When a drug is ready to be widely distributed, GVP and GCP inspections are necessary steps to take beforehand. GVP inspections are done for any establishment selling or importing a drug after its approval, while GCP inspections are undertaken during clinical trials. Such inspections are meant to ensure these trials are compliant with regulations, the establishments are reporting any adverse reactions to the drug(s), and that integrity and quality control standards are met. Short for Good Pharmacovigilance Practice and Good Clinical Practice respectively, these inspections are also completed to make sure all participants will be safe during the trials. Here’s.. READ MORE »
For any drug to be deemed safe for public consumption, it must first go through a life cycle of development. In Canada, this process is heavily regulated by the federal government, and must adhere to the guidelines of the Canadian Drug Review and Approval Process. Before any drug can be submitted to Health Canada for approval, it must undergo a series of phases, from preliminary research all the way to clinical trials. But what exactly do these processes for verifying a drug’s safety and efficacy involve? And why is each step necessary? Here’s what those seeking clinical research careers should.. READ MORE »
Clinical trials are essential for the development of new treatments. With this in mind, it becomes even more important to make sure sensitive data is protected in the process. This is especially true when these trials rely increasingly on digital file storage. Volunteers in these trials trust researchers’ ability to keep their data safe and secure, as well as protect their privacy. This can help prevent avoidable issues from occurring at any phase in the process, and reassure participants that their sensitive information is safe, secure, and confidential. By understanding the importance of protecting sensitive data from the view of.. READ MORE »
In the field of clinical research, pharmacovigilance represents the analysis and monitoring of drugs and medications to prevent adverse effects. In order to ensure drug safety and prevent adverse events, Health Canada has generated a list of strict practices and guidelines that must be followed by clinical research professionals and drug manufacturers. The health authority also has an inspection program in place to provide independent oversight and evaluation of manufacturer adherence to mandated reporting of adverse drug reactions, and of any efficacy failures found in new drugs. To understand more on the need to employ pharmacovigilance practices, and what some.. READ MORE »
The importance of time management in clinical trials can’t be understated, with delays and missed deadlines quickly maxing out budgets, and having the potential to terminate trials altogether. Many missed trial deadlines, according to some research, occur due to poor project management and inefficient use of time rather than poorly executed scientific approaches. With this in mind, it makes sense for students of clinical research training to get into the habit of practicing superior time management strategies now, before they begin working professionally. Here are a few basic yet effective approaches to follow. Set Your Goals When you’re taking your.. READ MORE »
Before diving into primary research, a responsible researcher will examine, evaluate, and synthesize what has already been published on the subject by writing a literature review. This article provides a succinct overview of the relevant findings on a given topic and helps researchers identify relevant frameworks for their upcoming project. Although many researchers are eager to launch new clinical trials after completing their training, it is imperative to conduct a literature review first. Understanding literature reviews will help you maximize originality, relevance, and impact in your future research career. What Is the Purpose of Literature Reviews After Clinical Research Training?.. READ MORE »
When we read health-related statistics such as 1 in 8 Canadian women are expected to develop breast cancer, or that men are typically diagnosed with heart disease around 10 years younger than women in Canada, we have biostatistics to thank for these important conclusions. Biostatistics involves analyzing and interpreting data drawn from health sciences in order to better understand public health concerns such as chronic disease, cancer, and AIDS, as well as critical concepts such as human development and the relationship between genetics and the environment. Biostatistics also plays a key role in many scientific fields, including: biology clinical medicine.. READ MORE »
If you are interested in becoming a clinical research professional, your role in the safety and marketing of pharmaceuticals or other product life cycles will be major. Whether you work in pharmacovigilance, with natural health products, cosmetics, or other related industries, understanding the phases of a product’s life cycle is key. As defined by Health Canada, the life cycle of a product includes several stages: Pre-clinical studies Clinical trials Submission of product information to regulatory agency Regulatory agency decision on whether to authorize sale of the product Public access to product Post-market surveillance, inspection, and investigation To learn more about.. READ MORE »
If you would like to combine your interest in science and health,then a career in clinical research may be the right choice. When you study clinical research, you have the chance to learn about topics such as pharmacovigilance practices.These generally refer to how pharmaceutical products are developed, tested, and monitored to ensure they are safe and consistent. One of the key components of pharmacovigilance practices for clinical research,as well as aftermarket surveillance, is safety signal interpretation. Keep reading to learn more about this process and how it factors into clinical research. What Are Safety Signals? As you take courses to.. READ MORE »
Cannabis plants contain over 100 cannabinoids and terpenoids, including the most commonly known and extracted compounds: CBD and THC. Some extractions are “whole-plant,” meaning that no single chemical or compound is concentrated in the extraction process. However, most methods of extraction are designed to target specific components of the cannabis plant. Extractions from cannabis plants are used in all sorts of products, including oils and edibles, which offer an alternative to smoking the plant and, in some cases, offer different effects. Keep reading for an introduction to this important process! Learn the Extraction Factors to Consider in a Cannabis.. READ MORE »
