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.
Create a digitally signed validated archive, which can be viewed instantly for inspections and demonstrates data integrity and accessibility via the neuronOS cloud service.
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.
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.
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.
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.
Embed interactive image spheres of high resolution and complex 3D and 2D images or simply present static images with textual, visual and audio annotations.
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.
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.
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
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 conciousDIGITAL, DECISIVE, COMPLIANT
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
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 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.
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 (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.
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.
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.
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.
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).
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.
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.
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.
intelligent trial master file
Processes, Documents, DIA eTMF, CRO Migration, Longterm Archiving
As well as all other Add-ons ...
intelligent and quality conscious archiving solution
R&D, Clinical Data, Non-Clinical, Quality Docs, SDTM, SEND
As well as all other Add-ons ...
intelligent raw data archiving watcher
Processes, Documents, RAW Data, GxP Lab, Controls, SEND, loT
As well as all other Add-ons ...