Clinical Trials Management
With over 20 years of experience in Clinical Trial Operations for Phase II/III/IV and investigator initiated studies, our team brings the expertise and knowledge to deliver a high quality and well executed trial from study start-up to closeout. Having worked with over 460 Canadian Site Investigators which are representative of more than 230 institutions across Canada, we not only understand their capabilities but have also developed ongoing collaborations and relationships with them. This understanding enables us to approach the right sites who can deliver the right patients for the study. As an academic research organization, all of our clinical trials include the involvement of at least one of our faculty members who are practicing physicians and are able to relate to the role of the investigator and site.
We have a very experienced, diverse, knowledgeable and personable clinical trials team comprised of Clinical Trial Project Leads, Regulatory Specialists, a Monitoring Lead, regionally based monitors, and administrative support. Responsible for ensuring all operational aspects of the study run smoothly, our Clinical Trial Project Leads and Regulatory Specialists work closely with our sites to strive for quick and efficient start-up, high recruitment and retention of patients that meet the study criteria, data entry that is accurate and well maintained, and delivery on timelines as laid out from study start-up to study completion. As the primary contact for the Canadian sites, the Clinical Trial Project Leads have their fingers on the pulse of all aspects of the trial, which enables them to maintain a good understanding of the overall functioning of the study, while closely monitoring trends and issues across Canada.
Our clinical trials 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. In addition to the relationships we have built, we also attribute our success in the management of 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