Study Archive
PHT Study Archive is a stable record of all trial eCOA data including audit trails, screen shots and signatures for trial reconstruction and regulatory review. All PHT eCOA system components, including the Archive meet regulatory requirements of the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), the European Union (EU), the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and the Pharmaceuticals, and Medical Devices Agency in Japan (PMDA). Data you can and regulatory authorities trust.