Discover how oomnia eTMF can make your clinical documentation process easier, faster, and fully compliant.
Why Choose oomnia eTMF?
Real-Time Inspection Readiness
Stay continuously prepared for audits with live tracking and instant document retrieval.
Simplified Document Management
Intuitive, user-friendly interfaces enable quick uploads, reviews, and approvals.
Enhanced Collaboration
Facilitate seamless communication among sponsors, sites, and CROs, ensuring everyone stays informed and aligned.
Robust Compliance
Built to adhere strictly to regulatory requirements, protecting your trial integrity and data security.
oomnia - Meeting Industry Standards
Our unified clinical trial software is designed with compliance at its
core, meeting critical industry standards. Our commitment to these
regulations ensures that your clinical trials are not only efficient but
also adhere to the highest levels of data integrity, privacy, and ethical
conduct.
21 CFR PART11
compliant
HIPAA
compliant
GDPR
compliant
ICH GCP
compliant
SWISS DATA PRIVACY LAW
compliant
FAIR ALCOA+
compliant
What oomnia Features do Our Clients Value the Most?
Simplify clinical document handling
oomnia eTMF stores and organizes all clinical research documents, such as the study protocol, informed consent forms, ethics committee approvals, monitor reports, safety reports, data management plans, and much more.
Centralized document storage
All documents are collected in a standardized catalogued system. The entire document array is visible, allowing for quick location and viewing of desired documents and their versions.
Document archiving and retrieval
If the eTMF structure is incomplete and an additional import or change of record is required from the sponsor, the eTMF can be unlocked. Once the requested correction is performed, the eTMF can be locked once again.
Real-time inspection readiness
Clinical trial real-time dashboards display eTMF completeness metrics, including both expected and missing documents. These dashboards offer critical insights and control over inspection readiness activities at all stages of the trial.
Safeguard your clinical data integrity
oomnia eTMF provides secure storage and access to study documents. Access to documents can be controlled based on user roles and permissions, ensuring confidentiality and integrity.
Role-based access control
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.
Data encryption
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.
Two-factor authentication
Enhanced security results from the use of additional authentication methods for system access. The incorporation of extra authentication steps contributes to improved security.
Regular security audits and compliance checks
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.
Maintain compliant with trial standards
oomnia eTMF helps to ensure compliance with regulatory requirements and Good Clinical Practice (GCP) standards by enabling proper documentation and archiving of study documents.
Adherence to GCP, EMA, and ICH guidelines
All documentation and trial conducts align with Good Clinical Practice (GCP), European Medicines Agency (EMA) and International Council for Harmonisation (ICH) guidelines.
Data privacy and security compliance
Adherence to GDPR, Swiss Data Privacy Law, and HIPAA ensures trial data privacy and security.
CDISC TMF reference model compliance
The flexible design of oomnia eTMF accommodates both CDISC standards and alternative guidelines like ISO 14155:2020.
Reporting
Real-time integrated eTMF reports ensure compliance with regulatory requirements by enabling comprehensive document management and oversight of TMF progress, quality, and completeness.
Streamline your trial’s document management process
By digitizing document management, oomnia eTMF enables faster, more efficient, and error-free handling of study documents compared to traditional paper-based TMFs.
Simplified file and data upload, approval, and storage
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.
Automated document indexing and categorization
The organization of documents can be optimized through automated indexing, categorization, and tagging.
Search and filter functions
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.
Prepare for every review and compliance check
oomnia eTMF facilitates audits and inspections by providing quick and easy access to relevant study documents. This is particularly important for reviews by regulatory authorities.
Versatile export options
oomnia eTMF supports three types of exports: CSV, XLSX, and XML export of all documents, facilitating efficient data handling and report generation.
Standardized filing and indexing
oomnia eTMF adheres to TMF reference model for document filing and indexing, ensuring consistency and ease of retrieval during audits and inspections.
Keep track of every change with precision and ease
oomnia eTMF provides version control and change tracking capabilities in documents, which is essential for maintaining document integrity over time.
Integrated query and discrepancy resolution
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.
Dynamic document management and reporting
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.
Real-time change tracking
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.
Automated version control and audit trails
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.
Switch to oomnia Now
Join us on your journey to advance clinical research together.
