The FAST TRACK Evaluation Service: A Strategic Lever to Accelerate Clinical Research in Quebec

Since its launch, the FAST TRACK Evaluation Service has emerged as a key lever for strengthening the efficiency of scientific, ethical, and contractual review processes related to clinical trials in Quebec. Thanks to a centralized coordination model and close collaboration with participating health institutions, this Service significantly contributes to shortening timelines leading to project approval and site activation.

To date, 277 evaluation requests have been processed, enabling participating institutions to issue their institutional authorizations within a median of 10 weeks and to activate sites within 13 weeks. These results represent a reduction of approximately 75% compared to the usual standard process, highlighting the rigor and harmonization brought by the Service.

Over the past four years, this Service has demonstrated its concrete impact: it accelerates clinical trial start-up, thereby supporting access to innovation for sponsors and institutions, while allowing patients in Quebec to participate more quickly in clinical studies essential to the development of new treatments.

Two New Health Institutions Join the CATALIS FAST TRACK Evaluation Service 

The FAST TRACK Evaluation Service continues to grow, and we are proud to announce that two new Health and Social Services Institutions (HSSIs) will soon be offering this Service. The CISSS de la Montérégie-Est and the CIUSSS de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ) are one of 21 institutions that have been participating in this initiative to fast track the start of clinical trials in Quebec since 2022.

Each new HSSIs that joins the FAST TRACK Evaluation Service strengthens Quebec’s capacity for a faster delivery of clinical trials to the entire population. By expanding this network, we are increasing opportunities for patients across Quebec to gain earlier access to innovative research options. These strategic partnerships strengthen Quebec’s position as a leader in health innovation, while fast tracking the evaluation and development of new medical approaches for the population.

Roche Breast Cancer Study: Three Quebec Institutions in the Top 3 Worldwide 

Thanks to support from each of the FAST TRACK Evaluation Service’s stakeholders, three Quebec hospitals stood out on the international stage for the speed with which they implemented the second phase of Roche’s neoTOV breast cancer study.

The Jewish General Hospital (JGH), with Dr. Stephanie Wong, was the first site activated worldwide.

The McGill University Health Centre (MUHC), with Dr. Jamil Asselah, ranked as the second site activated worldwide and recruited the first patient worldwide.

The Centre hospitalier de l’Université de Montréal (CHUM), with Dr. Rami Younan, was the third site activated worldwide.

Institut de Cardiologie de Montréal Recruits the World’s First Participant in a Novartis Cardiology Study

The Institut de Cardiologie de Montréal (ICM - Montreal Heart Institute) has recruited the world’s first participant for the Novartis phase IIa study CPKN605A12201 on atrial fibrillation. Through the FAST TRACK Evaluation Service, and under the leadership of Dr. Laurent Macle and his team, the ICM obtained a 10.8 week authorization time and a total activation time of 12.4 weeks.

The FAST TRACK Evaluation Service has also enabled four other Quebec health institutions to authorize the study quickly, with a median time of 11.3 weeks: the Centre hospitalier de l’Université de Montréal (CHUM), the Centre hospitalier universitaire de Sherbrooke (CHUS), the Centre universitaire de santé McGill (MUHC) and the Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ).

This collective performance confirms Quebec’s leadership in the rapid implementation of world-class clinical trials in its health institutions, for the benefit of patients.

The CHUS Ranks First in the World for a Sanofi Study on a Rare Inflammatory Disease

The team lead by Dr. Hugues Allard-Chamard at the Centre de recherche du Centre hospitalier universitaire de Sherbrooke (CRCHUS) stood out on the international stage by becoming the first site worldwide to be activated, ahead of 97 other sites in 19 countries, for a phase III study by Sanofi on IgG4-related disease.

With authorization received in 7.6 weeks and a total activation time of 9 weeks, the CHUS, with the FAST TRACK Evaluation Service’s support, is being recognized as a key player in research on this rare and still poorly defined inflammatory condition.

New “Clinical Research 101” Courses: A Comprehensive Introduction Program for the General Public, Researchers and Research Teams

As part of its mandate to strengthen the clinical research ecosystem in Quebec, CATALIS is continuing the progressive roll-out of the Clinical Trials Quebec (CTQ) training program. After launching several tools and capsules for research professionals, we are pleased to present a new series of introductory training courses under the title Clinical Research 101 to provide accessible content tailored to a variety of audiences.

These modules, designed to meet the diverse needs of the general public, researchers and research teams, seek to harmonize the core knowledge essential for understanding, supporting or undertaking clinical research activities.

