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
Monitoring
Data management
Biostatistics

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
Meta-analyses
Statistical programming

Access our services

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

Useful links

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.