oomnia eTMF

oomnia eTMF is an electronic Trial Master File software developed by Wemedoo, designed to manage clinical trial documentation from study startup through to final archival. It is intended for sponsors, clinical research organizations (CROs), and trial sites that need to store, organize, track, and retrieve study documents in a compliant and auditable manner.

The platform is built to meet multiple regulatory and data privacy standards, including 21 CFR Part 11, HIPAA, GDPR, ICH GCP, Swiss Data Privacy Law, and FAIR ALCOA+. It also aligns with GCP, EMA, and ICH guidelines, supports the CDISC TMF reference model, and accommodates alternative standards such as ISO 14155:2020.

Document Management

• Stores and organizes clinical research documents including study protocols, informed consent forms, ethics committee approvals, monitor reports, safety reports, and data management plans.
• All documents are held in a standardized, catalogued system that allows users to locate and view documents and their versions quickly.
• Supports upload of any electronic document type; pre-created placeholders provide a structured framework to reduce upload errors.
• Automated document indexing, categorization, and tagging help organize the document repository.
• Advanced search and filter functions allow users to sort and display documents based on specific criteria.
• The eTMF can be locked after archival and unlocked if additional imports or corrections are required by the sponsor, then re-locked once corrections are complete.

Inspection Readiness and Audit Support

• Real-time dashboards display eTMF completeness metrics, including expected and missing documents, providing oversight of inspection readiness at all trial stages.
• Real-time integrated eTMF reports support compliance by enabling comprehensive oversight of TMF progress, quality, and completeness.
• Standardized filing and indexing follow the TMF reference model, ensuring consistency and ease of retrieval during audits and regulatory inspections.
• Supports three export formats — CSV, XLSX, and XML — for all documents, facilitating data handling and report generation.
• Quick and easy access to relevant study documents is provided to facilitate reviews by regulatory authorities.

Access Control and Data Security

• Role-based access control assigns user-specific permissions so that only authorized personnel can access sensitive information.
• Data is encrypted both in transit and at rest to protect against unauthorized access and data breaches.
• Two-factor authentication adds an additional layer of security for system access.
• Continuous monitoring and regular cybersecurity audits are conducted to verify adherence to industry security standards and regulatory requirements.

Version Control and Change Tracking

• Provides version control and change tracking for all documents, maintaining document integrity over time.
• A detailed audit trail records all changes in the eTMF system, including modifications to the eTMF structure and individual documents or placeholders.
• Automated versioning of uploaded documents is included, with preview and approval available at the document version level.
• Document version transparency ensures accessibility and traceability of all changes.
• Query functionalities allow users to communicate and highlight document discrepancies, address missing information, and resolve documentation issues.
• Real-time monitoring tracks document uploads, approvals, quality checks, and overall eTMF completion status.

Regulatory Compliance Features

• Supports proper documentation and archiving of study documents in line with GCP standards.
• Adheres to GDPR, Swiss Data Privacy Law, and HIPAA for trial data privacy and security.
• Flexible design accommodates both CDISC TMF reference model standards and alternative guidelines such as ISO 14155:2020.
• Real-time reports enable comprehensive document management and oversight to meet regulatory requirements.

Complementary Services

• Wemedoo offers professional services alongside the software, including eTMF setup and administration, biostatistics and statistical programming, and medical writing and documentation.
• These services are designed to support teams with optimal eTMF configuration and ongoing administration throughout the trial lifecycle.

oomnia eTMF is part of the broader oomnia platform, a unified SaaS clinical trial ecosystem that also includes EDC, RTSM, CTMS, eSource, ePRO, eCOA, and eConsent modules, all operating on a single instance. The platform supports multiple trials simultaneously and allows organizations to select and customize the modules relevant to their workflows. Wemedoo is based in Switzerland and operates under Swiss data privacy standards.