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Posts Tagged: clinical research program

GVP and GCP Inspections: How They Affect Clinical Research

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 »

Importance of Data Privacy and Security in Trials: An Overview for Students of Clinical Research Training

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 »

Good Pharmacovigilance Practices for Students in Clinical Research Programs to Follow

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 »

An Intro to Post-marketing Surveillance for Clinical Research Program Students

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 »

Descriptive vs. Inferential Statistics and What They Mean for Students in Clinical Research Training

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 »

In Clinical Research Training? Here’s How a Heart Medication Could Help Treat Cancer

As cancer treatment research works towards drugs that have anti-aging properties, this may help treat or prevent the spread of growths. Since poorly aging cells can enable the development of the disease, this could act as an effective treatment. The process of aging in cells is called senescence. Senescence is normal and is the body’s way of getting rid of older, damaged matter. However, when the process is not taking place normally, it is thought that this can allow tumors to grow. Drugs that eliminate poorly aging cells are called senolytics. Read on for how scientists have discovered a pre-existing.. READ MORE »

What Students in Clinical Research Programs Should know about Protein Chemistry

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 »

A Look at Gender Representation in Clinical Trials for Students in Clinical Research Courses

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 »

How Your Clinical Research Diploma Can Help Dispel Myths Around Mice-Based Studies

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!

Diversity in Clinical Trials: What Students in Clinical Research Courses Should Know

A major benefit of clinical trials is the ability to test on multiple participants, ensuring that an outcome isn’t just tied to one person. However, the diversity of these multiple participants is important, to ensure that the results coincide with how the drug will be used once approved. Sex and race can play a part in how medications work and whether a person is likely to participate in a clinical trial. Read on to learn a little bit more about what you should know about making studies inclusive, accurate, and effective. Why Diversity Matters for Effective Clinical Research Diversity of.. READ MORE »

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