Elevate your herbal brand by embracing clinical trials—uncover how scientifically backed validation can transform herbal products into trusted, market-leading solutions Abstract The herbal product industry is undergoing a transformative shift as companies increasingly integrate clinical trials to validate the safety…
Patients are the heart of all clinical trials ranging from recruitment, retention, protocol adherence, assessments, and safety data, making it necessary to ensure that patients arewell-informed on trial protocol, conduct, and patients’ rights. Various measures are in place such as…
Clinical trials are undergoing a paradigm shift from a site-centric or traditional approach wherein the patients are required to go to central sites for consent processes, assessments, and safety monitoring to a ‘decentralized’ or ‘hybrid’ approach in which some or…
In the United States, The Food and Drug Administration (FDA) regulates and oversees clinical trials of food and dietary supplements and develops various regulations and guidelines for their use. The FDA defines ‘food’ as per the Food, Drug, and Cosmetic…
The technologies we use on a daily basis – from search engines to streaming music services – recognize patterns in our behaviors and, coupled with vast amounts of data from millions of other individuals, make predictions of what each of…
Working with a variety of stakeholders to positively change clinical trials, making them more streamlined, efficient, and patient-focused requires transformational shifts in the design and conduct of clinical research (clinical trials). Let’s take a look at the evolution of clinical…
The world is now several months into the “Coronavirus disease (COVID-19)” global pandemic caused by the SARS-CoV-2 virus. As lockdown restrictions slowly begin to lift in certain regions, the pursuit for a safe and effective vaccine against the virus continues…
In the Drug Development process, clinical research plays a key role because the approval from the FDA requires clinical trials to signify the safety and efficacy of pharmaceutical products. Clinical research helps in grasping and applying knowledge for products or…
FDA officials shared their insights on how drug makers can be more efficient when developing treatments for rare diseases, according to comments at the National Organization for Rare Disorders (NORD) Summit in Washington, DC. Despite the growing number of new…
Researchers agree that the highest standards in clinical research need to be preserved to maintain the public’s confidence in their work, competence, and ethics. With patient safety as a primary consideration, the implementation of safety monitoring is paramount. One means…