eISF & eTMF

Unify your trial documents. Achieve inspection readiness.

Eliminate email attachments, fragmented shared drives, and manual reconciliation. Clincove seamlessly syncs site and sponsor master files in one continuously compliant ecosystem.

Join 50+ forward-thinking clinical teams

Powering trials across leading research organizations

Lilly
Sanofi
AstraZeneca
Biogen
Zurabio
Olema Oncology
Median QC Time 0
Total TMF Docs 0
Documents by Status
12
Placeholder
18
Draft
22
In Review
14
QC
8
QC Failed
32
Approved
Incomplete 30
Placeholder 12
Draft 18
In Review 44
In Review 22
QC 14
QC Failed 8
Approved 68
Docs Submitted by Site
Mountainview General Hospital 78 Docs
Evergreen Community Hospital 64 Docs
Pioneer Medical Center 50 Docs
Apex Care Institute 42 Docs
Starlight Medical Institute 35 Docs
Providence General Hospital 30 Docs
Holy Cross Health Institute 20 Docs
eTMF Sync

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
Have Questions?
Document Distribution

Push documents to any site ISF in seconds

Select documents from the Trial Master File, choose destination sites, and transfer everything in one click. No more emailing files or manually uploading to each site's binder.

  • Bulk transfer to multiple sites
  • Full audit trail on every push
  • Version-controlled delivery
  • Automatic site acknowledgment tracking
Have Questions?
Trial Master File
Transfer
0 files 0 sites
Search TMF Documents
Type keyword or document name...
Recruitment Plan.pdf 2025-05-12
Monitoring Plan.pdf 2025-05-12
Safety Management Plan.pdf 2025-05-12
Communication Plan.pdf 2025-05-12
Data Management Plan.pdf 2025-05-12

Add files to the transfer queue

Search documents from the TMF or upload to get started.

Destination Sites
Site Selector
Choose Site ISF
+ Select all sites
+ Crescent Bay Hospital
+ Pioneer Medical Center
+ Summit Valley Healthcare
+ Starlight Medical Institute
+ Riverside Specialty Clinic
Selected Sites
Crescent Bay Hospital
Pioneer Medical Center
Summit Valley Healthcare

Choose destination sites here

Selected documents from the left column will be sent to the selected sites here.

Transferring documents... Pushing 3 documents to 3 sites
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Redaction Mode
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Initial Visit Screening

Draft 01.01.03
... 01. Trial Management 01.01 Trial Oversight
DOCX v1.0
Details
History
AI Insights
Document Management
Overview Metadata Comments Redaction
Document is expiring within 90 days

The Principal Investigator's medical license will expire on March 31, 2023. To prevent compliance issues and ensure the site remains audit-ready, a renewed version must be on file.

Owner John Anderson
Assigned to
Scarlett Wyatt
5 Linked Tasks
Tasks Status Due Date Assigned to
Schedule Appointments with Patients Not Started June 6, 2024 JAB
Track Progress with Studies In Progress June 7, 2024 JAB
Analyze Data with Graphs Draft June 8, 2024 JA
Monitor Compliance with Alerts Cancelled June 9, 2024
Manage Access with User Roles Completed June 9, 2024 B
S Scarlett Wyatt 1 hour ago

Lorem ipsum dolor sit amet, consectetur adipiscing elit.

J Justin Beaver 1 hour ago

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Integer nec odio praesent libero.

S Sofia Turner 1 hour ago

Sed nisi. Nulla quis sem at nibh elementum imperdiet. Duis sagittis ipsum.

L Liz Javier 1 hour ago

Praesent mauris. Fusce nec tellus sed augue semper porta.

L Liz Javier 1 hour ago

Praesent mauris. Fusce nec tellus sed augue semper porta.

Add a reply
E Emily Burton 2 hours ago

Lorem ipsum dolor sit amet, consectetur adipiscing elit.

5 replies
J A B C D
E Emily Burton 2 hours ago

Lorem ipsum dolor sit amet, consectetur adipiscing elit.

