F.A.I.R.

TRIAL MASTER FILE MANAGEMENT

iTMF

Navigate your entire Trial Master File in just one simple cloud interface from any desktop, laptop, tablet or mobile

Industry-standard eTMF Reference Model for document artifacts
GCP-ICH standards
Regulatory and GDPR compliance
Inspection ready

Mockup iTMF - Navigation in one simple cloud interface

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.

F.A.I.R. Platform

best practise

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.

HOW TO ENSURE REGULATORY COMPLIANCE THOUGHT ALL THE PHASES OF THE TRIAL

whitepaper

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.

Flow iTMF

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

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

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

WATCH+

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.

SIGN+

Create 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 machine learning & data automation.

REPORT+

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.

COMPLY+

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.

TRAIN+

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.

IMAGE+

Embed interactive image spheres of high resolution and complex 3D and 2D images or simply present static images with textual, visual and audio annotations.

BYOD+

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.

MIGRATE+

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.

Designers can design

Design is not only the most effective differentiator but also has a huge impact on usability of a product. Bringing all aspects of a users experience down to a consistent and frictionless system of colors, forms and shapes with optical and ergonomic advantages demands for a holistic view on human interaction with machines.

DIGITAL, DECISIVE, COMPLIANT
AND INSPECTION-READY

Engineers can build

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

DIGITAL, DECISIVE, COMPLIANT
AND INSPECTION-READY

Salespeople can sell

The perfectly engeneered product with even a wonderful design cannot be successful in the market, without someone, who finds the market and points out the advantages for a prospective customer. Selling products that solve complex problems is an art in itself and involves a good understanding of technology, user and psychology.

ALL DIGITAL, DECISIVE, COMPLIANT, AND INSPECTION-READY

Infographics neuronOS best practice applications iTMF

Related Processes

CAPA Management

To understand how to achieve quality in a regulated industry, you need to know that corrective and preventative actions (CAPA) are essential elements of quality management in GxP environments. The CAPA process is a commonly used tool to achieve operational excellence by identifying and mitigating non-conformances and deviations, both internally and externally.

Change Control

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.

Deviations Management

The management of deviations is not just a GMP concept, it spans the entire product life cycle, including Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) and Process Deviation Management.

High Content Screening

High-content screening (HCS), also known as high-content analysis (HCA) or cellomics, is a method that is used in early development stages and drug discovery to typically identify substances such as small molecules, peptides, or relevant RNAi that can lead into development candidates for future medicines.

Image Annotation

With the development of diagnostic imaging devices, large amounts of digital high-res and 3D images are generated every day. The requirements of effective indexing and searching image are growing rapidly. Image annotation is an effective way for content-based image retrieval.

CRO Collaboration

The last few years have seen tremendous consolidation in both the pharmaceutical and contract research industries. The impact among pharma companies has created a heightened demand for productivity.

Remote Image Analysis

Imaging data in diagnostics and research is growing at an unprecedented rate, coming from all kinds of sources. The con-focal and high-resolution microscopy, artificial intelligence, and any other new computer-tomographic (CT) technologies create vast amount of data. When researchers start to collaborate over distances with imaging centers, using diagnostic services over internet connections, the bandwidth and computation power easily exceeds the capabilities in remote areas.

Inspection Management

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).

SOP Management

Life science organizations developing or manufacturing pharmaceutical products will typically create, maintain and execute large amounts of standard operational procedures (SOP). The solid change control and deployment of SOPs are a fundamental to achieve compliance excellence.

Raw Data Management

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.

Training Management

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.