eTMF & ARCHIVING

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

 

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BEYOND JUST TRIAL MASTER FILE MANAGEMENT

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. 

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TRIAL DOCUMENTATION
  • 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
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
INSPECTION READINESS
  • 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

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. 

 

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  • 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.

Data
Dossiers
Documents
Digital Forms
Digital Assets

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

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RESOURCES

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Inspection Management

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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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iRAW


intelligent raw data archiving watcher
Processes, Documents, RAW Data, GxP Lab, Controls, SEND, loT

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iPQM


intelligent pharma quality management
Processes, Documents, QMS, qDMS, CAPA, Image QC, Issue Management

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iTMF


intelligent trial master file
Processes, Documents, DIA eTMF, CRO Migration, Longterm Archiving

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iRCS


intelligent regulated content services
Processes, Documents, rDMS, RIM robot, IDMP/SPOR, promo mats

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iARQ


intelligent and quality conscious archiving solution
R&D, Clinical Data, Non-Clinical, Quality Docs, SDTM, SEND

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CONTACT US

For further information please contact us, we look forward to hearing from you.

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INDUSTRIES

Biotech

The broad concept of “biotechnology” or also known as "BioTech" encompasses a wide range of procedures. The global market for the biotechnology market is primarily driven by technologies like DNA sequencing, nano-biotechnology, tissue engineering and regeneration, cell-based assay, PCR technology, and others. Explore the flexible solutions for emerging BioTech

 

Pharma

The pharmaceutical industry develops drugs or devices to diagnose, cure, treat or prevent diseases. Pharmaceutical companies produce both generic and branded drugs. Pharmaceutical drugs are subjected to various laws and regulations that deal with patenting, testing, safety, efficacy and marketing. Pharmaceutical drugs are intended for human or veterinary use presented in their finished dosage form. Learn more about the Process excellence of biomedion in Big Pharma.

 

CRO

A contract research organization (CRO) is a company that offers services to the pharmaceutical and biotechnology industries. These companies partner with various companies and organize and conduct clinical trials to test the new molecule before obtaining approval. Contract manufacturing organizations (CMO) offer manufacturing services, with volume capabilities ranging from small amounts for preclinical R&D to larger volumes necessary for clinical trial purposes and commercialization. See how biomedion enables functional service provision with CROs.

 

CMO

A contract manufacturing organization (CMO) is an organization that serves the pharmaceutical industry and provides clients with comprehensive services, from drug development to manufacturing. Outsourcing to a CMO allows the pharmaceutical clients to expand their technical resources, without increased overhead. Arivis offers solid solutions for contract manufacturing.

 

GLP Laboratory

Third-Party Laboratories for GLP Testing, contract testing laboratories. Pharmaceutical manufacturers contract out any quality control testing, will need a licensed laboratory, certified as a GMP or GLP. The GLP laboratories are designed to protect scientific data integrity, and to provide the EPA or FDA with a clear and auditable record of open-ended research studies. With a biomedion you are committed to integrity with contract testing laboratories.

 

Diagnostic Microscopy

Microscopes have enabled researchers to conduct in-depth academic and exploratory research. The biomedical research and engineering sector is driving innovation by microscopy techniques to produce better and more informative images of cellular functions, including internal images of cells.