A trial master file that is always inspection-ready.
EClinCloud eTMF manages trial documents across their full lifecycle — collection, storage, retrieval, sharing, and tracking — in line with GCP and FDA 21 CFR Part 11.
Filed right the first time
AI reads document content, study, site, and TMF Index context to suggest classification and filing location — fewer misfiles and less manual judgment.
Quality checked upstream
AI QC flags duplicates, blank pages, watermarks, and blurred content at upload, shifting quality control forward and cutting rework.
Ready for inspection
Managers see TMF completeness, timeliness, and quality in real time, and inspectors get a straightforward path through audit and review.
How it works
Capture at the site
Scan documents with the ECC ONE mobile app — automatic recognition, image correction, and quality checks lower the cost of on-site collection.
Classify with AI
AI reads content, study, site, document type, and TMF Index context to suggest the right category and filing location.
QC before filing
Duplicates, blank pages, watermarks, and blurred content are caught automatically before they enter the TMF.
Confirm and file
After human confirmation, documents are filed by site, participant, and visit — viewable online and shareable across the team.
Monitor and inspect
Completeness, timeliness, and quality status stay visible in real time, with search and tracking that stand up to audits.
Core capabilities
Document capture
- Smart scanning with the ECC ONE mobile app
- Automatic image recognition and correction
- Assisted quality checks before upload
Filing & retrieval
- TMF Index-based classification and filing
- Organized by site, participant, and visit
- Centralized upload with online viewing, search, and sharing
Compliance & quality
- Aligned with GCP and FDA 21 CFR Part 11
- Real-time visibility into completeness, timeliness, and quality
- Accuracy, integrity, security, and traceability by design
- A straightforward experience for audits and inspections
Migration & advisory
- TMF data migration services
- TMF management framework design
- Global TMF compliance consulting
- One-on-one role-based training
AI where it helps
Smart mobile scanning
Documents scanned via the ECC ONE app are auto-recognized, corrected, and quality-checked — lower collection cost at the site, higher quality at upload.
AI classification & filing
AI uses content, study, site, document type, and TMF Index signals to suggest the right category and filing location, cutting misfiles and manual triage.
AI-powered QC
Duplicates, blanks, watermarks, and blur are flagged automatically, moving quality control upstream and reducing missing or non-conforming files.
LinBot AI assistant
A role-aware assistant that answers system, workflow, and how-to questions around the clock, in multiple languages.
Connected by design
Services & implementation
Study build, migration, training and managed operations come from the same team — implementing and supporting eTMF never needs another vendor. See services →