Intelligent Trial Master File
The electronic trial master file or eTMF aggregates all essential documentation relating to a clinical trial, with the goal of being able to evaluate the conduct of the trial and the quality of the data produced and to reinstate the trial retrospectively.
With its specific add-on’s, eTMF can manage very complex data flows, handling the entire end-to-end process from document content upload and migration, through quality checking and approval to archival with retention scheduling. Through these processes you have the complete traceability of each action performed on your data, ensuring compliance with current regulations
SIGN+, Creates a digitally signed validated archive, which can be viewed instantly for inspections and demonstrates data integrity and accessibility via the neuronOS cloud service
BRAIN+, Adds AI powered indexing and archiving to innovative digital asset management for higher quality output and better decision making, enabled by text mining, machine learning, and data automation
REPORT+, Integrated reporting with dashboards and live filtering. Designed with the information demands of authorities and the public in mind, more practical and reliable reporting processes can be executed
TRAIN+, Deploy effective and timely training records and analyze and report on the training status in your organization when integrated with the biomeducation learning hub LMS
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
Accurate Quality Tracking
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
Validated & Controlled
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
Trial Master File solution to securely review and audit TMF documentation. Digital process support with form-based workflow for the complete (pre-) clinical document processes. Visualize real-time completeness based on study, country and site indicators. Apply filters and different dimensions, view metadata to intuitively navigate through complex eTMF filings. Recently for each document in the eTMF system, the Clinical Trials Directive (CTD) and the General Data Protection Regulation (EU) 2016/6792 (GDPR) will be relevant and apply simultaneously.
The TMF is the cornerstone of inspection readiness and sponsors and organizations must employ strategies to ensure that their TMF is prepared for possible inspection by the health authority from the beginning of each study.
This is very important since many 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). Thus, the eTMF guarantees adherence to GCP-ICH standards, regulatory and GDPR 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 artifacts, the collaboration between stakeholders seems almost impossible.
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 through 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.
Computer System Validation
We create all documents necessary for the computer system validation for you or together with you. From the validation plan to the validation report. We have been providing this service to our customers for twenty years - our documents have been used in countless audits.
- Validation Plan
- Risk Analysis
- Traceability Matrix
- Test Plans
- Test Protocols
- Test Reports
- Much more!
Regulatory Operations Services
The team at biomedion has extensive and diverse submission experience and is ready to assist with your specific needs. We specialize in the planning, processing and submission of original and lifecycle submissions to Health Authorities. We are submission and eCTD subject matter experts and offer flexible and efficient support for all stages of a regulatory application.
- Original Applications
- Lifecycle Applications
- Promotional Materials Submission
- Submission Planning
- Templates and Formatting
We advise you on the use of our solutions, make the necessary configurations for them or develop adaptations, e.g. for the integration of other products. In doing so, we work closely with our colleagues in the computer system validation department.
- System integration