The FAST TRACK Evaluation Service Continues to Demonstrate Its Value in Strategic International Clinical Trials

CATALIS Québec’s FAST TRACK Evaluation Service continues to deliver tangible results for healthcare institutions, clinical trial sponsors, and patients across Quebec. Several recent projects conducted in collaboration with university-affiliated hospitals and regional healthcare institutions highlight Quebec’s ability to rapidly launch complex clinical trials and stand out on the international stage.

A First Canadian Site Activation for Kite’s (Gilead) International B-Cell Lymphoma Trial

The first Kite (Gilead) study assessed through the FAST TRACK Evaluation Service, project KT-US-499-0150 involved two major academic centres: the Jewish General Hospital University Health Centre and Santé Québec – McGill University Health Centre. Authorizations were completed within 10 to 12 weeks, while activations were achieved in approximately 11 to 12 weeks. The Jewish General Hospital University Health Centre stood out as the first site activated in Canada. The reported timelines are specific to this study and may vary based on factors such as study design, geography, regulatory requirements, site readiness, and other operational considerations.

Three Novo Nordisk Studies Highlight the Strength of Cardiovascular Research in Quebec

Cardiovascular diseases currently represent a strategic area for clinical research development in Quebec. Three international studies sponsored by Novo Nordisk, focusing on different cardiovascular conditions, particularly illustrate this momentum.

The Phase III trial HF-POLARIS (NN9490-8266) involves several Québec institutions, including Santé Québec – Institut universitaire de cardiologie et de pneumologie de Québec – Université Laval (IUCPQ), Santé Québec – CHU de Québec – Université Laval, Santé Québec – Centre hospitalier de l’Université de Montréal (CHUM), as well as Santé Québec Bas-Saint-Laurent and Santé Québec Saguenay–Lac-Saint-Jean – Universitaire. Several Québec sites obtained authorization within 9 to 12 weeks and proceeded to activation shortly thereafter.

A second Phase III trial, 8212-PRESERVED (NN6706-8212), is being conducted at IUCPQ as part of an international program involving 60 sites across 9 countries. Authorization was granted in just 8.4 weeks, once again demonstrating the efficiency of the processes in place.

Finally, the Phase IIIb trial AMBIENCE (NN9490-8037) brings together IUCPQ, CHU de Québec, Santé Québec Estrie – Centre hospitalier universitaire de Sherbrooke (CHUS), Santé Québec Saguenay–Lac-Saint-Jean – Universitaire, and CHUM as part of a large international project comprising 710 sites across 25 countries. This significant Quebec participation reflects the confidence that international sponsors place in the province’s clinical research expertise and infrastructure.

First Site Activated Worldwide and First Participant Recruited for a GSK Ovarian Cancer Trial (BEHOLD-Ovarian01)

GSK’s BEHOLD-Ovarian01 (224031) trial, conducted in patients with ovarian cancer, is another outstanding example of the impact of the FAST TRACK Evaluation Service. Conducted at Santé Québec – McGill University Health Centre (MUHC) and CHUM, this Phase III trial is part of an international program involving 200 sites across 24 countries.

The authorization and activation timelines achieved enabled the MUHC to become the first site activated worldwide and to recruit the first participant globally in the trial.

Supporting the Development of New Treatment Options for Sjögren’s Syndrome (CDDY391B12201 – Novartis)

The FAST TRACK Evaluation Service also facilitated the implementation of Novartis trial CDDY391B12201, focused on Sjögren’s syndrome, a chronic autoimmune disease for which therapeutic options remain limited. This international trial includes 226 sites across 26 countries and involves, among others, teams from Santé Québec Bas-Saint-Laurent and CHUS. At CHUS, authorization was obtained in only 6.4 weeks, and the site was activated within 13.4 weeks, illustrating the ability of Quebec institutions to efficiently support research projects in specialized therapeutic areas.

Quebec Among the First Sites Activated Worldwide for an Alexion Cardiac Amyloidosis Trial

Alexion’s first trial conducted through the FAST TRACK Evaluation Service, ATTriumph (D8456C00001), is evaluating a potential treatment for transthyretin amyloid cardiomyopathy (ATTR-CM), a rare and progressive disease affecting the heart muscle. Conducted at Santé Québec – Montreal Heart Institute (MHI) as part of a Phase IIb trial involving 79 sites across 10 countries, the trial received authorization in 12 weeks and was activated in 12.8 weeks. This performance enabled the MHI to become the third site activated worldwide.

A Strategic Lever to Accelerate Health Innovation

These recent results are part of the overall performance of the FAST TRACK Evaluation Service, whose median authorization and activation timelines rank among the fastest in Canada. They reflect the strong commitment of healthcare institutions, pharmaceutical companies, and CATALIS teams to positioning Quebec as a preferred environment for rapid clinical trial start-up.

Thanks to this collective effort, CATALIS and its Network of partners are proud to drive innovation in clinical research and to reduce authorization timelines for privately funded clinical trials by more than 65% compared to those conducted outside the FAST TRACK Evaluation Service, thereby accelerating the development of, and access to, innovative treatments for patients.

CATALIS would like to thank all its public and private partners for their trust, their contribution to the development of innovative approval processes, and their commitment to implementing accelerated clinical trials in Quebec.

Looking to accelerate the start-up of your clinical trials in Quebec?

Interested in participating in a clinical trial?

Clinical Trials Quebec, an information and services hub provided by CATALIS, offers easy-to-understand educational content, animated infographics, and free tools to help you better understand clinical research and what to expect during a clinical trial.