The CTSU Advantage

Clinical Trial research is a complex process requiring stringent compliance to ethical and regulatory standards.  The Clinical Trial Landscape is ever evolving to develop efficient trials, reduce turnaround times, and improve patient safety. The CTSU is dedicated towards keeping abreast with the changing landscape.  We offer our researchers with Clinical Trial management services, thus optimizing time and resources towards clinical and patient management functions of the trial.  As a patient-centric entity, we offer the following CTSU Advantages:   

• Regulatory compliance encompassing regulatory agencies such as Health Canada and US FDA  
• Strict adherence to principles of ICH-GCP and TCPS2 throughout the conduct of the trial  
• 100% N2SOP trained and compliant CTSU staff  
• Cross functional experience managing variety of clinical trial sponsors, investigators, and therapeutic areas  
• Standardized internal process, geared towards operational excellence to improve quality and meet sponsor and investigator expectations  
• Experience ability to work across multiple studies and manage steep timelines  
• Support with managing project finance and invoicing  
• Specialist Legal Counsel services for execution of necessary legal documentation such as but not limited to NDA, CDA, MOU, LOI, and CTA as per required jurisdiction, provincial and federal law as applicable to industry and academia  
• Specialist CTSU staff, well versed with tri-agency funding to facilitate appropriate budget negotiations for agency funded vs industry funded studies