Add a comment

Page 1

1
(x: 72, y: 550, width: 250, height: 20)
Timeline Versions Audit Trail
Jul 25, 2025 John Anderson changed status from Placeholder to Draft
Jul 24, 2025 John Anderson changed status from Draft to Placeholder
Jul 23, 2025 John Anderson changed status from Draft to Submitted
Jul 22, 2025 John Anderson changed status from Submitted to Reviewed
Jul 21, 2025 John Anderson changed status from Reviewed to Attention
Jul 20, 2025 John Anderson withdrew Initial Visit Screening v1.0
Jul 19, 2025 John Anderson changed status from to Finalized
Jul 18, 2025 John Anderson added a new signature ~~~
Jul 17, 2025 John Anderson uploaded a new version v15.0
Jul 16, 2025 John Anderson changed status from Placeholder to Draft
Jul 15, 2025 John Anderson added a new signature ~~~
Jul 14, 2025 John Anderson changed status from Draft to Placeholder
Version Date Changes
v15.0Jun 19, 2025Lorem ipsum dolor sit amet, consectetur adipiscing...
v14.0Jun 18, 2025Lorem ipsum dolor sit amet, consectetur adipiscing...
v13.0Jun 17, 2025Lorem ipsum dolor sit amet, consectetur adipiscing...
v12.0Jun 16, 2025Lorem ipsum dolor sit amet, consectetur adipiscing...
v11.0Jun 15, 2025Lorem ipsum dolor sit amet, consectetur adipiscing...
v10.0Jun 14, 2025Lorem ipsum dolor sit amet, consectetur adipiscing...
v9.0Jun 13, 2025Lorem ipsum dolor sit amet, consectetur adipiscing...
v9.5Jun 12, 2025Lorem ipsum dolor sit amet, consectetur adipiscing...
v8.0Jun 11, 2025Lorem ipsum dolor sit amet, consectetur adipiscing...
v8.5Jun 10, 2025Lorem ipsum dolor sit amet, consectetur adipiscing...
v7.0Jun 9, 2025Lorem ipsum dolor sit amet, consectetur adipiscing...
v6.0Jun 8, 2025Lorem ipsum dolor sit amet, consectetur adipiscing...
Action User Name Date Description
READSofia MartinezFeb 6, 2025Lorem ipsum dolor sit amet
READLotus TullyFeb 6, 2025Consectetur adipiscing elit
READSofia MartinezFeb 6, 2025Phasellus hendrerit
READEmily BurtonFeb 6, 2025Justo eget volutpat
READMarissa CharlesFeb 5, 2025Mollis enim turpis
READJerry WaltersFeb 4, 2025Condimentum dui
READCraig SimpsonFeb 4, 2025Feugiat libero ante
UPDATEVera CarisonFeb 3, 2025Eget purus nulla
READGeorge SmithFeb 3, 2025Sed id justo
UPDATEVera CarisonFeb 3, 2025Velit bibendum aliquam
CREATEGeorge SmithFeb 3, 2025Integer id dolor non
READJerry WaltersFeb 3, 2025Sapien scelerisque
Doc Analysis Chatbot
CRF
Visit 1 — Screening Submitted
92%
47/52 Fields Complete
2 Queries Open
1 Risk Flag
3d 4h Cycle Time
Compliance Checks
Informed consent dated prior to any study procedures
All inclusion/exclusion criteria assessed and documented
Demographics & medical history sections complete
! Vital signs — systolic BP 148 mmHg exceeds protocol threshold (140)
× Lab results — HbA1c value missing, required for eligibility
Field Completion
Demographics
100%
Medical History
100%
Vital Signs
83%
Lab Results
60%
Eligibility
100%
Suggested Actions
High Open query for missing HbA1c — required for eligibility determination per Protocol §4.2
Med Flag elevated BP reading for PI review — may affect randomization eligibility
Low Confirm concomitant medication list is complete before Visit 2 scheduling

Document AI

Ask anything about Visit 1 — Screening CRF

What fields are missing? Is this subject eligible? Summarize vital signs Compare to protocol criteria List open queries
Ask Anything...
Workflow Signatures

Artifact Status Flow

PlaceholderSiteUserDraftSiteUserSiteUserCRAReviewedSiteUserFinalizedCRAAttentionSiteUser
5 Lorem Ipsum
Date Time Signed by Signature Note
Jun 19, 202512:00 pmSofia MartinezSofia MartinezLorem ipsum dolor sit amet
Jun 18, 202501:00 pmLotus TullyLotus TullyPraesent facilisis nisi
Jun 17, 202502:00 pmSofia MartinezSofia MartinezNec sollicitudin risus
Jun 16, 202503:00 pmEmily BurtonEmily BurtonIn hac habitasse plati
Jun 15, 202504:15 pmMarissa CharlesMarissa CharlesDuis finibus erat
Jun 14, 202505:05 pmJerry WaltersJerry WaltersPraesent facilisis nisi
Jun 13, 202505:32 pmCraig SimpsonCraig SimpsonNec sollicitudin risus
Jun 12, 202506:20 pmVera CarisonVera CarisonIn hac habitasse plati
Jun 11, 202506:55 pmGeorge SmithGeorge SmithDuis finibus erat
Jun 10, 202507:00 pmVera CarisonVera CarisonPraesent facilisis nisi
Jun 9, 202508:40 pmGeorge SmithGeorge SmithNec sollicitudin risus
Document Details

Every document at your fingertips, with full context

Open any document and instantly see its full lifecycle — ownership, linked tasks, AI-powered insights, and compliance status — right alongside the built-in PDF viewer. No tab-switching, no second system.

  • Built-in PDF viewer with annotations
  • Linked task management per document
  • Proactive expiration alerts
  • AI-powered document insights
Have Questions?
Under the Hood

Everything you need for flawless compliance

The practitioner-grade features that keep your Trial Master File inspection-ready at all times

Real-time Synchronization

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

Audit-Ready Compliance

Every document is automatically tagged, indexed, and stored according to TMF Reference Model standards. Generate inspector-ready views in minutes.

Smart Classification

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

21 CFR Part 11 eSignatures

Built-in compliant electronic signatures with identity verification and complete signature audit trail. Full FDA compliance out of the box.

Email-to-ISF Ingestion

Forward sponsor emails directly into the eBinder. Attachments are auto-extracted, classified, and filed with chain-of-custody preserved.

Built-in PDF Viewer

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

Compare

Stop paying the legacy tax

See why top sponsors are migrating to Clincove to unify their trial documents and eliminate manual reconciliation

FeatureLegacy eTMFsClincove
Document SyncManual uploads & emailNative, real-time sync
Site ExperienceSeparate login requiredUnified with EDC & eSource
Document ClassificationManual taggingAI-powered auto-classification
Inspection ReadinessWeeks of preparationAlways inspection-ready
TMF ReconciliationPeriodic manual auditsContinuous, automated
PricingPer document / per GBPredictable, transparent pricing

Have Questions?

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