CATALIS Celebrates Four Years of Success With the FAST TRACK Evaluation Service 🎉 | CATALIS is proud to celebrate four years of success for the FAST TRACK Evaluation Service, which continues to demonstrate its effectiveness in optimizing administrative processes in clinical research in Quebec. Since the launch of the pilot project in 2021, 216 evaluation requests have been processed by the CATALIS Central Office and then evaluated by participating healthcare institutions. To date, and thanks to the collective efforts of all stakeholders, the Service's performance is ~70% faster than typical median times. - Scientific, ethical, and contractual approvals are obtained in a median time of 7 weeks.
- Institutional authorizations are obtained in a median time of 10 weeks, which includes all project evaluations: scientific, ethical, contractual, pharmacy, imaging, laboratory, and other required local conveniences.
- Site activation is completed in 13 weeks, which corresponds to the total median time elapsed between receipt of study materials for evaluation and site activation by the sponsor.
In 2024-2025, the FAST TRACK Evaluation Service processed 11% of pharmaceutical clinical trials submitted in Quebec, and our projections indicate that this volume will double in 2025-2026. An Effective Ethical Review Process While several pan-Canadian stakeholders express concerns about the cumbersome nature of ethical evaluation processes, Quebec stands out for the remarkable efficiency of its research ethics boards (REBs) within the service framework. As early as 2021, public-private members of the CATALIS Network reviewed processes to ensure the quality of project submissions and optimize exchanges with REBs. Combined with the provincial multicenter ethics mechanism, these adjustments, made both upstream and downstream of ethical evaluation, have significantly reduced REB approval times. This performance is all the more notable as REB evaluations in Quebec cover several dimensions: scientific evaluation, overall project ethics, as well as local ethics related to its implementation. They include verification of recruitment methods, consent processes, conflicts of interest, compliance with provincial laws and regulations, translation of materials for participants, administrative modifications to consent forms by sites, and consideration of institutional specificities. Through this rigorous and collaborative approach, the FAST TRACK Evaluation Service has demonstrated over four years its ability to concretely reduce clinical trial startup timelines, thus enabling healthcare institutions and sponsors to accelerate access to innovation, and allowing patients faster access to clinical trials in Quebec. | Bayer Liver Cancer Study: 3 Quebec Institutions Rank Among the Top 3 Worldwide | Thanks to the support of the FAST TRACK Evaluation Service, three Quebec hospital research centers were positioned at the very top globally for the speed of implementation of a Phase I clinical study conducted by Bayer on hepatocellular carcinoma. The Centre hospitalier de l’Université de Montréal (CHUM), with Dr. Daniel Juneau, was the first site activated worldwide from among 24 sites in 22 countries. The Centre hospitalier universitaire de Sherbrooke (CHUS), with Dr. Frédéric Lemay, ranked second of all sites activated in the world. The McGill University Health Centre (MUHC), with Dr. Victoria Mandilaras, was the third site activated, and it recruited the first patient worldwide. | “Bayer Canada is pleased to announce the FAST TRACKED activation of three BANTAM-01 sites in Quebec, made possible by CATALIS Quebec’s FAST TRACK Evaluation Service and our exceptional Canadian study team. This partnership has significantly accelerated activation, allowing Quebec patients to become the first in the world to access this innovative treatment for hepatocellular carcinoma. This type of success further reinforces Canada’s attractiveness for global clinical trials and aligns well with Bayer’s commitment to advancing healthcare and improving patient outcomes globally.” - Alison Batty, Head Site Management in Canada, Bayer | | Montreal’s Jewish General Hospital Authorizes a Novartis Study on GEP-NETs in Only 8 Weeks and Becomes the Second Site Activated Worldwide | The Jewish General Hospital (JGH) in Montreal authorized Novartis’ NETTER-3 study in only 8 weeks with support from the FAST TRACK Evaluation Service. This fast timeline allowed the team led by Dr. Petr Kavan to position itself as the second site activated worldwide for this Phase III study on gastroenteropancreatic neuroendocrine tumors (GEP-NETs). | | | “As a partner of CATALIS, we are proud to offer the FAST TRACK Evaluation Service, which enables our patients to access the most promising treatments more quickly. This collaboration reflects our commitment to advancing cutting-edge clinical research that truly addresses the needs of the communities we serve.” - Dr. Sarit Assouline, Physician-Researcher, Head of the Division of Hematology, Jewish General Hospital (CIUSSS Centre-Ouest-de-l'Île-de-Montréal) | | | “We are proud that our site was among the first ones in the world to be activated for the NETTER-3 study. Through support from CATALIS and the FAST TRACK Evaluation Service, we were able to act quickly and provide our patients with access to an innovative treatment option that has the potential to truly improve their care.” - Petr Kavan MD, PhD, Researcher at the Institute and Associate Professor, Gerald Bronfman Department of Oncology, McGill University Faculty of Medicine and Health Sciences | | CATALIS Unveils Its Clinical Trials Quebec Training Program | Please note that all training modules and tools are currently available in French only. As part of our 2025–2026 action plan, CATALIS was tasked with promoting best practices in clinical research in Quebec by implementing a provincial training program for research professionals. On one hand, following recommendations from our network, we renewed our partnership with N2 Network of Networks to provide Quebec healthcare institutions with free access to pan-Canadian core training programs. In addition, we