Endocrine disorders result from the improper functioning of endocrine glands that secrete and regulate hormones responsible for functioning of various organs. Imbalances in hormones or inability of the body to respond these hormones in a normal manner can result in…
Although the United States Food and Drug Administration (FDA) has always supported and advocated the idea of decentralized trials, the real adoption and application of decentralized aspects in trials has exponentially increased in the recent years due to travel restrictions,…
Introduction: Clinical trials are a crucial component of the pharmaceutical and medical research industry, aimed at evaluating the safety and effectiveness of new drugs, treatments, or medical devices before they can be made available to the public. These trials typically…
Clinical trials form the decisions for regulatory approval of drugs and medical devices and as a result are the most important step of a drug development program. In addition to being lengthy and costly, clinical trials involve human subjects and…
Historical events such as the sulfanilamide elixir tragedy that resulted in the mass poisoning and the deaths of hundreds of patients in the 1930s and the thalidomide scandal which caused birth defects and mortality of babies prompted the United States…
According to the World Health Organization (WHO), cancer is the leading cause of death worldwide, with a death rate of one in six in 2020 (1). Aside from the high mortality rate and morbidity associated with cancer, it also negatively…
The Orphan Drug Act (ODA) defines a rare disease as a disease or condition that affects less than 200,000 people in the United States (1). According to the European Union (EU), a rare disease is one that affects no more…
The COVID-19 pandemic has transformed the worldwide regulator performing on approval of medicine as a fast-track process and involved in mutual accord in bringing a drug of importance for the civic. This is a major challenge as the safety and…
“Select a Strategic Partner who can guide you through the entire Drug Development process in an Integrated Format” Introduction CRO’s are the businesses that provide support to the pharmaceutical, biotechnology, and medical device industries within the style of research services…
According to WHO, there are 42 vaccine candidates that have reached various phases of the clinical stage of development. “The vaccine is coming soon” is what the general mindset is. The question, however, we are facing currently in these worldwide…