Clinical Trial Management and Performance Metrics
We can step in to manage your trial toward your quality, timeline and cost objectives. We can also coach your staff towards achieving your project objectives.
We can help you develop appropriate, easy-to-manage, meaningful metrics that will provide an overall management view and a detailed view to identify project problems before they escalate.
Data Collection and Expedient Trial Close-Out
We can advise on best data collection methods, from traditional paper-based processes to fully electronic trial management with remote data entry. We can help you through the maze of offerings, to find the solution that best fits your project objectives and budgets.
Sponsor and Investigational Staff Training
We have extensive experience in assessing investigator and sponsor staff skill levels. We know how to develop and conduct appropriate training for adult learners in clinical trial conduct, ICH-GCP, clinical trial management, as well as team and staff management.
We can provide on-site monitoring resources in Canada and the U.S. through a network of regionally based monitors. If required, through our experience we can assist in the identification, assessment and selection of CROs in other jurisdictions.
Our extensive knowledge of regulations on adverse events in the United States, Canada and Europe enables us to plan and implement your adverse event management for clinical trial and marketed products. Our Safety Team are supported by the validated Clinical Safety Database PcVmanager by Extedo, a drug safety management solution based on the E2B and MedDRA industry data standards.