Most medtech companies can’t seamlessly exchange product information between in-country and global regulatory assurance teams, according to the 2023 Regulatory Benchmark Report from Veeva MedTech. Without a standardized and consistent way to share documents globally, organizations can’t ensure the reliability or accuracy of product information across markets. This increases compliance risk.
Tag Archive for: data quality
Med Ad News talked to Florence Healthcare Chief Clinical Trial Officer Catherine Gregor regarding the state of clinical trial site enablement technology in 2023.
In December 2021, the FDA issued draft guidance to lifescience researchers on evaluating EHR and claims data in studies to support regulatory decisions. This new draft guidance covers using real-world data from these sources to support regulatory decisions on both safety and effectiveness.
