Electronic Trial Master File (eTMF)
Inspection-ready document management, every day of the trial.
A DIA Reference Model-aligned eTMF with automated filing, completeness dashboards and audit-grade version control. Documents flow in from CTMS, email and scanners — classified by AI and filed to the right zone, section and artifact automatically.
Capabilities
What Electronic Trial Master File (eTMF) does
DIA TMF Reference Model taxonomy with sponsor-specific extensions
AI auto-classification and metadata extraction on upload
Completeness and timeliness dashboards by country, site and zone
Controlled document workflows: draft, review, approve, supersede
Inspector view with read-only, timed access and download logs
Certified copy support and 21 CFR Part 11 e-signatures
Workflow
How teams run on it
Design
Model your protocol, visit schedule, CRFs and edit checks with versioned, CDISC-aligned study builders.
Capture
Collect site, patient and vendor data through EDC, ePRO/eCOA and API-driven external loads.
Clean & Review
Automated review rules, query management, SDV and medical coding keep data submission-ready continuously.
Analyze
Real-time dashboards, TFL generation and statistical compute bridges to SAS, R and Python.
Lock & Submit
Snapshot, e-signature sign-off, define.xml and submission package assembly with full traceability.
Benefits
Why enterprises choose Capacia
Faster time to value
Preconfigured templates, guided onboarding and migration tooling get teams productive in weeks, not quarters.
Lower total cost
One vendor, one contract, one integrated stack — retire point solutions and their integration tax.
Audit-ready always
Every action is logged, versioned and attributable. Evidence for auditors is a report, not a project.
Open by design
REST and GraphQL APIs, webhooks and event streams on every entity. Your data is never locked in.
Enterprise-grade security
SSO, RBAC, encryption in transit and at rest, and continuous security monitoring as standard.
Global scale
Multi-region deployment, 99.99% uptime SLA and 24×7 follow-the-sun support.
Electronic Trial Master File (eTMF) inherits the Capacia security baseline — encryption in transit and at rest, SSO with adaptive MFA, granular RBAC and immutable audit trails — plus the certifications and frameworks your regulators expect:
Industries served
Documentation
Full product documentation, API references and validation packages are available to customers and evaluators — request access.
FAQs
Frequently asked questions
How is Electronic Trial Master File (eTMF) deployed?
Electronic Trial Master File (eTMF) is available as managed SaaS in Capacia's cloud, in your own Azure / AWS / GCP tenancy, or on-premise for regulated environments. All deployment models receive the same release cadence and support SLAs.
Does Electronic Trial Master File (eTMF) integrate with our existing systems?
Yes. Every entity is exposed through documented REST and GraphQL APIs plus webhooks and event streams, and the Capacia Integration Hub ships 200+ prebuilt connectors for common enterprise systems.
What does implementation look like?
A typical rollout runs 4–12 weeks: discovery, configuration, data migration, validation and hypercare — led by a dedicated Capacia product team with a named success manager.
How is pricing structured?
Pricing is subscription-based, scaled to usage tiers within the Clinical Research Platform. Volume, multi-product and multi-year discounts are available — contact us for a tailored quote.
Is my data secure and compliant?
All products inherit Capacia's security baseline: encryption everywhere, SSO/MFA, granular RBAC, full audit trails, and compliance mappings for GDPR, HIPAA and — where applicable — 21 CFR Part 11 with validation documentation.
More from the Clinical Research Platform
See Electronic Trial Master File (eTMF) in action
A 30-minute demo tailored to your workflows — no slides, real product.