Master Your Trial Documentation with oomnia eTMF

Assigning user-specific access permissions based on roles ensures only authorized personnel access sensitive information. This approach safeguards sensitive information by restricting access to those with appropriate roles and responsibilities.

Encryption of data both in transit and at rest protects against unauthorized access and data breaches. The security measure of encryption safeguards data during transfer and storage.

Enhanced security results from the use of additional authentication methods for system access. The incorporation of extra authentication steps contributes to improved security.

Continuous monitoring and regular cyber security audits are conducted to ensure adherence to industry security standards and regulatory requirements. These practices verify compliance with security standards and regulations in the cyber security field.

All documentation and trial conducts align with Good Clinical Practice (GCP), European Medicines Agency (EMA) and International Council for Harmonisation (ICH) guidelines.

Adherence to GDPR, Swiss Data Privacy Law, and HIPAA ensures trial data privacy and security.

The flexible design of oomnia eTMF accommodates both CDISC standards and alternative guidelines like ISO 14155:2020.

Real-time integrated eTMF reports ensure compliance with regulatory requirements by enabling comprehensive document management and oversight of TMF progress, quality, and completeness.

Any document type in electronic format can be uploaded to the system. Pre-created placeholders provide users with a clear framework, reducing the likelihood of errors when uploading documents.

The organization of documents can be optimized through automated indexing, categorization, and tagging.

An advanced filter functionality ensures that the system shows relevant content depending on criteria entered by the user. This allows users to sort and categorize the display of documents based on specific criteria.

oomnia eTMF supports three types of exports: CSV, XLSX, and XML export of all documents, facilitating efficient data handling and report generation.

oomnia eTMF adheres to TMF reference model for document filing and indexing, ensuring consistency and ease of retrieval during audits and inspections.

Queries functionalities to communicate and highlight document discrepancies are included. oomnia eTMF addresses missing information or needs for documentation clarification, enhances document accuracy and integrity, and streamlines communication and resolution of documentation issues.

oomnia eTMF ensures a comprehensive management of document progress and status, real-time insights on document uploads, approvals, and quality checks. Real-time monitoring with eTMF reports is included for tracking eTMF completion.

A detailed recording of all changes in the eTMF system is possible, providing a full audit trail. Another feature is the tracking of modifications to eTMF structure and specific documents or placeholders. oomnia eTMF maintains document version transparency, ensuring accessibility and traceability of changes.

oomnia eTMF offers a detailed audit trail and documents any structural or document change. This also includes automated versioning of uploaded documents. Preview and approval are provided at the document version level.