OKILYS suite · Trial Master File
OKILYS eTMF, the TMF that fills itself during the study, not after
An electronic Trial Master File structured per the TMF Reference Model, connected to OKILYS CTMS: the documents produced during the study are filed automatically as drafts in the right section, your teams verify them, and completeness is read continuously — instead of the painful end-of-study reconstruction.
OKILYS eTMF exists today as a module of OKILYS CTMS; the dedicated site etmf.okilys.com is in preparation — tell us about your needs now, they will shape the tool.
What OKILYS eTMF does
Automatic filings
Documents collected on sites, study document versions, regulatory and ethics submissions, contracts, greenlight checklists and signed visit reports: every item produced in the CTMS lands as a draft in the right section of the TMF, at the right level (trial, country, site).
Human verification
Nothing is filed as final on its own: the country CRA or the project manager is notified, verifies each filing and validates it — or rejects it. Manual filings complete the file.
Continuous completeness
Expected artefacts configured per study, completeness measured per zone, per country and per site: you know at any time what is missing, without waiting for the audit.
Connected ISF/PSF review
From the monitoring visits, the CRA ticks what was reviewed in the investigator site file, with automatic cross-check against the eTMF, and uploads the collected documents — filed directly as drafts.
Aligned with industry conventions
Zones / sections / artefacts structure of the TMF Reference Model, Trial / Country / Site levels, ICH E6(R3) requirements. Draft / Final / Superseded statuses, traced versions.
Complete hand-back
Indexed ZIP export (folders per zone, section, artefact and level + CSV index): the TMF is handed to the sponsor or the auditor in one move, during the study as well as at close-out.
Designed with OKILYS CTMS, from day one
OKILYS eTMF is the natural extension of OKILYS CTMS: because the CTMS already traces visits, signed reports, submissions and site documents, the TMF can build itself without double entry. It is offered today as a CTMS module and will then be a dedicated site.