The new Clinical Research 101 Modules:

• Clinical Research 101 for the general public: These awareness-raising capsules are aimed at those who wish to better understand the mechanisms, benefits and risks of clinical research. Available in both short and long versions, it provides the general public with a level of information tailored to their needs.

• Clinical Research 101 for researchers: Designed specifically for researchers just starting out in clinical research, this interactive course complements the general introductory module. The training will be available soon. Stay tuned!

• Clinical Research 101 for research teams: This introductory training is intended for anyone starting out in human research, whether directly involved in studies or in administrative and technical support.

The development of these new training courses builds on the work done by the public and private members of our committees. We thank them for their expertise and commitment to advancing research practices in Quebec.

And we are just getting started! More educational content is already being prepared to continue enhancing the provincial training program and support all clinical research participants.

A New Resource for Clinical Research Sponsors in Quebec

Following the launch of the Clinical Trials Quebec (CTQ) website for the general public, we are pleased to announce that the CTQ Sponsors website was officially launched in December 2025.

Powered by CATALIS, with support from the Government of Quebec, CTQ Sponsors showcases Quebec’s clinical research expertise and excellence. It provides a hub of strategic information featuring practical resources, high‑performance tools, and personalized support to assist sponsors in planning and conducting their research projects in Quebec.

Featured on the website:

✅ Directory of Health Institutions

✅ Directory of Biotechnology Service Providers and Private Clinics

✅ Directory of Patient Organizations, Patient Partners, and Treatment Guidelines

✅ FAST TRACK Evaluation Service

✅ Access to Quebec Health Data

✅ Medical Device Classification Tool

✅ Process for Bringing Your Innovations to the Market

✅ Guidance for Setting Up Your Company in Quebec

As with all initiatives led by CATALIS, this website is the result of exceptional collaboration among Quebec’s public and private stakeholders. We extend our sincere thanks to Investissement Québec, BIOQuébec, Health Canada, the Institut national d’excellence en santé et en services sociaux (INESSS, National Institute of Excellence in Health and Social Services), and the Ministère de l’Économie, de l’Innovation et de l’Énergie (MEIE, Ministry of Economy, Innovation and Energy), as well as the many provincial experts who contributed to the development of this innovative and strategic tool for the clinical research sector.

Discover CTQ Sponsors today and advance your projects at the heart of Quebec’s clinical research ecosystem!

Good Clinical Practices – ICH E6(R3): Updates to Support the Evolution of Clinical Research

Clinical research is evolving rapidly, driven by new approaches, emerging technologies, and more flexible trial models. Revision 3 of the Good Clinical Practices (GCP) – ICH E6 fully aligns with this transformation. It provides a modernized, quality‑focused framework that supports more efficient trials while upholding the fundamental priorities: participant protection and data reliability. This revision will come into effect on April 1, 2026.

Revision 3 of ICH E6 marks an important shift toward a risk‑based quality approach. This orientation enables research to focus on what truly matters and reduce efforts on non‑critical aspects—without ever compromising safety or scientific integrity.

Several elements reinforce this vision:

• Validation of computerized systems.
• Qualification and oversight of subcontractors/service providers.
• Increased attention to data governance.

Although several changes specifically affect sponsors, sponsor‑investigators and research teams will see impacts on their day‑to‑day practices. Integrating new technologies, adapting to a risk‑based approach, and revising long‑established processes involve cultural, organizational, and training considerations for sites.

Finally, some elements of the guideline are not entirely new, but their importance has been clarified and further emphasized.

Public Consultation on Modernizing the Regulatory Framework for Clinical Trials

Participate in a new public consultation by Health Canada on modernizing the regulatory framework for clinical trial before April 19, 2026. This initiative aims to update regulatory requirements to better support innovation, transparency, and safety in the conduct of clinical trials in Canada.

• Modernizing the regulatory framework is essential to:
• Facilitate and accelerate Canadians' access to innovative treatments
• Drive innovation in the design and conduct of clinical trials
• Reduce the administrative burden for researchers and sponsors

Your voice matters! Researchers, health professionals, research ethics committees, patients, and citizens: help shape the future of clinical trials in Canada.

As a Program Lead at CATALIS, Maya embraces the organization’s mission to foster collaboration among key stakeholders in the life sciences sector (sites, CROs, sponsors) in order to accelerate the adoption of innovative therapies and improve patient access. She is committed to strengthening the attractiveness and efficiency of clinical research, particularly in Quebec.