en, Guidelines & Regulations

How to obtain a Health Canada Research Ethics Board Attestation (REBA)

When conducting clinical trials in Canada, a Sponsor must generally possess, for each clinical trial site, a Research Ethics Board Attestation (REBA), which provides administrative information regarding the research ethics board (REB) as well as a certification that its composition, operations and decisions are in compliance with Canadian regulations. A REBA must also be completed […]

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 […]