biomedion’ electronic Trial Master File solution - neuronOS Protocol - enables sponsors, investigators and CROs to easily demonstrate compliance and control over their clinical document processes. neuronOS Protocol for eTMF allows internal and external staff to securely review, audit, inspect, and search TMF documentation from any location in accordance with ICH and 21 CFR Part 11 guidelines.
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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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.
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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.
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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.
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Post implementation training services relate often to process changes. With biomedion training services implementations are ready for success. The neuronOS Learning Management System (LMS) typically handles the processes related to ramp-up and adoption planning after larger implementations.
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For further information please contact us, we look forward to hearing from you.
