Clinical Trial Applications
Clinical Trial Applications - Getting Health Canada Authorization
With a 99% success rate, our team streamlines the Clinical Trial Applications (CTAs) process and increases the probability of a successful CTA authorization at Health Canada. At SPharm, we:
- provide guidance on regulatory requirements,
- develop short and long term strategies with market access in mind,
- provide input in protocol preparation and study design,
- participate in preparation of Investigator’s Brochure (IB) & Inform Consent Form (ICF),
- prepare complete clinical trial applications,
- prepare eCTD or non-eCTD electronic-only publications, and secure submission,
- ensure study lifecycle management
The CTA Process: From Complex to Streamlined
As Regulatory Affairs experts, SPharm is ideally suited to handle the Clinical Trial Application process required by Health Canada. The global development process can be both lengthy and complex because it involves rigorous research & key document preparation (Ex. Protocol, IB & ICF) and reviews. It also requires rigorous regulatory submission preparation and submission to regulatory authorities completed by scrutinized review by authorities to ensure that the proposed trial meets ethical and scientific standards and poses minimal risks to participants.
However, the regulatory process can be relatively straight forward, less timely and costly if you are working with a competent and experienced partner like SPharm. For instance, when all documents are in hand:
- The process can take as little as 2 weeks to prepare a dossier for submission
- It will take Health Canada as little as 30 days to review (target review)
- We can respond to any questions from Health Canada in as little as 2 days
Successful Clinical Trial Applications require:
Meeting Local Regulatory Requirements
A thorough understanding of the regulatory requirements specific to the country or region where you plan to conduct the clinical trial. This includes applicable laws and regulations, and ethical considerations.
Detailed & Complete Study Protocol
A well-designed study protocol is essential for a successful CTA application or equivalent outside Canada. This protocol should include a clear description of the study objectives, the study population, the treatment, or intervention being tested, and the methods of data collection and analysis.
Safety & Efficacy
Detailed safety and efficacy data gathered to date and measures and demonstration that the potential for the treatment or intervention is effective; safety and efficacy are the most critical considerations for any clinical trial.
Complete & Comprehensive
Be complete, comprehensive and follow local regulations and application guidelines carefully to ensure that all required information is included (e.g.: the study protocol, investigator’s brochure, informed consent forms, and all other information relevant to the trial application).
The CTA application process can involve multiple rounds of guidance, review and revision requiring patience and perseverance.
SPharm is trusted by companies globally to drive the CTA process from start to authorizaton and regulatory lifecycle management of the study.
Clinical Trial Applications in Canada
The regulatory authority (the Minister) must be provided with a CTA in Canada and, a 30-day review period must be completed or an authorization received to proceed before the start of any human clinical study or trial for all novel medications (drug, biologic or radiopharmaceutical). In addition to the previous requirement, for each clinical trial site, the sponsor need to obtain the approval of the research ethics board in respect of the protocol and ICF per Food and Drug Regulations. Other requirements apply.
The equivalent would be submitted to the Food and Drug Administration (FDA) in the United States as an Investigational New Drug (IND) submission, likewise in Europe through a Clinical Trial Authorization (CTA), to name only those. Other regulatory agencies have similar processes.
What is the Clinical Trial Applications process in Canada?
The Canadian Clinical Trial Application dossier consists of the following documents (exceptions and variations are possible):
- administrative form,
- protocol,
- protocol summary (Health Canada’s template),
- Informed Consent Form,
- Investigator’s Brochure and,
- Quality dossier summary (Health Canada’s template per study phase)
Health Canada reviews the CTA and notifies the sponsor within 30 calendar days from the date that the application is considered complete. Questions may be issued during the review, and the sponsor will have 2 calendar days to provide the response (exceptions can apply). Note that CTAs are required for phases I to III clinical trials. It is recommended to wait for the authorization (No Objection Letter) prior to initiating the trial and importing the investigational product(s) in Canada.
If Health Canada provides authorization, the study can be underway with human subjects that are informed and have given their consent to be administered the drug for their participation. Note that a Canadian Ethic Committee must also approve the study material. Tests are conducted in a controlled environment where drug administration procedures and results are closely tracked, monitored and analyzed.
Please review our guide on the regulatory process in Canada for further insight into the requirements.
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