For many Bellberry approved clinical trials, notifications or amendments are required as a result of the altered environment due to COVID-19. We have streamlined our processes to make the process as straightforward as possible for your studies to remain compliant.

To assist you, Bellberry has developed a batch submission pathway to allow a single submission of notifications or amendments applicable across multiple studies and/or multiple sites for consideration by Bellberry’s HRECs. Upon your authorisation, we are also able to add the notification/amendment to each relevant application in eProtocol. Following this, our standard procedure of review and decision outcome will take place.

For more information on how we can help you with COVID-19 related amendments please see MAR G8 batch submissions and MAR F8.1.1 batch submission application