Our regulatory database of over 40+ Central Laboratory and Sample Collection Site country requirements for IVD/CDx clinical performance/validation studies. This tool helps companies navigate the complex and ever-changing regulatory landscape by providing easy access to difficult to source information such as submission to National Competent Authority and Research Ethics Committees as well as requirements for Safety Reporting and links to applicable country legislation, submission portals and and guidance provided in an easy to navigate platform.
Article written by ARC Insights
ARC Insights offers a mix of industry specific content with the aim to keep its readers informed, educated, and up to date with the latest developments, trends, and expert knowledge in the FiH translational medicine space.
