You have probably heard of the terms IND and NDA being used during drug development and applications. People tend to get confused between the two terms and wonder how they […] Read More >>
During the pandemic of respiratory disease caused by a novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or Coronavirus Disease 2019 (COVID-19), the FDA Commissioner may authorize the use […] Read More >>
COVID-19 tests are considered medical devices and are regulated under the Medical Devices Regulations in Canada. Medical devices are classified into 4 classes: Class I are those with the lowest […] Read More >>
Clinical research in Canada has seen a significant uptick in interest from Sponsors and Investigators since the onset of the COVID-19 pandemic. This interest is perhaps a precipitate of increasing […] Read More >>
A clinical trial protocol is a document that is designed to outline all details of a clinical trial. It is the main document referred to throughout the trial lifecycle and […] Read More >>
In May of 2021, Health Canada announced a proposal to modernize the regulatory framework for Clinical Trials. This proposal hopes to help improve support the introduction of novel safe and […] Read More >>
Back in the 1960s a revolutionary breakthrough in x-ray technology lead to the invention of the dual-energy x-ray absorptiometry (DXA) machine. This new technology, introduced by Dr. Richard Cameron and […] Read More >>
Clinical trials proceed with four phases to assess the safety and efficacy of an Investigational Product (IP) [1]. The sample size should be considered with extra care for each of […] Read More >>
Recruitment is a crucial part of the Clinical Study workload. Even if no clinical trial is actively searching for subjects, recruitment is an ongoing process in order to build a […] Read More >>
Put yourself in the shoes of the consumer for a minute…okay…ready? You walk into a health food store to purchase supplements that you recently learned about that you hope might […] Read More >>
In addition to governing pharmaceutical and medical device research, Health Canada provides oversight and approval of nutraceutical clinical research and natural health products conducted in Canada. This integrated approach allows […] Read More >>
Clinical trials can be overwhelming for many in the industry as they can be complex, long, and costly. However, smaller companies can conduct small well-designed trials (open label, or pilot study […] Read More >>
What are Clinical Trials? Clinical trials are a type of biomedical research that is conducted to help doctors and researchers learn more about health, diseases, and effective treatments in order […] Read More >>