current
PDF
Training Completion Certificate.pdf
Reviewed
DOCX
Monitoring Visit Report - July 2025.docx
Draft
PDF
Lab Certification (CAP/CLIA).pdf
Approved
PDF
IRB Approval Letter.pdf
Current
PDF
Subject Screening Log.pdf
Attention
How It Works

From upload to audit-ready in seconds

Three steps replace weeks of manual document management

1

Upload or scan

Drag and drop documents, scan directly from paper, or forward emails. AI automatically classifies and routes each file to the correct TMF zone.

2

Sync instantly

Documents appear in both the site eISF and sponsor eTMF simultaneously. Version control, audit trails, and metadata are maintained automatically.

3

Stay audit-ready

Automated completeness checks flag missing documents. When inspectors arrive, generate a read-only inspector view in minutes — not weeks.

Capabilities

Built for modern document management

Everything you need to stay compliant and organized

Real-time Synchronization

When a site uploads a file to their eISF, it appears instantly in the sponsor's eTMF. Complete audit trail maintained automatically.

  • Instant document availability
  • Automatic version control
  • Change tracking with full history

Audit-Ready Compliance

Every document is automatically tagged, indexed, and stored according to TMF Reference Model standards.

  • TMF Reference Model compliance
  • Automated indexing & metadata
  • Inspector view access controls

Smart Classification

AI-powered document classification automatically sorts uploads into the correct TMF zones and sections. OCR extracts text for instant searchability.

  • AI-powered document sorting
  • OCR text extraction
  • Full-text search across all files

21 CFR Part 11 eSignatures

Built-in compliant electronic signatures with identity verification. Full compliance with FDA regulations out of the box.

  • FDA 21 CFR Part 11 compliant
  • Identity verification
  • Complete signature audit trail

Email-to-ISF Ingestion

Forward sponsor emails directly into the eBinder. Attachments are auto-extracted, classified, and filed — no manual downloads.

  • Auto-extract attachments
  • Smart sender recognition
  • Chain-of-custody preserved

Built-in PDF Viewer

View, annotate, and approve documents without leaving the platform. Search within PDFs, rotate, zoom, and compare versions side by side.

  • In-app document viewing
  • Annotation and markup tools
  • Side-by-side version comparison
85%
Faster document retrieval
99.9%
TMF completeness score
0
Email attachments needed
<24hrs
Audit preparation time

Ready to eliminate document chaos?

Join hundreds of sites and sponsors who have unified their eISF and eTMF with Clincove.

No credit card required
SOC 2 & HIPAA compliant
14-day free trial
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