Built for
Audit readiness
diCELLa eTMF
Audit-ready document control
Keep your trial master file inspection-ready without managing the chaos around it.
diCELLa eTMF gives enterprise clinical teams a cleaner way to manage study documentation with centralized control, integrated workflows, and compliance-oriented visibility across the wider platform, including connected eCRF and CTMS-ready operations.
Connected to
eCRF + CTMS
Designed for
Enterprise teams
eTMF command view
One operating surface for completeness, control, and inspection preparedness.
Completeness overview
98.6%
Expected artifacts
1,248
Pending review
34
Expiry alerts
7 flagged
Audit trail activity
Live
Every change, review, and document state transition tracked in context.
Access model
Role-based
Controls aligned to sponsor, CRO, site, and study responsibilities.
Integrated visibility
eTMF
eCRF
CTMS
Alerts
The problem
Fragmented document processes create avoidable risk long before an audit begins.
Enterprise clinical teams do not struggle because the work is unimportant. They struggle because documentation is too often spread across disconnected tools, manual trackers, and inconsistent ownership models.
Scattered documentation
Files sit across inboxes, shared drives, portals, and isolated study tools.
Audit stress
Inspection preparation becomes a scramble instead of a stable operating habit.
Missing files
Gaps surface too late because expected artifacts are not visible in one place.
Manual tracking
Teams spend time chasing spreadsheets and reminders instead of moving studies forward.
Disconnected systems
Documents, operations, and study context drift apart across multiple platforms.
The solution
A centralized eTMF solution connected to the wider diCELLa clinical trial platform.
diCELLa eTMF gives teams one place to control documentation, maintain a durable audit trail, track expiry-sensitive documents, and keep document operations connected to broader study execution.
Centralized document management
Bring filing, oversight, and completeness visibility into one controlled environment.
Durable audit trail
Track document activity and lifecycle changes in a way that supports inspection confidence.
Document expiry tracking
Catch renewals and expiring study-critical records before they become operational issues.
Role-based access
Control who can view, manage, and act on documents across stakeholders and study roles.
Integrated with eCRF and CTMS
Keep document readiness aligned with operational study context instead of maintaining separate realities across separate tools.
eTMF gallery
See the platform interface in context.
Browse product screens as compact previews, then open any image to inspect the interface in a focused viewer.
Login area
Main dashboard
Study dashboard
eTMF structure
eTMF file details
Key benefits
Built to help enterprise buyers reduce risk without adding administrative burden.
The eTMF value proposition is practical: stay ready, reduce overhead, and keep documentation aligned with how studies actually operate.
Stay audit-ready
Always closer
Make readiness a continuous operating state instead of an event-driven scramble.
Reduce admin overhead
Less chase
Spend less time managing trackers, reminders, and scattered ownership across disconnected systems.
Improve inspection preparedness
More confidence
Keep the file structured, traceable, and easier to defend under sponsor or regulator scrutiny.
Unify study documentation
One system
Connect documents, workflows, and broader study operations inside one platform model.
Feature grid
Enterprise-grade features for document control, visibility, and trust.
The platform is designed to support day-to-day execution as well as the compliance posture enterprise clinical teams need to maintain.
eTMF / eISF
eTMF / eISF support
Manage sponsor and site-facing document structures with cleaner oversight across the study lifecycle.
Workflow
SOP and agreement workflows
Handle controlled documentation processes in the same environment as broader study operations.
Alerts
Expiry alerts
Stay ahead of expiring agreements, licenses, and study-critical document deadlines.
Visibility
Integrated document visibility
See documentation status alongside operational context from eCRF and CTMS rather than in isolation.
Permissions
Role permissions
Support enterprise access models with permissions aligned to study roles and responsibilities.
History
Activity history
Maintain a clear record of changes, reviews, and actions across the document lifecycle.
Compliance and trust
Positioned for regulated environments where document discipline matters.
diCELLa eTMF is designed to support the expectations enterprise trial teams bring to audit readiness, controlled access, and inspection-oriented operational workflows.
Inspection-oriented workflows
Help teams maintain structure and control in a way that supports sponsor and regulator expectations.
Audit trail visibility
Make document history easier to review, trace, and defend during oversight moments.
Controlled access
Use role-based permissions to support better governance across sponsors, CROs, and study stakeholders.
Enterprise trust posture
Align the product story with the compliance, quality, and implementation maturity large buyers expect.