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
Streamlined trial master file management with oomnia eTMF

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.

eTMF features
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Benefits of our unified eTMF

Boost your clinical trial success

Experience the profound benefits of oomnia eTMF – a catalyst for unparalleled efficiency and excellence in clinical trial management. Dive into the advantages of significant time and cost savings, alongside a commitment to delivering high-quality results for your clinical trial.

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

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  • 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

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  • 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

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  • 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

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

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  • 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

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  • 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

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  • 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

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  • 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

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  • 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

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  • 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

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  • 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

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  • 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

All of the tools oomnia provides are part of a unified system and support multiple trials on a single instance. Learn more about the full potential of oomnia.
  • 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

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

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  • 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

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

CDISC TMF reference model compliance

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

Reporting

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  • 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

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  • 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

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

CDISC TMF reference model compliance

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

Reporting

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  • 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

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

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  • 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

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

Search and filter functions

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  • 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

Proud to be a member of cdisc
Since November 2020, we have been a part of the Clinical Data Interchange Standards Consortium. It is our concern to improve the quality and efficiency of clinical research.

Audit and inspection readiness

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

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  • 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

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  • 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

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  • 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

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  • 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

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  • 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

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  • 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

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  • 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

:
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  • 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

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  • 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

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  • 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 our journey to advance clinical research together.

Complementary services

Unlock more possibilities

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.

eTMF setup and administration

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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

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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

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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."

Georg Mathis, PhD

CEO Appeltree 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 looking forward to our next project together."

Volodymyr Stus, MD

Biopharmaceutics and Clinical Research Department Manager at Polpharma SA

INTRIGUED BY THE INSIGHTS?

Take the next step in advancing your clinical research with us now

Frequently asked questions

Get the answers you need about oomnia eTMF

What is oomnia eTMF, and how does it streamline clinical trial document management?

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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?

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A wide range of file types can be uploaded to the oomnia eTMF. These include, but are not limited to .txt, .bmp, .csv, .dtd, .xlxs, .xml, .xsl, .html, .htm, .jpg, .mpeg, .mp3, .mp4, .pdf, .png, .xpt, .xport, .svg, .sav, .wmv, .wav, .xsd, and files generated by statistical software and medical imaging devices (DICOM files).

Can stakeholders access and contribute to trial documentation remotely using oomnia eTMF?

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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?

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The oomnia eTMF audit trail, document version history, customizable integrated graphical reports, and access control contribute to inspection readiness, enabling users to host audits and inspections with confidence.

How does oomnia eTMF enhance transparency and access control among trial teams?

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oomnia eTMF provides access control based on user roles and permissions, ensuring that the right stakeholders have access to the appropriate trial documents. It also ensures that the right roles have insights into all aspects of eTMF operations.

Can oomnia eTMF be tailored to specific clinical trial requirements and internal nomenclature?

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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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In order to book a demo call with an oomnia expert, simply press the button below, select a date in the booking tool and fill in all necessary information. After that, we will send you an invitation.

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