Navigate your entire eTMF in just one simple cloud interface from any desktop, laptop, tablet or mobile and be supported by the industry-standard eTMF Reference Model for document artifacts




Are you under a lot of pressure right now? Feeling overwhelmed with tedious paperwork or trying to figure out how to use complicated software? To comply with regulatory government policies, clinical research organizations need to keep records of essential documents that are stored in the trial master files (TMF). The TMF allows independent auditors and regulatory authorities to monitor and evaluate the quality of the data produced by a clinical study. Thus, it guarantees adherence to GCP-ICH standards and regulatory compliance. However, trial master files can represent a significant challenge in a clinical trial environment, especially if it relies on paper-based systems. Due to the global nature of clinical trials and the large volume of documents generated, the collaboration between stakeholders seems almost impossible. 

Besides, it may be difficult to ensure regulatory compliance thought all the phases of the trial, to recover missing data, and to track the status of document submissions or follow up. All of this is a formula for disaster. When there´s no room for error, you must be able to readily access TMF files to make the best-informed clinical decisions. 


  • Combine documentation and data from compliance, regulatory and digital imaging in one ecosystem
  • Interactively modify document metadata during upload
  • Identify ‘living’ documents and where they are located
  • Customizable user roles enable easy access at the correct level for all users
  • Improve the accuracy of documents with quality check workflows
  • Easy editing of documents with Office 365 integration
  • Single central location for all documents increases visibility and oversight
  • Filter and search for documents by Reference Model zones, sections and milestones
  • Always manage documents in one system to stay Inspection Ready
  • Increase Inspection Readiness through quality, timeliness and completeness management
  • Easily navigate to the correct study, country, site, zone, section or document
  • Easy to use and simple structure for instant access and control
  • Ensure GCP compliance with embedded workflows, dashboards and reports
  • Seamlessly integrate eTMF quality processes and workflows into your organizations’ business requirements
  • Standard placeholder templates enable fast access for document uploading

Benefits of neuronOS - Features Overview

neuronOS eTMF is an out-of-the-box, cloud-based solution that includes repositories defined in the Drug Information Association's best practices for Clinical Electronic Trial Master Files (DIA eTMF Reference Model).

Our solution helps you manage all eTMF artifacts more efficiently with a complete cloud-based document management system especially projected to facilitate any eTMF business process. 




  • Simplify and accelerate trial execution. With neuronOS you can navigate your entire eTMF in just one simple, cloud interface from any desktop, laptop, tablet or mobile.
  • Easy interaction between Sponsors, CROs and Sites. neuronOS provides a secure and collaborative space for your team to share and exchange eTMF content by allowing users to manage document completeness in real-time. 
  • Be ready for inspection. You won´t have to worry about inspections anymore. neuronOS offers an easily accessible eTMF to facilitate audits & inspections with more confidence than ever. 
  • Identify missing documents and artifacts in minutes, not months. See where documents are Expected or Completed to gain more time to focus on your patients. 
  • Manage Study, Country and Site progress as it happens. neuronOS allows you to track trial progress efficiently.
  • Use bulk import processes to allow uploading of multiple documents to the correct artifact placeholders.
  • neuronOS supports the industry-standard eTMF Reference Model for artifacts, properties, relationships and hierarchies of all documents

Thats why neuronOS eTMF is the best solution for your company.

neuronOS eTMF includes inspector portal, quality check workflows, version control, document staging areas, FTP connectivity, and a full standards-based API. Easily add neuronOS eCTD for global regulatory e-submissions. neuronOS is easy to use and is supported by one of the most user-friendly and more cost-effective licensing models amongst eTMF software providers. This means, with neuronOS you can save time and money to focus on your research. 

Don’t worry about a thing. In addition to software, biomedion provides comprehensive professional services encompassing everything related to your eTMF. You can feel secure in our hands. biomedion focuses exclusively on Life Sciences and has deployed eTMF solutions for companies of all sizes. It’s time to consider the best solution for your eTMF, and that solution is neuronOS eTMF.

Digital Forms
Digital Assets

Our applications span the entire lifecycle through drug discovery, development towards market access and continuously leverage innovation



Related Processes

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Change management is specifically designed to evaluate, redesign, and implement new business processes, where processes are defined in standard operating procedures (SOPs). A well implemented change management rewards the company with improved business processes, efficient workflows, decreased project overhead, a better risk profile and an improved company culture. 

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Regulatory agencies conduct routine inspections during active studies. In this case, documentation must be available and complete, ensuring that the study was conducted following the protocol using the principles of Good Clinical Practices (GCP).

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A clear understanding of how RAW DATA is defined, recorded, and retained in the laboratory record is essential when it comes to compliance with the Good Laboratory Practices regulations. RAW DATA in laboratories occur in various fluctuating formats and versions in a large amount of laboratory devices, LIMS and quality management systems. 

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Post implementation training services relate often to process changes. With training services implementations are ready for success. The Learning Management System (LMS) typically handles the processes related to ramp-up and adoption planning after larger implementations. 

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eTMF and Archiving
To comply with regulatory government policies, clinical research organizations need to keep records of essential documents that are stored in the trial master files (TMF). The TMF allows independent auditors and regulatory authorities to monitor and evaluate the quality of the data produced by a clinical study.
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For further information please contact us, we look forward to hearing from you.

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