The CATALIS Network’s new FAST TRACK Evaluation Service aims to authorize clinical trials in 8 weeks, a reduction of nearly 75% of the global standard authorization time.
Through the FAST TRACK Evaluation Service, CATALIS hopes to contribute to the optimization of the clinical research environment in Quebec and to the acceleration of the development of innovative treatments, for the benefit of patients.
Since the end of the pilot of the FAST TRACK Evaluation Service, CATALIS continues the launch of this Service with the pharmaceutical companies in its Network and the 15 participating healthcare institutions.
17 Clinical Trials Activated To Date
Study | Field | Phase | FAST TRACK Sites | Authorization Times | Global positioning | # Sites | # Countries |
Cardiology | III | 5 | 7.7 weeks 8 weeks 8.7 weeks 9.9 weeks 10.6 weeks | 1st site activated worldwide 2nd site activated worldwide 3rd site activated worldwide & 1st patient enrolled worldwide 5th site activated worldwide | 1000 | 40 | |
Adolescents MS | III | 2 | 7 weeks 6.1 weeks | 1st site activated in Canada | 90 | 30 | |
Advanced solid tumours | I | 1 | 7.1 weeks | 1st site activated worldwide & 1st patient enrolled in Canada | 5 | 3 | |
Advanced solid tumours | I/II | 1 | 16.1 weeks | Regulatory delay 1st site activated worldwide & 1st patient enrolled in Canada | 12 | 5 | |
Arthritis | II | 1 | 9.1 weeks | Ongoing study | 110 | 15 | |
Breast cancer | IIIb | 2 | 10.6 weeks 25 weeks | 1st site activated worldwide | 50 | 15 | |
Auto-immune diseases | III | 2 | 8.6 weeks 14.3 weeks | 1st patient enrolled in Canada | 195 | 30 | |
EFC15951 | Myeloma | III | 2 | 19.1 weeks 21.9 weeks | Canadian regulatory delay 1st & 2nd sites activated in Canada | 120 | 21 |
PKM16982 | Urticaria | III | 1 | 8.4 weeks | 2nd site activated in Canada | 15 | 13 |
Rare disease | II | 1 | 8 weeks | 1st site activated in Canada | 20 | 10 | |
Spinal muscular atrophy | II | 1 | 12.1 weeks | 1st site activated worldwide & 2nd patient enrolled worldwide | 15 | 10 | |
SIRIUS-SLE1 | Lupus | III | 1 | 7 weeks | 1st site activated in Canada & 1st patient enrolled in Canada | 120 | 20 |
1366-0031 | Scleroderma | II | 1 | 8.5 weeks | 165 | 30 | |
KRAS | Lung cancer | III | 3 | 8.6 weeks 11.6 weeks 1 site in progress | 1st & 2nd sites activated in Canada | 210 | 41 |
ACT17746 | Ulcerative colitis | II | 2 | 15 weeks 16 weeks | 1st site activated in Canada | 84 | 12 |
Inavo-121 | Breast cancer | III | 3 | 13.4 weeks 2 sites in progress | 155 | 19 | |
VICTORION-2 | Cardiology | III | 2 | 6.2 weeks 12.8 weeks | 1st public site activated in Canada | 1100 | 45 |
CATALIS Network Reacts to the Success of the FAST TRACK Evaluation Service
“The FAST TRACK evaluation service’s first pilot project is a tangible benefit resulting from our life sciences-focused efforts and our government’s strategy to attract more clinical trials and private investment to Quebec. The CATALIS Network proves that it is possible to be innovative in a highly competitive international environment. We are proud to support its efforts to position Quebec on the world stage of clinical research. It’s thanks to the collaboration of our researchers that our life sciences sector is performing well and achieving scientific breakthroughs that are transforming the lives of the Quebec population. CATALIS is one of the organizations that have made this success possible by making clinical research in Quebec more effective.” – Pierre Fitzgibbon, Minister of the Economy, Innovation and Energy, Minister responsible for Regional Economic Development and Minister responsible for the Metropolis and the Montreal Region
“I’m very impressed with Quebec’s determination to drive change and accelerate clinical research for those living with rare diseases. The Quebec policy on rare diseases reinforces the importance of speed and effectiveness of clinical trials to address the urgent need for patients to have access to potentially lifesaving treatments. Our collective efforts must strive to include access to these innovative treatments at time of Health Canada approval. I’m thrilled to continue working with CATALIS to focus our efforts on breaking barriers to advance research that can positively impact the lives of patients and their families.” – Andrea Marazzi, Novartis Canada Country President
“The FAST TRACK process in Quebec has demonstrated a strong commitment to revolutionize the clinical trial start up process with the aim to accelerate clinical development and expedite access to innovative medicines for patients. Boehringer Ingelheim Canada Ltd. is excited to see the success of the Quebec-based FAST TRACK service, which is an important collaboration endeavor that places the province in a favorable position globally to attract clinical research, and especially early clinical research.” – Gabriel Kim, Vice President, medical and regulatory affairs, BI Canada Ltd
“I was thrilled to learn that we were able to significantly reduce the ProHer multi-centre study’s authorization time thanks to CATALIS’ FAST TRACK evaluation service. In a world where patient recruitment is competitive, the opportunity to join forces with our institutions to speed up our timeframes means that Canadian patients have the opportunity to access innovative treatments through our clinical trials. We are working to achieve better outcomes for even more patients, and the FAST TRACK evaluation service is an essential component which allows us to fulfill our organization’s ambition.” – Christina Archer, Former Clinical Operations Portfolio Leader, Hoffmann-La-Roche
“Our first experience with CATALIS’ FAST TRACK evaluation service was a huge success. For a Phase I trial in oncology, we reduced our average launch time by two-thirds and attained two global ‘firsts’: the first site to be launched and the first preselected patient! We look forward to future victories and even faster launches with CATALIS.” – Stéphanie Veyrun-Manetti, Sanofi Canada General Manager, Specialty Care and Country Lead, Canada
The Participating Healthcare Institutions
If you are a pharmaceutical company and are interested in learning more about this service, please write to us at: info@catalisquebec.com.