The clinical research landscape is shifting drastically due to an increase in the availability of electronic data allowing researchers to make assessments based on available real-world evidence (RWE) obtained from the analysis of real-world data (RWD). Global regulators are encouraging researchers/drug developers utilize the RWE for submissions. Many regulators are accepting the Real-world evidence (RWE) […]
Read More →Oncology trials are more complex than trials in any other therapeutic area. Research in oncology differs in terms of trial design, trial types, the role of a comparator, treatment outcomes, adverse event reporting, interpreting the results, and more. Developing a well-defined clinical development strategy for oncology clinical trials is crucial due to the significant costs, […]
Read More →Do you know, according to clinicaltrials.gov, a total of 354,130 clinical trials were registered worldwide with 71,256 ongoing clinical trials as recorded on Oct-2020? The number of clinical trials is increasing year by year from 56.16k in 2017 to 60.69k in 2018. In the USA, more than 2.3+ million people participate in approximately 80,000+ clinical […]
Read More →Clinical trials in rare diseases present more significant challenges compared to trials in more common diseases. These challenges arise due to various factors, including trial design, the limited patient population for recruitment, regulatory support, and more. However, implementing a well-defined strategy for clinical development in rare diseases can help overcome these challenges. Such a strategy […]
Read More →Drug development is a lengthy, complex, and costly process entrenched with a high uncertainty that a drug will successfully reach the market. So for this, you need a proper drug development strategy to avoid uncertainties and complete clinical trials in time with quality data. Drug development is the process to bring a new pharmaceutical drug […]
Read More →Many people with rare diseases struggle to find the right diagnosis and right treatment for years. The lack of awareness about these conditions makes it much harder for them to get the right treatment. Rare Disease Day is all about raising awareness for rare diseases. And, this year, you can join these efforts too. The […]
Read More →Many regulatory agencies across the world are offering incentives for the development of orphan drugs for rare diseases. These incentives include financial benefits, faster approvals, less stringent clinical data requirements, and many more. The countries that are offering the regulatory incentives for orphan drugs include the US, Europe, Japan, Australia, South Korea, Brazil, and most […]
Read More →Most of the processes to approve drugs in the EU are similar to those of the FDA, such as getting pre-authorization for use of the drug in clinical trials. After clinical trials, FDA drug approvals follow a centralized path, whereas European approval can occur through 4 different paths, depending on the nature of the drug, timeline, […]
Read More →Nutraceuticals or Health supplements are gaining importance and becoming a part of the consumer’s daily diet. With the increase in life expectancy and subsequent increase in lifestyle-related diseases, nutraceutical or health supplements have emerged as a necessity for consumers, especially in a developed market and Europe is not an exception to it! Novel food represents […]
Read More →Nutraceuticals, dietary supplements, or food supplements, also known as “Health Supplements,” have been used for years to maintain, enhance, and improve the healthy function of the human body. They may contain a combination of vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other bioactive substances. Each country differs in its regulatory requirements for registration […]
Read More →