Clinical Trials Management
With over 20 years of experience in clinical trial operations for Phase II/III/IV, registry, and investigator initiated studies, the CVC clinical trials team has the expertise and knowledge to deliver a high quality and well executed trial from study start-up to closeout. Having worked with over 530 site investigators, representing more than 275 institutions across Canada and internationally, our team understands the sites’ capabilities, and has built and maintained ongoing collaborations with them. This understanding enables us to approach the best sites who can deliver the right patients for the study. As an academic research organization, all of the CVC’s clinical trials include the involvement of at least one of our faculty members who are practicing physicians that can relate to the role of the investigator and site.
Led by our associate director of clinical trials, we have a very experienced, diverse, and knowledgeable team comprised of clinical trial project leads, regulatory specialists, a monitoring lead, regionally based monitors, and administrative support. Our team works hard to build and maintain strong relationships with our sites, sponsors, and partners to deliver efficient, cost-effective, and high-quality clinical trials. We attribute our success managing clinical trials to the hands on, collaborative team approach we provide to our sites, sponsors, and partners.
- Senior Project Management with Executive and Steering Committee Coordination and meeting planning
- Overall Project and Site Management throughout all phases of the study
- Site/Investigator selection and qualification
- Investigative site start-up and training
- Regulatory document collection, review, and tracking
- Data Collection and query resolution
- Health Canada regulatory submission
- Development and distribution of newsletters and trial related communications
- Investigator and Steering Committee meeting planning and coordination
- Negotiation and oversight of site contracts and payments
- Ongoing communication and collaboration with all trial related stakeholders