ELECTRONIC TRIAL MASTER FILE

EvidentIQ eTMF supports better project management through real-time access to study documentation.
INTUITIVE WEB-BASED INTERFACE

ESSENTIAL DOCUMENT COLLECTION MADE EASY

EvidentIQ’s eTMF supports better project management through real-time access to study documentation. It offers clear workflows, reporting, search and retrieval, audit-readiness at each point in time, and many other valuable features. It is a cloud-based, highly configurable eTMF system with quality-focused workflows.

FEATURES

FULL AUDIT TRAIL AND VERSIONING

Focus on the Clinical Trial Process

Enjoy full audit trail and versioning, Metadata recording, Search and retrieval for audit readiness e-approval submission workflow. The software incorporates fine-grained role-based access and ensures your TMF to stay inspection ready.
MANAGEMENT OF TIMELINES, QUALITY AND COMPLETENESS

Improve filing efficiency and reduce laborious paperwork

  • Store and track multiple versions of your documents, as well as keep them clean for all eyes by redacting sensitive information, and linking issues/action items to a specific document version.
  • Create workflows for the review and/or approval of documents, as necessary.
  • Develop your own custom reports based on the document metadata
AUTOMATICALLY CREATE PLACEHOLDERS FOR DOCUMENTS

Plotting Your Course from filing to inspection readiness

Monitoring visits:

  • Pre-Visit letter, post visit letter and monitoring report, will automatically appear when a monitoring visit is added to the CTMS system.

Site Personnel:

  • When a new site personnel is added to the CTMS, a pre-defined set of document placeholders are added to the eTMF

BENEFITS

Plotting Your Course From Filing to Inspection Readiness

EvidentIQ’s eTMF leverages digital placeholder (PHs) to automatically generate the folder structure according to a predefined file plan. A file plan specifies the expected documents in each filing area and allows for up-to-the moment accuracy on the compliance documentation status. Notifications for overdue files keep everybody in sync.

Compliance with FDA and EMA Regulations

EvidentIQ’s eTMF contains all components, controls and policies that are required according to 21 CFR Part 11, ICH- GCP E6 and GDPR (General Data Protection Regulation). The system is specified and validated according to the regulatory and data protection requirements.

Fine-grained Role Based Controlled Access

Accommodate Site, Sponsor, CRO, External Users, Inspectors and auditors within one environment. Designate certain users as QC reviewers, to finalize documents as TMF-ready. The content is maintained in a secure, compliant environment with controlled access, configurable user roles, and a complete audit trail providing direct eTMF access for all study stakeholders.

Secured Anytime, Anywhere 24/7 Access

Our eTMF is a user-friendly application that can be accessed using a modern browser such as Edge, Chrome, Firefox and Safari. It offers easy and secured access for viewing, sharing, and retrieving any file from anywhere, anytime with customizable access levels.

Real-Time Dashboards

Get quick oversight into Quality, completeness and Timeliness. Dashboards display your study health, including overdue reporting, review status, new uploads and activity history.

Full support of your own TMF structure or the DIA Reference model

Trial master files are not one size fits all. EvidentIQ eTMF gives you the flexibility to use your own TMF structure, as well as natively supporting the DIA Reference model for identifying and classifying trial documents. Improve inspection readiness and system adherence to the TMF reference model.

“The team and I are looking forward to working with you on the integration of the EvidentIQ eTMF into your eClinical solutions as well as its future improvements.”

Manuel Neukum

Chief Operating Officer

RESOURCES

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