New UK guidance explains how clinical trial sponsors and investigator sites can ensure that trial monitors securely process data in electronic health record systems that do not have a restricted access functionality.

Swissmedic says its good manufacturing practice certificates remain valid for longer than companies might assume. Separately, it is giving companies more time to conduct nitrosamine-related risk evaluations.

In the second segment of a two-part article on transparency provisions for the new EU clinical trial portal, a senior Merck executive explains how the company will ensure that commercially sensitive information and personal data in its clinical trial applications are not made public.