Pharmacovigilance ensures and safeguards the safety of medications, from their development in clinical trials to post-market surveillance. As the field evolves, staying up to date with emerging trends is vital for anyone pursuing a career in clinical research. Understanding these trends can provide a significant advantage for students enrolled in AAPS’s clinical research program as they prepare to enter the workforce. Below, we explore the top five trends in pharmacovigilance shaping the industry’s future and what they mean for clinical research students. 1. Increased Use of Artificial Intelligence (AI) and Machine Learning (ML) and Big Data Integrating AI, ML, and.. 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 »
In recent years, decentralized clinical trials have generated much discussion for the pharmaceutical industry. Decentralized trials offer a new model of clinical research that incorporates new technologies and remote assessments, with the aim to gather more diverse and inclusive data and offer improved patient care. With the move to a patient-centric approach, decentralized trials are finding ways to accommodate various patient needs that are often neglected in traditional trials. In the ongoing COVID-19 pandemic, the pharmaceutical industry has been forced to meet operational challenges with innovative solutions that make use of technological advances. With the disruption of in-person activities, research.. READ MORE »
In recent years, digital technologies have transformed numerous aspects of the healthcare system. When it comes to clinical trials, digital health technologies offer feasible solutions to improve the accuracy, efficiency, and cost-effectiveness of research. Clinical research trials are often burdened by slow enrollment, high costs, repetitive procedures, and other patient variables. To maximize the value of trials, the healthcare industry needs to reconfigure the way clinical research is conducted. Solutions that offer an improved participant experience and more efficient measuring techniques are the best bet. Digital technologies offer a way to accelerate clinical trials outside of research sites. The result.. READ MORE »
What if science wasn’t public knowledge? Without scientific communication, it very well might not be. Scientific communication is the system of disseminating scientific discoveries, updates and arguments to the public. Scientific communication serves to raise awareness of topics related to science through different methods of education within various communication channels. While the practice of scientific communication has existed since the 19th century, today the field is changing as technology, social media, and new societal understandings are transforming how scientific information is related to the public. If you’re considering a career in the field of clinical research, understanding how scientific communication.. READ MORE »
As long as people continue to desire personalized treatment options when they get sick, there will be a need for clinical research professionals. Put simply, clinical research involves conducting trials to ensure the safety and effectiveness of drugs before public distribution, as well as ensuring regulatory compliance is maintained at all times. These trials and studies are what researchers rely on to make sure drug treatments can officially be brought to market. Having a career in this field allows you to work directly in developing treatments that help others with their health issues. Anyone hoping for a career in healthcare.. READ MORE »
Statistical analysis is a critical component in an evidence-based clinical research process. Statistical analysis is the process of collecting and analyzing data gathered to determine trends and patterns. Using statistical analysis allows researchers to establish whether the data they’ve obtained supports their research question. When approaching a clinical research study, it’s important to start the process with a statistical analysis plan (SAP), choosing the statistical methods which are appropriate for the study at hand. Despite its importance, developing a statistical analysis plan for clinical research can be a complicated task, especially if your research framework isn’t totally air tight. If.. READ MORE »
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 »