have also begun developing additional, more specialized training and tools to address the specific needs of Quebec. Over the past few weeks, we have been gradually rolling out the Clinical Trials Quebec (CTQ) training program and tools, designed to support and harmonize clinical research practices across the province. These trainings and tools aim to strengthen regulatory compliance and raise quality standards in clinical research. The following training modules and tools are currently available: We would like to warmly thank the public and private members of our Quality and Training Advisory Committee for their commitment and expertise in carrying out this provincial project. And this is just the beginning: additional complementary training is already in development to continue supporting best practices in clinical research! | CATALIS Honors Louise Proulx at the Conclusion of Her Term on the Board of Directors | CATALIS wishes to express its gratitude and acknowledge the end of Ms. Louise Proulx’s term as a member of the Board of Directors and Chair of the Audit and Risk Management Committee. | An active member of the Board since 2018, Ms. Proulx has played a key role in strengthening the organization’s strategic governance. Through her rigor, vision, and dedication, she has made an outstanding contribution to establishing CATALIS as a key player in Quebec’s clinical research ecosystem. | | A Message From Me Jean Groleau, Chair of the Board of Directors | "The Board of Directors has greatly benefited from Louise's commitment and strategic vision. She has made a remarkable contribution to the solid foundation on which CATALIS stands today." - Me Jean Groleau, Lawyer and co-founder, Groleau Gauthier Plante LLP | | The Board of Directors of CATALIS brings together experts from Quebec’s healthcare institutions, the pharmaceutical industry, and independent directors. Together, they ensure sound governance and guide CATALIS’ key priorities, in line with its mission to optimize the clinical research environment and accelerate the development of innovative treatments for patients in Quebec. Mr. Jean Groleau, Chair of the Board of Directors, along with all board members, wishes to sincerely thank Ms. Proulx for her exemplary leadership, generosity, and invaluable contribution to CATALIS’ mission. Her departure marks the conclusion of a mandate characterized by collaboration, excellence, and dedication, leaving a lasting impact on the organization’s governance. | The CATALIS Team Is Growing | Me Emily Kirby - Lawyer and Ethics Specialist Emily is a lawyer specializing in research ethics and governance. A member of the Quebec Bar since 2011, she holds a Bachelor of Civil Law (LL.B.), a bachelor’s degree in biology (B.Sc.), and a master’s degree in environmental studies (M.Env.). Before joining CATALIS, she worked for over 10 years within research projects and consortia in Canada and internationally, developing expertise in data governance, privacy and consent. As a lawyer and ethics specialist at CATALIS, Emily supports the organization in its legal and ethical affairs, notably by assisting the FAST TRACK Evaluation Service and advisory committees. | | Lyes Bilal Khelladi - Project Lead, FAST TRACK Evaluation Service With over 17 years of experience in the pharmaceutical industry, Lyes holds a Bachelor’s degree in Pharmacy and a Graduate Diploma (DESS) in Drug Development, Regulatory Affairs, from the Université de Montréal. He has held various positions in clinical research and developed recognized expertise in managing ethics submissions. As a Project Lead at CATALIS, he leverages his knowledge and professionalism to contribute to the development of the FAST TRACK Evaluation Service, which aims to accelerate access to innovative treatments for patients across Quebec. | | Marie-Ève Rego - Project Lead, FAST TRACK Evaluation Service Marie-Ève holds a Bachelor of Science in Nursing from the Université de Montréal and worked as a clinical nurse before specializing in clinical research. She has solid experience coordinating Phase I and II trials, including first-in-human studies. She then worked at Merck Canada and at the CHUM Research Centre, where she developed expertise in regulatory and ethics submissions. At CATALIS, Marie-Ève draws on her clinical and regulatory experience to help advance the FAST TRACK Evaluation Service, facilitating faster access to innovative treatments for patients in Quebec. | | Laurence Brière - Project Lead, FAST TRACK Evaluation Service Laurence holds a Bachelor’s degree in Biopharmaceutical Sciences, as well as a graduate diploma (DESS) and a Master’s degree in Drug Development from the Université de Montréal. She began her career at Novartis Canada in 2019, where she quickly progressed into roles focused on clinical trial coordination and study start-up. Now a Project Lead at CATALIS, Laurence contributes to the development of the FAST TRACK Evaluation Service, helping to improve access to innovative treatments for patients in Quebec. | | Aurélie Garrone - Patient and Healthcare Professional Service Agent Aurélie holds a Bachelor’s degree in Behavioral Neuroscience from Concordia University. She began her career supporting individuals with disabilities before turning to clinical research. She notably worked as a research assistant on two major aging cohorts: the CLSA at the MUHC and PREVENT-ALZHEIMER at the Douglas Institute. As a Patient and Healthcare Professional Service Agent at CATALIS, Aurélie applies her background in both intervention and research to provide personalized and compassionate support. | | CATALIS Quebec is a non-profit partnership dedicated to operational excellence in clinical research in Quebec, and since 2017, it has been carrying out a government mandate to optimize the clinical research environment in the province. Clinical Trials Quebec, powered by CATALIS Quebec, provides comprehensive and accessible information about clinical research and promotes access to clinical trials for Quebecers. | Discover Our Tools and Services: | Follow us on LinkedIn to learn why Quebec is a world leader in clinical trials. | | | | |