Timely completion of necessary studies is a critical element of drug development, bringing important treatments to patients in a safe and cost-efficient way. A consideration with a measurable impact on early-phase clinical studies is the location where trials are performed; this is especially true for first-in-human (FIH) trials.

Conducting early-phase clinical research on novel compounds in Canada can provide significant advantages versus other locations.

In Issue 31 of The Altascientist, we take a deep dive into these advantages, covering:

• Canadian CTA trials–time and cost savings
• Regulatory review process predictability
• Business efficiency cost savings
• Clinical trial participants

LAUNCHING CLINICAL TRIAL APPLICATIONS (CTAs) IN CANADA

To initiate a clinical trial in Canada, a Clinical Trial Application (CTA) specific to the given study is submitted to Health Canada (HC) for approval, along with submission of study materials to an Ethics Review Board. The studies conducted under a Canadian CTA can be used to support an IND in the U.S., or a marketing authorization application in the EU, the UK, and any other regulatory regions, such as Asia and Brazil.

Studies in Canada are conducted in accordance with the International Conference on Harmonisation (ICH) guidelines, are of high quality and compliant with regulatory and ethical standards, and are routinely used to support drug applications by global regulatory agencies, including the U.S. FDA and European Medicines Agency (EMA).

A well-planned clinical program designed to meet all the regulatory requirements for the jurisdictions where you plan to request market authorization can be conducted cost-efficiently, safely, and in a timely manner in Canada. In fact, the majority of studies conducted at Canadian early-phase CROs are used for ex-Canadian submissions. 

ALTASCIENCES’ EXPERTISE IN CLINICAL STUDIES IN CANADA

Altasciences has a clinical pharmacology unit (CPU) in Montréal, Québec, Canada, and the expertise to ensure efficient, compliant trial conduct. In 2022, Altasciences submitted 45 innovator CTAs (30-day default review) which represents almost 30% of the total Health Canada CTA submission volume for 2021-2022. We also submitted 46 bioavailability/bioequivalence (BA/BE) CTAs, which corresponds to 25% of the total Health Canada BA/BE CTA submission volume for 2021-2022. 

In addition to designing, conducting, and reporting on clinical trials, Altasciences provides preclinical, bioanalytical, data management, and biostatistics solutions that bring additional efficiencies and savings. Altasciences’ integrated offerings in manufacturing are also a benefit, as your program is developed, analyzed, and approached holistically from the start.

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