Roche Pharmaceutical Company’s First Clinical Trial Approved Through CATALIS Quebec’s FAST TRACK Evaluation Service


Thanks to CATALIS’ FAST TRACK evaluation service, Roche’s ProHer multi-centre study, which explores a new treatment method for patients with breast cancer, was approved in 10 weeks by the CHU de Québec-Université Laval. More specifically, this study seeks to discover patients’ preference for at-home administration of a fixed-dose combination of Pertuzumab and Trastuzumab for subcutaneous administrate at the early or locally advanced/inflammatory stage.

“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


Another Success for the CHU de Québec-Université Laval


With the acceleration of this Roche study’s evaluation process, the CHU de Québec-Université Laval has ranked first among all the launched sites in the world, out of a total of 65 sites in 17 countries across the globe. This isn’t the CHU de Québec-Université Laval’s first successful experience with the FAST TRACK evaluation service. In September 2021, the CHU participated in the FAST TRACK evaluation service’s first-ever multi-centre study, in which it successfully enrolled the world’s first patient, ahead of more than 1,000 sites in 40 countries. More recently, it found itself holding the title of the world’s first launched site – for the third consecutive time – with the Sanofi Phase I – II study on advanced solid tumours.


“The FAST TRACK evaluation service has allowed us to increase private promoters’ power of attraction and launch projects in no time. Rapidly getting approval to launch Roche’s ProHer study and Sanofi’s Phase I – II study will allow the researchers, namely Dr. Lemieux and her team, to begin recruiting and, above all, to offer the drug to users quickly.” – Serge Rivest, director of the CHU de Québec-Université Laval’s research centre 




“We are happy to have participated in the pilot of CATALIS’ service and to have had the opportunity to positively contribute to the FAST TRACK evaluation process. We slightly exceeded the 8-week target, but that didn’t prevent us from being the first site in the world to launch. We are finalizing our local trajectories and actively seeking our first participant!” – Dr. Julie Lemieux, a researcher at the CHU de Québec-Université Laval’s research centre



“The FAST TRACK evaluation service’s implementation serves to optimize the launch timeframe of clinical trials. Launching a research project in an institution requires coordination between several partners and processes, both ethical and administrative. This coordination process is performed by the CHU de Québec’s research ethics office. Accelerated evaluation is made possible through collaboration between the research ethics board, research teams, and departments. CATALIS has made a point of involving stakeholders in developing a model that facilitates this acceleration while following the necessary steps and respecting the process’ thorough nature.” – Isabelle Jacques, assistant to the evaluation and ethics director in the department of quality, evaluation, ethics, and institutional affairs at the CHU de Québec-Université Laval’s research centre


Accelerating the Launch of Clinical Trials for the Well-Being of Patients


With its FAST TRACK evaluation service, which aims to significantly reduce clinical trial  authorization times, CATALIS and its network hope to increase Quebec’s impact in  clinical research and improve patients’ lives.  For example, accelerating the launch of the Roche study, which is investigating a new treatment method, could allow breast cancer patients to access potential innovative and effective treatments more quickly. 

“Clinical research in breast cancer can help us defy some statistics. More specifically, it offers patients hope they may benefit from potential innovative care, while also improving medical practices and generating significant economic benefits locally. This is why the Quebec Breast Cancer Foundation has always encouraged this type of research: to support our life sciences ecosystem. With CATALIS’ FAST TRACK evaluation service, the Foundation hopes that more Quebec women will quickly have access to these clinical trials, right here at home.” – Karine-Iseult Ippersiel, President and CEO, Quebec Breast Cancer Foundation

CATALIS Quebec’s management is delighted about its most recent success with the Roche pharmaceutical company and is especially proud to see that FAST TRACK evaluation service’s offerings seem to be well-received by the institutions and pharmaceutical partners that have participated in the pilot projects over the past few months.


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