Overview of Clinical Data Sharing and Data Anonymization

Need for Data Sharing For biomedical research, Clinical trials are essential components as they lay down the foundation for the researchers to investigate the significance of various treatments and interventions given to humans for disease cures.  The urgency for Clinical Trial Transparency is highlighted by the Declaration of Helsinki and the World Health Organization. It […]

EMA policy 0070 Relaunch in September 2023 – What you should need to know! 

Clinical Trial Regulation and EMA Policy 0070 restart

EMA Policy 0070 is to be relaunched in September 2023. This was announced by the European Medicines Agency during a webinar held on May 16, 2023.  All Marketing Authorization Holders who submit packages to EMA should immediately implement document anonymization processes.  EMA Policy 0070, which was originally implemented on January 1, 2015, has been around […]