Phase IV Clinical Trials

A Phase IV Clinical Trial, Also Referred To As Post-Marketing Surveillance, Or As A Post-Approval Study, Is Conducted After A Product Has Gained Regulatory Approval

The main objectives of a phase IV clinical trial are to gain additional safety information such as side effects, information on metabolism, and mechanism of action. These trials allow for the product to be studied in a real-world population. Phase IV trials can also have shorter timelines because they are exempted from CTA filing, however, REB approval is still required, GCPs must be observed, and record-keeping is crucial to success.

dicentra can assist in ensuring you have the right record-keeping and documentation ready for your Phase IV trial, as well as protocol design, and trial management, data analysis, and reporting.

Contact dicentra today to learn how we can help you fulfill your Phase IV clinical research needs