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.
Recover missing data, and track the status of document submissions or follow up. When there's no room for error, you must be able to readily access TMF files to make the best-informed clinical decisions.
Decentralized intelligent agents execute defined missions that correspond to actual stages of defined cloud-based business workflows, carrying capabilities to ensure end-to-end compliance.
Mitigate data-security breaches, financial risks and keep your company’s reputation. Overcome data silos that prevent standardization, transparency and compliance. Accessible to advanced AI.
In addition to storing and managing documentation online, neuronOS with ARC+ allows for digital assets to be migrated, federated, archived while staying GxP compliant at any time.
Adds AI powered indexing and archiving to innovative digital asset management for higher quality output and better decision making, enabled by machine learning & data automation.
Add value and simplify data acquisition through smartphone apps, which can check-in pictures, text, audio and data sets into any GxP compliant process, living on the neuronOS platform.
Embed interactive image spheres of high resolution and complex 3D and 2D images or simply present static images with textual, visual and audio annotations.
Integrated reporting with dashboards and live filtering. Designed with the information demands of authorities and the public in mind, a more practical and reliable reporting can be excelled.
Create a digitally signed validated archive, which can be viewed instantly for inspections and demonstrates data integrity and accessibility via the neuronOS cloud service.
Deploy effective and timely SOP training records and analyze the training status in your organization prior to inspection findings. Keep training records consistent
for long-term archiving.
Integrate diverse eTMF and Clinical Data from various sources and CROs to accelerate your research with decentralized trials. Access raw & processed Data, analyze multiple eTMF sources, integrate CRO data in sponsors eTMF archives.
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DIGITAL, DECISIVE, COMPLIANT
AND INSPECTION-READY
Building requires a vast amount of abstraction not only in a mechanical world also in virtual systems which should be able to interact between humans and machines in order to reach intended goals and create systemswhich are resource concious
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ALL DIGITAL, DECISIVE, COMPLIANT, AND INSPECTION-READY
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Processes, Documents, RAW Data, GxP Lab, Controls, SEND, loT
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intelligent trial master file
Processes, Documents, DIA eTMF, CRO Migration, Longterm Archiving
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intelligent regulated content services
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intelligent and quality conscious archiving solution
R&D, Clinical Data, Non-Clinical, Quality Docs, SDTM, SEND
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When there´s no room for error, you must be able to readily access TMF files ...
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