A well-planned clinical program designed to meet the regulatory requirements for the jurisdictions where you plan to request market authorization can be conducted in Canada in a cost-efficient, safe, and timely manner. Many pharmaceutical and biotechnology companies have turned to conducting early phase clinical research in Canada for earlier access to FIH data, cost savings, and high-quality science and study participants. Let’s take a closer look at some of these advantages.
1. Earlier Access to First-in-Human (FIH) Data
In Canada, FIH clinical trials can be started before Investigational New Drug (IND) approval, and study participant recruitment/screening can be conducted in parallel with the Clinical Trial Application (CTA), following Institutional Review Board approval (see the diagram below). The CTA process itself is also streamlined, with a 21-day timeline. The benefit of these shorter timelines and overlapping activities is the opportunity for significantly earlier access to critical FIH data. The data from the FIH studies can then be used to strategically enhance the IND submission in the U.S.A.
2. Cost Savings
There are several ways you can realize cost savings by conducting clinical research in Canada:
For companies that have a presence in Canada, attractive tax credits can contribute to the cost-effectiveness of the development program. Read more about the Scientific Research and Experimental Development (SR&ED) tax incentives and provincial and territorial research and development (R&D) tax credits on the Government of Canada website.
Favorable Exchange Rates
The Canadian research environment operates at the same level of technological and scientific advancement as the U.S.A., with a lower currency value that can directly benefit clients.
3. Clinical Research Quality in Canada
4. High-Quality Participants
Healthcare in Canada is delivered through a publicly funded system referred to as Medicare, which is administered universally, and is free at the point of use. This initiative is supported by the Government of Canada and managed by each province individually. The intent is to assure a “continuum of care” across the country. This healthcare management philosophy has allowed pharmaceutical and biotechnology communities to leverage the high quality of participant health for pivotal early phase clinical trials. The continuum of care means patient health is properly managed, making recruiting for trials more efficient.
5. Ease of Access to Clinical Teams
For clients in the U.S.A., a Canadian CRO provides relative physical proximity and the same time zones, allowing for live interactions and efficient program monitoring. Same-day travel is possible between many points, and in most cases, visas or other travel documents are not necessary (depending on the nationality of travelers). This facilitates smooth program deployment and ongoing interactions.