Our professional trial services complement your expertise. We support you with optimal eTMF setup and administration, statistical programming, and medical writing. We are ready to work hand in hand with your team, as needed.
Unlock More Possibilities
Elevate your clinical trial documentation management with our comprehensive suite of eTMF services. Designed to streamline the management of clinical trial documentation, ensuring compliance, efficiency, and collaboration throughout the trial lifecycle. Uncover the advantages of our eTMF Setup and Administration service.
Inspired by the Latin Word omnia, Meaning 'All Things',
We Created oomnia.
A single, unified system that brings together every part of a clinical
trial, from planning to global compliance.
EDC, RTSM, eTMF and CTMS, eSource, ePRO, eCOA and eConsent are
integrative parts of one and the same ecosystem supporting multiple
trials on a single instance.
Choose the modules and features that work for you and customize
everything to fit your workflow.
Streamlined Study & eCRF Implementation: Managed a complex study with 5000+ CRF questions and dynamic eCRF features that reduced manual queries by 66%.
Rapid Execution & Training: Completed design, implementation, UAT, and site training in just 9 weeks, ensuring a smooth go-live.
Accelerated Study Timelines: Achieved database lock within 2 weeks after the last patient’s visit, significantly speeding up the study.
Medical Device Real-World Evidence Study
Holistic Study Design: Integrated retrospective data collection and prospective ePRO arms, with expert protocol development.
Seamless Digital Integration: Leveraged oomnia EDC, eConsent, and ePRO to streamline data collection, consent, and patient engagement.
Automated Workflows & Unified Data: Implemented dynamic eCRF automation and real-time consent tracking with integrated data management for flawless protocol oversight.
Automated Oversight for a Phase IV Pediatric Study
Comprehensive & Real-Time PD Tracking: Developed a robust log capturing all protocol deviations in detail, with real-time reports by country, site, and participant.
Automated Role-Based Alerts: Implemented automatic email notifications that alert designated roles for timely review and approval.
Streamlined Data Entry & Resolution: Dynamic behaviors reduce redundant questions and dramatically cut the time needed to track, review, and resolve deviations.
FDA Inspection Passed Without Any Findings
Wemedoo ensures its validation procedures meet and surpass industry and regulatory standards. This underscores our commitment to software compliance, secure operations, and high-quality software.
Trusted Partners
Trusted by Global Clinical Research Teams
See What Our Clients Say
Read more about the experiences from those who have partnered with us
All jobs, both large and small, are performed with the same dedication to quality, detail, innovative thinking, and rigor. It is always a pleasure to work with the Wemedoo team.
Georg Mathis, PhD
CEO Appletree CI Group AG
Wemedoo embodies all the traits desired in a partner in the clinical trial industry – expertise, innovation, reliability, compliance, and attention to detail.
Martina Diminic Smetisko, DMD
Managing Director at Marti Farm Ltd
Their dedication to, and support of, our projects has resulted in clear quality deliverables. They are always there to answer any questions with expertise in a timely manner. I am...
Their dedication to, and support of, our projects has resulted in clear quality deliverables. They are always there to answer any questions with expertise in a timely manner. I am looking forward to our next project together.
Volodymyr Stus, MD
Biopharmaceutics and Clinical Research Department Manager at Polpharma SA
Wemedoo's cross-functional, integrated teams capture EDC set-up, go-live, data capture, data cleaning, and finally data analysis in a globally compliant fashion supporting trials in different geographies including the US. Their...
Wemedoo's cross-functional, integrated teams capture EDC set-up, go-live, data capture, data cleaning, and finally data analysis in a globally compliant fashion supporting trials in different geographies including the US. Their speed of addressing customer needs sets in my personal experience industry benchmark whilst keeping these data solutions lean and affordable. Besides the great proprietary systems they use, their integrated team approach with personal responsibility and honest commitment to targeting outcomes differentiates the Wemedoo team from other providers. Wemedoo only made Oxular's key initial trial, a device-drug trial possible, as based on some pre-work, the Wemedoo team could substantially adapt and update the first EDC ideas for a trial under a US FDA IND. The Wemedoo team worked extremely focused on familiarizing US trial sites and clinical CROs with the use of their system, which turned out to be a key success factor of the respective trial. The highly professional and up-to-date capabilities in data sciences were mirrored by customer-centricity and super fast timelines of integrating mandatory adaptations to the data systems.
