In this white paper, our regulatory team presents the frameworks governing Laboratory Developed Tests in Europe and the USA, and discuss important deadlines, exceptions and the main differences in the way these tests will be overseen on these two continents.Please...
Centralized Risk Reporting, Escalation, and Governance (CRREG) Platform
According to the most recent draft of the International Council on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP) E6(R3), “The aim of monitoring is to ensure the participants’ rights, safety and well-being and the reliability of trial results as the...
Technology Landscape and Challenges of High Throughput vs. POC Diagnostics
As the world is beginning to understand, SARS-CoV-2 poses several unique challenges. Asymptomatic and infected individuals are highly contagious and present unprecedented viral transmissibility. As countries and markets try to fully understand the economic impact of...
White Paper: Introduction to EU Artificial Intelligence Act
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White Paper: How Clean is Clean Enough?
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