TIP-13. Advancing Patient-Centered Neurological Trials in Canada through Scientific Innovation and Operational Excellence at The Clinical Research Unit at The Montreal Neurological Institute and Hospital

Abstract The Clinical Research Unit (CRU) at the Montreal Neurological Institute-Hospital (MNI) represents Canada’s most comprehensive academic center for neurological clinical trials, offering industry partners unmatched scientific capabilities and operational efficiencies. With 40 years of experience, the CRU currently manages 115+ active trials across all phases (I-IV), including 12 gene therapy trials and 18 studies in rare neurological diseases. BACKGROUND Our center provides direct access to specialized patient populations (35000+ MNI outpatients) through dedicated clinics serving 1100+ participants annually, including the largest brain tumour clinic in Quebec (2000+ patients, 350+ new cases/year). METHODS Our infrastructure includes Canada’s only 7T MRI dedicated to clinical trials, a 3T MRI, high-resolution PET and micro-PET, a cyclotron, MEG, real-time EEG, a GMP-certified clean room for cell and gene therapies, interventional radiology expertise, dedicated lab infrastructure for clinical trials, and Phase I overnight facilities. The CRU team includes 50 full-time staff: ICU-trained nurses, 20 certified research coordinators, and dedicated ethics, finance, and pharmacy professionals. The CRU is known for its expertise in rare diseases and is home to a first-of-its-kind Phase 1 Unit dedicated to neurological disorders. Operational metrics demonstrate our efficiency thanks to a Neuro-specialized Review Ethics Board, CTMS-enabled operations, membership of Catalis, Quebec’s Fast Track Network (reducing ethics approval timelines by 60%). Moreover, conducting both industry-sponsored and investigator-initiated trials, with a high patient retention rate. CONCLUSIONS With 15 active industry partnerships and 5 ongoing open science collaborations, the CRU has contributed to 7 FDA/Health Canada approvals since 2018. For sponsors seeking excellence in CNS trials, we offer: (1) Canada’s largest neuroscience patient population with deep phenotyping data, (2) specialized infrastructure for advanced therapies, (3) specialized personnel and infrastructure, and (4) world-leading clinician-scientists with academic leadership in trial design. Our track record makes us the ideal partner for innovative neurological drug development.