Every year, hundreds of clinical trials are conducted in Canada to test new drugs for approved use on humans. Clinical trials serve as an evidentiary basis for determining whether medicines are safe and effective. Monitoring patient safety during clinical trials is a critical practice throughout the whole drug development process. With the high costs of conducting clinical trials, the pharmaceutical industry can benefit from clear safety evaluations that can lead to better patient protection and save development costs. Clinical safety is a collaborative concern that involves sponsors, sites, researchers, and any personnel in the clinical trial phases. As the industry.. 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 »
It may come as no surprise that COVID-19 significantly accelerated digitalization in clinical research and the pharmaceutical industry. However, new technology introduces new concerns that impact the development of future clinical research. That is also the case with Blockchain technology, introducing many benefits and notable considerations to the field. Students taking a clinical research program know that trust is a key factor in clinical research, and it is drastically changing in the public eye. In today’s society, trust is no longer given by default but is earned through proof instead. As such, “trusted data” becomes a requirement. Blockchain technology could.. 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 »
The COVID-19 pandemic has turned the spotlight on the global healthcare industry, putting its strategies and responses under the lens. Industry leaders are forced to examine the efficiency of clinical research procedures in forecasting new outbreaks and managing their spread. Big data analytics has been at the heart of the industry’s response to the global pandemic. Over the past year, new technologies have been used to understand, track, and contain the virus, with a profound impact on the way clinical research is conducted. As the nature of healthcare changes, the demand for clinical research professionals has never been greater. For.. READ MORE »
Conducting clinical trials requires specialized knowledge in order to write study protocols, conduct drug safety activities, and monitor the trials. Clinical research professionals are required to demonstrate that clinical work has been performed in compliance with regulations and operational practices. Standard operating procedures (SOPs) are designed for that purpose. SOPs are a set of instructions that define and standardize procedures in clinical trials. They clearly document the rules of procedure to maintain consistency and accuracy. Students in clinical research training explore the global and national healthcare systems, including health care legislation, guidelines, and standard operating procedures (SOPs). With an understanding.. 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 »
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 »
