Clinical Trial Management
McConnell Centre for Innovative Medicine, RI-MUHC
We provide clinical trials expertise and study management services to clinicians and industry partners to facilitate the highest quality of clinical research. Our expertise covers clinical trial phases I to IV and registry studies.
Project management services for clinical research
Our experienced and highly qualified project managers ensure that studies are efficiently conducted with precise objectives, timelines and outcomes. They see that studies are conducted on time, within budget, and in accordance with all relevant regulatory guidelines. They can assist with:
- Submissions to Health Canada
- Feasibility studies
- Site and investigator selection
- Contract and budget negotiations
- Meeting planning and logistics
- Leading the study team and providing support
- Managing internal stakeholders (i.e., data management, ethics board, contracts)
- Liaising with principal investigators, industry and other sponsors, study sites and investigators
- Oversight of monitors and project coordinators
- Submission to Research Ethics Board (REB) of the McGill University Health Centre (MUHC)
Monitoring services for clinical research
At the McConnell Centre for Innovative Medicine, our highly trained and qualified study monitors ensure the quality of the data collected and safety of the patients. Based on protocols, ICH Guidelines for Good Clinical Practice (GCP), standard operating procedures (SOPs), and applicable regulatory requirements, our study monitors support clinical research by
- monitoring visits, including evaluation, initiation, routine monitoring, close-out and remote monitoring visits,
- writing of monitoring visit reports and associated logs, and
- acting as the main contact between the study sponsor and the clinical research site.
Data management services for clinical research
The data management team at the McConnell Centre for Innovative Medicine is expert in selection of the best data collection tools within the budget and timeline. The remote electronic data capture (REDCap) database is validated with full audit trail and meets industry standards. REDCap has been placed in an environment compliant with the FDA 21 CFR Part 11.
Data management team members are dedicated to your project from start-up to database lock. Services include:
- Data management and validation plan development
- Design of Case Report Forms (CRF)
- Management of data clarification forms (DCF) with investigative sites
- Electronic data capture (EDC) migration technical support
- Data transfers
- Laboratory data imports
- Development and review of standard operating procedures (SOPs) for data management
- Pre-FDA auditing
- EDC, paper and hybrid systems and processes
- EDC training for sites and project teams, as well as EDC help desk services.
Biostatistics services for clinical research
Biostatisticians and statistical programmers lead the design and analysis of phase I-IV clinical trials and health surveys at the McConnell Centre for Innovative Medicine. All of our biometrics systems are validated with full audit trail.
Our services include:
- Protocol design
- Statistical analysis plan development
- Confirmatory and exploratory analyses
- Statistical results interpretation and presentation
- Statistical analyses for manuscripts and publications
- Customized statistical reports
- Pooled analyses
- Statistical programming
Read more about the RI-MUHC Biostatistics Consulting Unit
Access our services
Contact us to discuss your needs in clinical trial management. We welcome your inquiries!
Monday to Friday, 8:30 a.m. to 4:30 p.m.
514-934-1934 x 27346
McConnell Centre for Innovative Medicine (CIM)
Research Institute of the McGill University Health Centre (RI-MUHC), Glen site
1001 Decarie Boulevard
Montreal, Quebec, CANADA H4A 3J1
Clinical research platforms provide access to state-of-the-art technology, equipment and facilities for clinical research, within an ultramodern hospital environment. Our clinical research platforms include a cardiopulmonary functional testing platform, medical imaging, biobanking, an experimental operating room, and more.
Our experts work on novel therapeutics, treatments, interventions and clinical trials in most major areas of health research, including infection and immunity, health outcomes, human reproduction and development, respiratory health, neuroscience, mental illness and addiction, cancer, cardiovascular diseases, endocrinology, diabetes, kidney diseases, and hormone-related cancers.
Information for patients interesting in participating in clinical trials
Information for industry interested in partnering with the Research Institute of the McGill University Health Centre
Centre for Applied Ethics at the McGill University Health Centre
Overview of clinical research at the Research Institute of the McGill University Health Centre
About the McConnell Centre for Innovative Medicine
Clinicians and clinician-scientists at the Research Institute of the MUHC (RI-MUHC) benefit from one of the most modern clinical research facilities in North America. The McConnell Centre for Innovative Medicine (CIM) offers a full range of clinical research services in a state-of-the-art environment dedicated to clinical research, with access to services for clinical trials management, quality and monitoring, as well as highly trained personnel and specialized equipment dedicated solely to clinical research.