If you are a pharmaceutical company, CRO, academia, medical device manufacturer, or visionary aiming to advance medicine, Wemedoo oomnia is the perfect fit for your clinical trial needs.

The unified oomnia SaaS solution natively includes Electronic Data Capture (EDC), Randomization & Trial Supply Management (RTSM), Clinical Trial Management System (CTMS), Electronic Trial Master File (eTMF), Electronic Patient Reported Outcomes (ePRO), Electronic Clinical Outcome Assessment (eCOA), eConsent, and eSource and allows real-time access to data and analytics across all tools, systems, and organizations.

Get real-time oversight, highest data quality, and reach your goals faster than ever.

eTMF

STREAMLINE YOUR TRIAL DOCUMENTATION - As a tool of our unified software, oomnia eTMF ensures seamless data flow and consistency across all aspects of a trial. Moreover, it reduces the number of logins by your colleagues as it allows them to access the eTMF at the same time as EDC, RTSM, and CTMS. As one system, custom-integrated reports can pull real-time information and synthesize it from all modules.

oomnia electronic Trial Master File (eTMF) is an integral part of the unified oomnia clinical research software. Digitally capture, store, manage, approve, and share trial documentation with ease while remaining compliant with regulatory guidelines and requirements. Perform all tasks with one simple login while having access to all other crucial clinical trial management functions, such as EDC, RTSM, and CTMS. oomnia eTMF offers a high level of flexibility and adaptability in terms of tailoring its structure to meet the specific needs and preferences of clients.

oomnia very quickly customizes every form to trial-specific requirements, a process is that is 3-5 times faster than the competition.

Manage your Documents Efficiently and be Inspection-Ready at any Time.

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Advanced Features

• USER FRIENDLY DOCUMENT MANAGEMENT: Simplify document handling with oomnia eTMF's centralized storage, easy archiving, and real-time inspection readiness.
• RELIABLE ACCESS CONTROL AND SECURITY: Safeguard data integrity with oomnia eTMF's role-based access, robust encryption, two-factor authentication, and regular audits.
• REGULATORY COMPLIANCE: Maintain compliance with oomnia eTMF's adherence to GCP, EMA, ICH guidelines, data privacy measures, CDISC TMF compliance, and real-time reporting.
• EFFICIENT DOCUMENT ADMINISTRATION: Streamline document management with oomnia eTMF's digitized handling, simplified uploads, automated indexing, and advanced search functions.
• AUDIT AND INSPECTION READINESS: Prepare for reviews with oomnia eTMF's versatile export options, standardized filing, and quick access to documents.
• ENHANCED VERSIONING AND CHANGE TRACKING: Track changes with oomnia eTMF's version control, change tracking, integrated query resolution, and dynamic document management.

Benefits

• EXCEPTIONAL QUALITY: Ensure eTMF inspection-readiness with traceable changes, full audit trail, and real-time integrated graphical reports.
• ENHANCED FLEXIBILITY: Accelerate eTMF setup by 3-5 times and tailor eTMF structure and forms to your study specific needs.
• ERROR REDUCTION: Minimize errors and facilitate easy detection of missing documents with well-organized eTMF structure, pre-created placeholders, and integrated reports.
• TIME SAVINGS: Reuse eTMF index and structure and roles and permissions from previous studies to reduce setup and training time.
• COST SAVINGS: Save costs by running multiple trials on a single instance and reusing the eTMF structure, incurring only the license and hosting fees.

Integrated Solutions

oomnia’s unified system supports multiple trials on a single instance, offering:

• Unified SaaS-solution
• Real-time Analytics
• Full Interoperability
• Unmatched User Experience

Compliance With

• ICH GCP E6
• Good Clinical Data Management Practices, edition 4 (GCDMP)
• Good Automated Manufacturing Practice, edition 5 (GAMP 5)
• FDA 21 CFR Part 820
• FDA 21 CFR Part 11
• Declaration of Helsinki
• ISO 9001:2015 standard
• ISO 27001:2022 standard
• EudraLex, vol. 2 and 4
• GDPR, FADP, and HIPAA

The next step in advancing your clinical research is with us.