Clinical Trial Management

eTMF Management That's Always Inspection-Ready

Stop scrambling before FDA inspections. AI-powered document management that keeps your Trial Master File complete, organized, and compliant from study startup to close-out.

50%
Faster Document Filing
75%
Reduced Site Queries
90%
Inspection Ready
30%
Lower CRO Costs

Sound Familiar?

Clinical trial document management challenges that keep you up at night

eTMF Chaos

Study documents scattered across shared drives, email, and paper files

Impact: FDA inspection findings, delayed submissions

Protocol Deviations

Tracking deviations, amendments, and IRB correspondence manually

Impact: Compliance gaps, audit findings

Site Document Collection

Chasing sites for missing documents, regulatory updates, training records

Impact: Enrollment delays, monitoring inefficiencies

Inspection Readiness

Scrambling to compile documents when FDA/EMA announces inspection

Impact: Stress, overtime, potential findings

TMF Reference Model Compliant

AI auto-classifies documents into the correct eTMF zones based on DIA TMF Reference Model

Zone 1

Trial Master File

TMF Index, Filing Instructions, Signature Logs

Zone 2

Central Trial Docs

Protocol, IB, ICF Templates, Safety Reports

Zone 3

Regulatory

FDA Correspondence, IND/NDA, Annual Reports

Zone 4

IRB/IEC

Approvals, Amendments, Continuing Reviews

Zone 5

Site Level

Site Selection, Training, Monitoring Visits

Zone 6

IP & Lab

Drug Accountability, Lab Certifications, Kits

Zone 7

Safety Reports

SAEs, SUSARs, Safety Narratives

Zone 8

Statistics & Data

SAP, Data Management Plans, Databases

Complete Study Lifecycle Coverage

From first-patient-in to database lock and beyond

Study Startup

  • Protocol finalization & approval tracking
  • IRB/IEC submission & approval management
  • Site selection documentation
  • Regulatory submission packages
  • Site initiation visit checklists

Study Conduct

  • Monitoring visit reports & follow-up
  • Protocol deviation tracking
  • Amendment management & distribution
  • Safety report processing
  • Site correspondence tracking

Study Close-out

  • Site close-out visit documentation
  • Final regulatory notifications
  • eTMF completeness review
  • Archival preparation
  • Inspection readiness verification

Calculate Your eTMF ROI

See how AI-powered document management reduces trial costs

Typical Study Savings

Document filing time-50%
Site query resolution-75%
Inspection prep time-80%
TMF QC effort-60%

Example: Phase II Study

20 sites, 24 months
Traditional TMF management$180,000
With Documenter AI$72,000
Annual Savings$108,000

Built for Clinical Compliance

Meet regulatory requirements with confidence

21 CFR Part 11

Electronic records & signatures

ICH E6 (R2) GCP

Good Clinical Practice guidelines

TMF Reference Model

DIA eTMF structure

EU CTR

European Clinical Trials Regulation

ALCOA+

Data integrity principles

FDA/EMA Inspections

Regulatory inspection readiness

Connects to Your Clinical Systems

Veeva Vault(eTMF)
Medidata Rave(EDC)
Oracle Clinical(CTMS)
Veeva SiteVault(Site)
Florence eBinders(Site)
Box(Storage)

Ready for Your Next FDA Inspection?

Join clinical research organizations achieving 90%+ eTMF completeness scores

Ready to Transform Your Document Operations?

Join enterprise leaders already revolutionizing their document management, compliance, and business processes with AI.

Free waitlist with early access
Priority access available (refundable)
Dedicated onboarding support
60-day money-back guarantee