Performing all of the literature research to prepare the Clinical Trial Application (CTA), right through to finding the most appropriate Clinical Research Organization (CRO), being your technical liaison with them, ensuring everything is done to Good Clinical Practices (GCP) and to submitting the final report to Health Canada.
Products include cannabis & extracts, drugs, and natural health products (NHPs)
Creating the Pre-Clinical Trial Application (pre-CTA) to Health Canada requirements:
- Research & compile all of the human clinical studies done to date for related health / medical conditions that employed the compound(s)
- Research the various previously approved clinical trial protocols for that condition, in order to develop one to submit to Health Canada specific to you our desired end points.
- Draft the pre-CTA package, taking into consideration the:
- scope of the clinical trials (i.e.: number of variables to evaluate)
- baseline levels of variables
- determination of Phase of clinical trial (I – IV)
- identification of target population
- number of patients required
- dosages & duration
- double blind, cross over vs. open label.
- Work with health care practitioners at the various clinics & hospitals, who would be participating in the CTs, including negotiation of ownership / proprietorship of data at various stages.
- Submit the pre-CTA package, which includes the:
- Negotiate the final clinical trial protocol with Health Canada
- Selection of indemnity insurance
Selection & working with the Clinical Research Organization (CRO):
- Randomization of the patients
- Amount of time and costs associated with each phase of the Trials
- Selection of patients
- Selection of Central Lab
- Selection of Principal Investigator (PI)
- Compliance to Research Ethics Board (REB) requirements
- Using our in-house developed auditing checklists, ensure all processes & documentation will be done according to Good Clinical Practices (GCP) guidelines as set out in the Health Canada, FDA, and ICH (International Committee on Harmonization) guidelines
- Collection of safety & efficacy data, including statistics
- Database management
- Compile the submission
Assistance with Obtaining Funding
We can also help identify sources of public and/or private funding to help offset the costs of these Clinical Trials, including Scientific Research & Experimental Development (SR&ED) input tax credit (ITC) program through Canada Revenue Agency (CRA).
Why use a consultant?
Weighing the numerous pros & cons of bringing in a consultant vs. tackling it all in-house? Please see our web page “Why Use a Consultant” as part of that critical thinking process. Based in British Columbia, but covering all of Western Canada.