Protocol Review

A Protocol Review By dicentra Involves An Assessment Of Your Study Protocol Or Clinical Trial Application To Determine Its Overall Fitness Prior To Submission

Clinical Trial Applications (CTAs) and CTA amendments are subject to a 30-day default review period for pharmaceuticals and a 90-day review period for NHPs, wherein the final study protocol must be submitted.

Study protocols must follow the Good Clinical Practices outlined in the guidance document International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) in E6(R2): Good Clinical Practice. Failure to adhere to these GCP’s can lead to a Not Satisfactory Notice issuance in response to your CTA by Health Canada.

dicentra’s interdisciplinary team is in place to assist you in gaining a No Objection Letter issuance by reviewing your protocol in depth.

Contact us to review your clinical trial protocol.