Clinical Trial Services
We offer a full suite of pre- and post-market clinical trial services designed to accelerate phase I-IV trials. From study start-up to commercialization, our goal is to ensure trials are conducted efficiently, completed on time and within budget, all while maintaining the highest quality and ethical standards.
For industry sponsors seeking a full-service approach, our Clinical Trial Concierge acts as a central point-of-contact, helping engage with the University research ecosystem and connect to the right resources at the right time.
Support at every stage
Our extensive network of research support offices provides expert guidance and services at every stage of the clinical trial lifecycle. From concept development and start-up support to study closure and knowledge translation, our experienced professionals provide services that address the operational, regulatory and clinical challenges involved in research.
- Dedicated labs and facilities
- Recruitment channels able to access a diverse patient population
- Pharmacokinetic expertise
- Data and analytics solutions
- Research expertise and clinical experience across a range of therapeutic areas
- Ability to recruit from an engaged, diverse patient population
- Extensive data management solutions
- Operational, biostatistical and regulatory guidance
- Regulatory support (extensive experience working with Health Canada, the FDA and the European Drug Agency)
- Dedicated labs and facilities (including outpatient facilities, medical imaging centres, a research pharmacy with investigational drug storage capabilities, and more)
- Experienced research personnel
- Internationally recognized researchers across most therapeutic areas
- Strong data, analytic and IT solutions
- Pre- and post-market solutions
- Regulatory guidance and submission support
- Experience working with Health Canada, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA)
- For life sciences and health technology startups: entrepreneurial and business development programming, mentorship, and connections to local experts, facilities and resources.
Clinical Trial Services
We offer the full-service capabilities of an Academic Research Organization (ARO) paired with extensive innovation and entrepreneurial expertise. Support services are delivered by our network of administrative and operational teams.
Services are available in the following areas:
Providing scientific, medical and operational advice to ensure the success of your trial. This includes:
- Budget development support
- Feasibility assessment
- Regulatory consulting and document management (including access to TRACR Platform)
- Data management (including database design, development and validation)
- Protocol development
Providing operational guidance and services to ensure efficient study start-up:
- Site selection and coordination
- Investigator selection and liaison
- Participant recruitment
- Database design
- Logistical consultation
- Contract facilitation and approvals
Ensuring the successful execution of your study, while maintaining the highest ethical and regulatory standards.
- Access to an experienced research workforce
- Participant engagement
- Data collection and management
- Project management
- Protocol governance
- Financial operations
- Event tracking and reporting
- Investigational product storage and distribution
Post-study solutions that aid in data analysis, analytics and knowledge translation:
- Data validation
- For medical devices and technology – usability testing, users centric design and user interface analysis
- Data interpretation
- Knowledge transfer and dissemination
Clinical Trial Concierge
Acting as a central point-of-contact, our Clinical Trial Concierge helps sponsors navigate and engage with the research ecosystem at the University of Calgary. The Concierge can:
- Help interested parties connect to the resources, services and personnel required to move their research forward.
- Develop a personalized project-specific plan to help address administrative and regulatory challenges.
- Assist with identifying and connecting with investigators, facilities and recruitment channels.
- Facilitate the execution of all startup activities, contract reviews, budget negotiations and ethics/regulatory approvals.
- Foster relationships with academic and business units.
- Serve as a personalized consultant that coordinates the operational requirements of trials so you can focus on what’s most important – your research.
If you'd like to connect with our Clinical Trial Concierge, contact us.