Friedrich Asmus, MD
Chief Medical Officer at Oxular
Wemedoo's technology, expertise, and intimate engagement with our team in the development of the EDC, site/patient interface, and metric capabilities are unique. They provided insight and challenged the underlying assumptions...
Wemedoo's technology, expertise, and intimate engagement with our team in the development of the EDC, site/patient interface, and metric capabilities are unique. They provided insight and challenged the underlying assumptions to ensure the study's goals and objectives were clearly defined and the operating structure matched with the study's intent. Their system is not a one-size-fits-all and they adapt to the needs of the sponsor, sites, physicians, and the study requirements into a system that merges health information/data and can then become not only informative but actionable.
James Kuras
Vice President of Clinical Affairs and Operations at CENTINEL SPINE
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Common Questions
Frequently Asked Questions
What is eTMF software, and how does Wemedoo's oomnia eTMF streamline clinical trials?
An Electronic Trial Master File (eTMF) is a digital system designed to organize, store, and manage all essential clinical trial documents. As an integral part of Wemedoo's unified clinical research software, oomnia eTMF automates routine document workflows, reduces manual errors, and accelerates trial timelines. It ensures centralized access, regulatory compliance, and real-time inspection readiness throughout the entire study lifecycle.
What are the key features of oomnia eTMF software?
oomnia eTMF includes a comprehensive suite of tools designed to reduce administrative burden and enhance trial management, including: Centralized document storage and secure archiving, Real-time inspection readiness dashboards, Automated document workflows and strict version control, Advanced data encryption and Two-Factor Authentication (2FA), Role-Based Access Control (RBAC), Native integration with EDC, CTMS, and RTSM.
How does oomnia eTMF ensure regulatory compliance and inspection readiness?
The software is purpose-built to comply with ICH GCP, FDA 21 CFR Part 11, and strict international regulatory standards. It empowers users to host audits and inspections with absolute confidence by maintaining complete, unalterable audit trails, enforcing document lifecycle management, and providing real-time completeness tracking against the TMF Reference Model.
Can the eTMF structure be tailored to our specific clinical trial requirements?
Yes. While oomnia eTMF is built to support the standard CDISC eTMF reference model, its architecture is highly flexible. Trial teams can easily implement ISO 14155:2020 or customize the system to match any specific internal nomenclature, TMF index, or unique structural requirement.
What is the benefit of a unified eTMF compared to a standalone eTMF?
A unified solution like oomnia eTMF connects natively with all other oomnia modules (such as EDC and CTMS) within one ecosystem. It automatically receives documents and milestone updates across the platform, eliminating manual dual-uploads and heavily reducing the risk of missing documents. This leads to higher completeness rates and a significantly lighter administrative burden compared to siloed, standalone systems.
Can oomnia eTMF integrate with our existing third-party clinical trial systems?
Yes. In addition to its seamless native integration within the unified oomnia ecosystem, the software fully supports interoperability with third-party systems through secure, standard APIs and flexible data exchange formats.
How does the system support remote collaboration and data security among trial teams?
oomnia eTMF enables secure remote access, allowing sponsors, CROs, and site staff to review and contribute to trial documentation from anywhere in the world. Transparency and security are maintained through strict role-based permissions, ensuring that only authorized stakeholders have access to specific documents and insights.
What file types can be stored in oomnia eTMF?
The platform supports a vast array of file types to accommodate diverse clinical and statistical data, including but not limited to: Documents & Data (.pdf, .txt, .csv, .xlxs, .xml, .xsl, .dtd, .xsd), Images & Web (.jpg, .png, .svg, .bmp, .html, .htm), Audio & Video (.mp4, .mp3, .mpeg, .wmv, .wav), Statistical & Medical Imaging (.xpt, .xport, .sav, and DICOM files generated by medical imaging devices).
How can I book a demo and experience oomnia eTMF for myself?
Experiencing oomnia is easy. Simply click the "Request a Demo" button on this page, select an available date in our booking tool, and fill in your basic information. An oomnia expert will send you an invitation to explore how our software can streamline your specific clinical trial workflows.
oomnia offers eight essential, fully interoperable tools for easier
clinical study management. Integrate seamlessly with existing systems, use
only what you need, and capture real-time data from multiple digital
sources.
