As more treatments arrive on the market, clinical research ensures they have been proven safe and effective for public use. Today, it’s not just the treatment that comes under scrutiny but the research process itself. Any clinical research that involves human subjects must comply with ethical standards. A big part of ethical research is getting the informed consent of participants. But many people think that informed consent is what makes clinical research ethical. In reality, informed consent is not the only mark of ethical research. Similarly, there’s a belief that informed consent simply means getting a signature. In fact, a.. READ MORE »
A clear and well-documented clinical development plan (CDP) is the foundation of any good clinical study. In fact, it is a requirement for any pharmaceutical company that intends to develop and test a new drug. The CDP is a description of clinical trials that will be carried out on a drug to assess its safety and effectiveness. It covers everything from the reason for development to the features of the trial, timelines, costs, and other resources. Therefore, a good CDP must take into account regulations surrounding clinical trials, as well as good clinical practices. If you’re getting started in the.. READ MORE »
Any drugs distributed on the Canadian market must remain safe and effective for public use. Pharmacovigilance inspections ensure that the establishments producing those drugs are following the correct regulatory requirements. This involves performing GCP and GVP inspections. GCP inspections happen during the clinical trial stage to ensure compliance, while GVP inspections happen in the post-approval stage to verify that establishments continue to evaluate the safety and effectiveness of their drugs. As a professional working in clinical research, you should have a clear understanding of the goals, process and impact of these inspections. With this knowledge, you’ll be ready to handle.. READ MORE »
The medical industry, like many other industries, is constantly evolving. Advancements in technology and changes in society create new trends that impact the field of healthcare. These changes can come in various forms, introducing new healthcare approaches as well as new medical devices. This gives students an exciting opportunity to discover new developments in their field. Medical devices are an essential part of the healthcare industry, allowing certified practitioners to deliver necessary care and optimize their services. As these devices continue to evolve, practitioners are able to better diagnose and treat illnesses. Clinical research students are able to learn more.. READ MORE »
Clinical data management (CDM) is a critical process within the realm of clinical research and trial. CDM can be defined as the process of collecting, cleansing, and managing data throughout a clinical trial, producing accurate, reliable data which can be used for the safe development of drugs and treatments. Not only does a sound CDM process reduce the amount of time it takes for a drug to become marketable, but it also ensures that pharmaceutical companies are compliant with regulatory requirements, enhancing safety around consumption. If you’re pursuing a career in clinical research, your knowledge of the CDM process will.. READ MORE »
Within the highly regulated and ever-important field of Clinical Research, there are a variety of roles and responsibilities to be fulfilled. Skilled professionals are needed in order to ensure compliance with legislation and regulatory agencies, enforce standard operating procedures, create clinical development plans, maintain accurate data and monitor confidentiality and protection of participants’ rights. The work of professionals in the clinical research field contributes to the safe and effective development, distribution and consumption of drugs or treatments. As a result, those with training in Clinical Research and Pharmacovigilance are in high demand. When you complete a training program with AAPS,.. READ MORE »
If you’re pursuing a career in clinical research, you’re probably already aware of the essential nature of clinical research trials in the safe development of new treatments. However, the established clinical research trial process has long been hindered by drawn out timelines, outdated methods and strain related to extensive resources. Recently, both decentralized and digital clinical trials have gained prominence as new methods of doing what clinical trials have always done: gathering data from participants using a treatment or drug within a controlled setting and time frame. Both have the power to change the way that clinical trials are conducted,.. READ MORE »
Clinical Safety and Pharmacovigilance Certificate courses are formatted to help students gain specialized knowledge of the most recent developments in clinical research, drug development, and pharmacovigilance. One of the biggest developments and an ongoing topic of interest in clinical research is medical devices. As technology advances, new medical devices are introduced and must undergo the approval process for use in the healthcare industry. Our courses outline both Canadian healthcare as well as the global healthcare system, giving students an understanding of the relationship between international guidelines and standard operating procedures in regards to medical devices. With extensive hands-on training at.. READ MORE »
Clinical audits benefit both researchers and patients in the pharmaceutical industry. An audit assesses the quality of an area of health care to determine whether it meets a certain standard. Care providers can learn where their service is doing well, and in what ways they can improve. The ultimate goal is to provide the best possible outcomes for patients. Conducting a clinical audit is a careful process that requires planning, vigilance, and direction. Being aware of potential obstacles can also ensure the audit runs smoothly and efficiently. Most importantly, auditors need to set clear standards to measure performance. With reliable.. READ MORE »
Every clinical research study begins with the preparation of a clinical trial protocol. The protocol is a document that details the study objectives, design, methodology, collection schedules, and statistical analysis of data. Clinical study protocols form the foundation of clinical trials, ensuring the safety of the subjects and the quality of the data collected. Beyond that, protocols provide the reason for conducting the study and the main research questions it will address. With so many areas to cover, protocols must be formulated carefully to ensure that the trial is operationally feasible and compliant with regulations. Protocols that lack certain details.. READ MORE »
