CLININFO ETMF
Effortless Configuration

Standard or customized TMF configuration, ready and tailored in minutes

Smart Document Upload

From one file to a full batch, intuitive upload and relocation process.

Operational TMF Control

Clear overview and day-to-day management of TMF content and quality.

Export & Interoperability

Easy and compliant TMF exports for portability and traceability.

Our aim

Help sponsors and CROs regain control of their Trial Master File, by making TMF configuration intuitive, fast, and fully adaptable - so you can focus on what truly matters:
delivering your study efficiently and compliantly.

Our offer

Pre-Configured CDISC TMF Model

Launch a fully compliant TMF with a single click -no setup hassle, just instant readiness.

Customizable for Every Sponsor or CRO

Tailor the TMF structure to your specific needs, and reuse it effortlessly for future projects.

Autonomous Study Adaptation

TMF can be adjusted to study requirements without waiting for IT or external support.

Seamless Intercurrent Changes

Changes implemented in real time, keeping the TMF always accurate and up-to-date.

Flexible Document Access Control

Control of who can view or upload each document, ensuring secured accesses.

Advanced Version Management

Document-specific versioning strategy: single version, parallel versions, or sequential tracking.

Our aim

Eliminate friction in your document management process by making uploads fast, secure, and error-proof, we empower teams to maintain a complete, compliant TMF without wasting time on repetitive or risky tasks.

Our offer

Single or Batch Uploads

Drag and drop individual files or entire batches - speed up your workflow without hassle.

Built-In File Control

All common file types accepted, with built-in virus protection.

One-Click Assignment

Instantly assign files to the right study, country, or site, avoiding misplacement and confusion.

Granular Upload Permissions

Control who can add documents, ensuring security while keeping collaboration smooth.

Integrated Version Management

Document version automatically tracked, with pre-completed version number.

Easy Correction & Re-Location

Misplaced files can be moved or edited effortlessly, keeping the TMF clean and organized.

Our aim

Ensure that TMF management remains organized, transparent, and fully controlled with simplified processes, so that operational efficiency is maximized across studies.

Our offer

Intuitive TMF Tree View

TMF displayed in a clear, tree-structured layout, with filters applied to quickly locate documents.

Documents Viewed Online

Files are opened directly in the browser, eliminating the need for local downloads.

Configurable Quality Control with Queries

Manual quality control with queries posted, until documents are corrected or uploaded again.

Incorrect Documents Control

Documents can be deleted temporarily or permanently, with restoration available.

TMF Milestones

Configurable milestones associated to each document, ensuring timelines are clearly defined.

Missing Documents Tracking

Missing documents identified in a simple, exportable list, enabling simple monitoring.

Our aim

Ensure that TMF data remains accessible, transferable, and compliant throughout the study lifecycle with structured, auditable, and interoperable exports, enabling smooth collaboration with external partners and regulatory stakeholders.

Our offer

Easy TMF Export

Complete TMF exported in just a few clicks, with a structured and ready-to-use output.

Country-Level TMF Export

Export per country to meet regulatory requirements or support collaboration with local CROs.

Site-Level TMF Export

Export available by site, allowing sites to retrieve their own documentation when required.

Embedded Audit Trail

Complete audit trail embedded in the export, ensuring full traceability of all document actions.

Smart Version Selection

Exports can be configured to include only the latest version or the full history of each document.

TMF Exchange Mechanism Standard

TMF Exchange Mechanism standard to enable seamless interoperability with other systems.

Efficient TMF Operations

Tools designed to simplify workflows and adapt to real-world needs.

Operational Simplicity

Fast, clear TMF operations designed to reduce effort and save time at every step

Our aim
Remove unnecessary friction from TMF operations by prioritizing clarity, speed, and ease of use, day-to-day activities are accelerated and teams can work efficiently without struggling with complex interfaces or processes.
Key Capabilities
  • Intuitive TMF exploration, without complex or overloaded interfaces.
  • Documents uploaded in batches and assigned later, keeping operations moving without interruption.
  • Missing documents are highlighted in a clear and easy-to-read list.
  • TMF exports include a structured inventory to quickly locate any document.

Tailored by Design

A TMF structure that adapts to organizations, studies, and working habits

Our aim
Provide a TMF that fits real-world practices, by enabling deep yet simple customization, processes are aligned with internal standards, local terminology, and operational needs - without adding complexity.
Key Capabilities
  • TMF models fully customizable and easily reused across sponsors, CROs, or studies.
  • Alternative document names defined to support different terminologies and improve usability.
  • Upload and download permissions are configured per role to match organizational rules.
  • Custom reports and exports can be generated to meet specific operational or regulatory needs.

Built for Interoperability

A standardized TMF designed to connect smoothly with external systems.

Our aim
Ensure seamless TMF exchanges across studies, partners, and platforms by relying on recognized standards and strict controls, data remains consistent, traceable, and ready to move whenever required.
Key Capabilities
  • Default CDISC-based TMF model provided and reused consistently across studies.
  • TMF exports comply with the TMF Exchange Mechanism standard to support interoperability.
  • Document formats and versions strictly controlled to ensure consistency and reliability.
  • All actions are fully traceable, providing complete visibility and audit readiness.

Advanced eTMF Tools

Advanced capabilities designed to extend the eTMF beyond standard document management

Study-Specific Document Creation

Study-specific documents can be created directly within the TMF model to reflect real operational needs.

Document Acknowledgement Tracking

The review and acknowledgement of newly available documents can be tracked when required.

Customizable Email Notifications

Email notifications can be configured for document uploads, summaries, or key TMF events.

Integration in EDC

Selected TMF documents can be made available for download directly from the EDC.

Extended Document Exchange Platform

The eTMF can be used as a secure document exchange platform, even outside the TMF context.

Storage Usage Monitoring

Allocated disk space is monitored to anticipate abnormal growth and maintain control over storage usage.

Contact Us to Learn More!

Complete Clinical Software Ecosystem

A wide range of seamlessly connected solutions to cover every aspect of your clinical study.

eCRF

Rapidly deploy and customize your study data capture.

ePRO

Capture patient-reported outcomes efficiently and remotely.

IWRS

Simplify randomization and study drug management.

CDMS

Centralize and clean study data in real time.

eTMF

Manage essential documents securely and compliantly.

CTMS

Track study progress and monitoring easily.

Regulatory Compliance

Our solution ensures full regulatory compliance, with secure, auditable, and reliable clinical data management.

FDA GCP GDPR HIPAA
ISO HDS SOC

See Your Study Come to Life

Discuss with our experts about your study, test a custom sandbox, and see how our solution can be tailored to your needs.

Request a Demo