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 »
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 »
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 »
Over the past decade Canada has made significant investments into clinical trial health research through educational institutions, research centres, and hospitals. These investments are intended to maintain Canada’s status as a top site for global pharmaceutical companies to do clinical trial research. It is therefore important for anyone interested in clinical research to understand the roles of different branches of statistics in this area of study. From research and development to post-marketing monitoring of pharmaceuticals, clinical research relies on statistics. To test hypotheses, answer questions, and adhere to regulations, a study or trial must be designed to gather the appropriate.. READ MORE »
The product development lifecycle of drugs is longer than many people think. New therapeutic products, which are drugs or biologics, undergo a complex process that takes approximately 10 to 12 years from start to finish. When you work in clinical research, you will play a role in the industry that brings new drugs and medical devices to market. There are many stages to this process, all of which are important. Without clinical research, this process wouldn’t be complete. Read on to learn more about what’s involved in a drug lifecycle, with a focus on why clinical research is an integral.. READ MORE »
When you study pharmaceutical biotechnology in your clinical research studies, you will learn about protein chemistry as a part of developing your understanding of fundamental concepts of biotechnology. The chemistry of proteins, combined with microbiology, immunology, and molecular genetics, provides foundational knowledge that is applicable to strategies used in research and drug safety. If you choose to work in clinical research, drug safety, or pharmacovigilance, these fundamentals will support the work you do. Understanding proteins is important to a career in pharmaceuticals. Proteins are essential to chemical processes that support life and are integral to many functions of the human.. READ MORE »
When conducting clinical trials, results can depend on how diverse the population of participants is. Clinical trial diversity is essential for: Accuracy Effectiveness Reduction of bias Gender bias in particular is an issue currently being addressed within clinical trials. Because there has historically been a bias towards male study participants in medical research, there is a lack of data by comparison on females and how they react to drugs. Read on to learn why gender diversity in clinical trials is so important, and what can be done to improve it! Why Inclusion Is Important to Graduates of Clinical Research Programs.. READ MORE »
Media skew and public misinformation can confuse people about mice-based studies. You can use your clinical research diploma to combat these myths. Read on!
Asthma affects three million people in Canada, which is why treatments receive a lot of focus from professionals with a clinical research diploma. Learn more.