Streamlined trial master file management with oomnia eTMF
Manage your Documents Efficiently and be Inspection-Ready at any Time
- N Enhanced oversight
- N Flexible eTMF structure
- N Real-time reporting
- N Increased collaboration
Manage your Documents Efficiently and be Inspection-Ready at any Time
- NEnhanced oversight
- N Flexible eTMF structure
- N Real-time reporting
- N Increased collaboration
Discover the capabilities of oomnia eTMF firsthand
As a tool of our unified software, oomnia eTMF ensures seamless data flow and consistency across all trial aspects. 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.
Harness the Efficiency of oomnia eTMF
Streamline your trial documentation
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 these 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. This process is 3-5 times faster than the competition, leading to faster trial start-up times.
Benefits of our unified eTMF
Boost your clinical trial success
Exceptional Quality
Real time integrated graphical reports enable a customizable overview ensuring that the eTMF is completely inspection ready and changes are traceable. Expected by dates for uploads and approvals and notifications thereof increase timeliness and eTMF quality. A full audit trail ensures enhanced transparency and traceability.
Enhanced flexibility
The eTMF structure can be adapted to match trial-specific demands. oomnia eTMF swiftly tailors forms to fit trial needs, surpassing the competition. Moreover, oomnia eTMF accelerates setup by 3-5 times, boosting efficiency and easily adjusts to changes, ensuring agile trial management.
Error Reduction
Our eTMF specialists create a well-organized structure, minimizing errors during document organization. Pre-created placeholders provide users with a clear framework, reducing the likelihood of errors when uploading documents. Integrated graphical reports allow for the easy detection of missing documents.
Time Savings
An eTMF can be et up for a new study by reusing eTMF index and structure from previous trials. Furthermore, training time is reduced by reusing roles and permissions.
Cost Savings
Advanced Features of oomnia eTMF
Maximize your clinical trial efficiency
Cultivating excellence in clinical trial management, oomnia eTMF offers a suite of key features tailored to the needs of the most demanding professionals in the field, whether you are a clinical data manager, trial director, study coordinator, or cinical research associate. Explore how our software facilitates streamlined communication, simplifies document management, and ensures real-time inspection readiness for your clinical trials.
User-friendly document management
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/change of record is required from 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
Reliable access control and security
Safeguard your clinical data 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
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
Why oomnia
Integrated EDC, RTSM, ePRO, eCOA, eSource, CTMS, and eTMF
- Unified SaaS-solution
- Real-time analytics
- Full interoperability
- Unmatched user experience
- Easy learning curve
- Adaptive flexibility
- Exceptional services
- Instant collaboration
- Swift validation process
Regulatory compliance
Maintain compliant with trial standards
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
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
Efficient document administration
Streamline your trial’s document management process
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
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Audit and inspection readiness
Prepare for every review and compliance check
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
Enhanced versioning and change tracking
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
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
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Complementary services
Unlock more possibilities
eTMF setup and administration
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.
Biostatistics and statistical programming
Before the study’s commencement, biostatistical methods are used to oversee the study design in terms of calculating the sample size, and providing randomization solutions to compose a scientifically sound performance. As the data collection is complete and clinical study brought to a close, biostatistics provide a quantitative framework for interpreting the study results. Learn more about our Biostatistics and Statistical Programming service.
Medical writing and documentation
Our team of expert medical writers create clear, comprehensive, and regulatory-compliant documentation essential for all phases of your clinical research. From clinical study protocols and study reports to scientific publications, our service ensures your clinical trial documentation is meticulously crafted and aligned with the highest industry standards. Get more information about our Medical Writing and Documentation service.
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."
"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."
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Frequently asked questions
Get the answers you need about oomnia eTMF
What is oomnia eTMF, and how does it streamline clinical trial document management?
oomnia eTMF is a comprehensive electronic trial master file system designed to store and manage various records related to clinical trials. As it is an integral part of the unified oomnia clinical research software, it streamlines document management, reduces errors, and accelerates trial timelines by automating tasks and reducing user burden.
What file types can be stored with oomnia eTMF?
Can stakeholders access and contribute to trial documentation remotely using oomnia eTMF?
Yes, oomnia eTMF offers remote access, allowing stakeholders to review and contribute to the eTMF from different locations, promoting efficient collaboration.
How does oomnia eTMF ensure inspection readiness and compliance with regulatory standards?
How does oomnia eTMF enhance transparency and access control among trial teams?
Can oomnia eTMF be tailored to specific clinical trial requirements and internal nomenclature?
Yes, while oomnia eTMF has been created to support the CDISC eTMF reference model, it is flexible enough to easily implement ISO 14155:2020 or any other TMF index or structure necessary.
How can I book a demo and experience oomnia for myself?
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