en, Guidelines & Regulations

What’s the difference between Canada and US: CTA versus IND?

If you are a Sponsor/CRO conducting clinical research in both Canada and the U.S., there are important differences between the Canadian Clinical Trial Application (CTA) and the U.S. Investigational New Drug (IND) submission process. IND Submission Process in the U.S. In the U.S., once the IND has been submitted for review, the FDA has 30 […]

en, Guidelines & Regulations

Do we have to register this clinical trial? Why? On which registry?

Are you involved in multi-national clinical research in North America? Are you wondering whether – and where – you have to register a clinical trial? And why? Why should we register this clinical trial? Let’s address the ‘why’ question first. Registration is internationally recognized as a scientific, ethical and moral responsibility that “will improve research […]