Clindex eTMF
Centralize, organize, review, and maintain essential study documents within a secure eTMF designed for clinical research.
Real-time oversight
Site status, always current
Audit-ready
Compliant by default
No double entry
One record across modules
eTMF capabilities
Clindex eTMF provides the capabilities required to organize, collect, review, track, and maintain essential study documentation within a secure and configurable system.
TMF structure
Organize documents using a standardized or customized filing structure.
Document collection
Collect essential documents from study teams, sites, and external partners.
Review and approval
Document goes into queue for review and approval.
Workflows
Add workflows for document types to track training, read and acknowledge, and more.
Version control
Ensure teams work with the correct document version and preserve history.
Completeness tracking
Identify missing, expected, overdue, or incomplete documents by study, country, site, or type.
Quality control
Support reviews and quality checks with defined statuses and audit trails.
Role-based access
Provide appropriate access based on study role, organization, or document type.
Audit trail
Maintain a complete history of all document activity and actions.
Continuous readiness
Inspection readiness should not begin when an audit is announced. Clindex eTMF helps teams identify gaps, monitor document status, and address issues throughout the study instead of waiting until closeout.
Collect
File
Review
Approve
Monitor
A more controlled eTMF experience
Clear document requirements
Automatically flag expired documents
Complete version and activity history
Consistent review workflows
Greater inspection confidence
Earlier identification of missing documents
TMF dashboards
Clindex eTMF dashboards give study teams a clear view of document completeness, quality, review status, and outstanding work so they can focus attention where it's needed most.
46 open items
Form FDA 1572
Site 1004 · Regulatory · 12d overdue
Financial disclosure form
Site 1002 · Regulatory · 5d overdue
Delegation of authority log
Site 1003 · Site Mgmt · Awaiting review
IRB approval letter
Site 1001 · Regulatory · Expires in 9d
Monitoring visit report
Site 1004 · Clinical · Missing
1,248
Filed 1,151 (92%)
Pending review 15 (1%)
Overdue 7 (1%)
Missing 24 (2%)
% Complete
Site 1001
98%
Site 1002
95%
Site 1003
90%
Site 1004
85%
Sponsor eTMF and site eISF
Clindex includes a fully integrated eISF, so documents are filed once and both the site and the sponsor can see them immediately. No duplicate uploads, no separate portals, no reconciliation.
Oversight and inspection readiness
Real-time completeness across the study and each site
Review and approval workflows with full audit trail
Missing, expiring, and overdue documents flagged automatically
Inspection-ready structure with no end-of-study scramble
Clindex
One record
Filed once. Visible by both sides.
Site-controlled, always current
Sites upload once, no email, no shared drives
Site staff keep their own regulatory binder, digitally
Access controlled by role
Training, read-and-acknowledge, and signatures captured in place
No duplicate filing
A document filed at the site is the same record the sponsor sees, no re-upload, no version drift.
No reconciliation
eTMF and eISF stay aligned by design, so there is nothing to reconcile before a lock or an audit.
Faster start-up
Start-up packets move through the site and back to the sponsor without chasing attachments.
Site-friendly
One login, a familiar binder structure, and no separate portal for site staff to learn.
Integrated platform
Clindex eTMF can operate as a standalone document management system or in conjunction with the Clindex fully integrated eClinical solution. When used together, study, site, user, and milestone information supports more coordinated document workflows and oversight.
Clindex
Integrated by design
EDC
eTMF
CTMS
eCOA / ePRO
Reporting
Site feasibility
Reduce duplicate study setup
Improve coordination across teams
Align documents with study milestones
Maintain consistent site and study data
Improve visibility across operations
Why Clindex eTMF
Built for TMF management, inside the same platform as your study.
Nearly 30 years
Supporting clinical research
Global reach
Trusted by organizations worldwide
FDA-Regulated
Successfully supporting FDA-regulated studies
Built to scale
From single-site studies to global programs
Trusted by organizations managing TMFs worldwide
Built for sponsors, CROs, and sites across the eTMF ecosystem
Supports documents across the full study lifecycle, from startup through closeout
Scales from single-site studies to global multicenter programs
Share templates across studies, no rebuild per protocol
Successfully supports FDA-regulated clinical studies
Configurable without custom software development
Backed by a dedicated team that partners closely with every customer
Inspection readiness demands technology that is dependable, structured, and proven in real-world studies. Clindex eTMF delivers a single system backed by decades of experience supporting organizations around the world.
