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 […]
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For the approximately 7,000 known rare diseases, less than 10% of diseases have an FDA-approved treatment available. Due to a small number of patients, limited understanding of the variability and progression of the diseases, developing a drug or treatment for rare diseases is often challenging. As the disease is rare, finding sites to conduct clinical […]
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The US FDA recommends efficient clinical trial design strategies such as basket designs, and umbrella designs to expedite the development of oncology drugs and biologics. FDA also provides guidance and advice to sponsors of drugs and biologics for cancer treatment regarding the design and conduct of clinical trials, other than first-in-human (FIH) trials. In contrast […]
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To make a clinical trial faster, cost-efficient, and more successful, it all starts with a strategic design of a clinical trial, and the sturdy trial design is essential to ensure a successful clinical outcome. A proper study design determines the fate of the clinical trial and its likeliness to be successful. A study design involves […]
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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 […]
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Drug development is the process of bringing a new pharmaceutical drug to the market after identifying a lead compound through drug discovery. The drug development process starts from drug discovery and ends gaining market approval and post-marketing studies, This entire process of medical device/drug development takes years and depends on many factors such as Type […]
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The European medical device market represents about 30% of the global market, after the U.S. market with a 42% share. The rising geriatric population, an increasing number of surgical procedures (especially orthopedic), and the availability of funding for research and innovation are some of the driving factors for the growth of the medical device market […]
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One of the most sought-after markets for medical devices globally is the Australian market. With the regulatory reforms and increasing demand for innovative products, the Australian medical device market expectation was worth more than $4.56 billion by 2025, growing at a CAGR of 10%. In this article, we will be discussing the medical device approval […]
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Small and Mid-Sized Contract Research Organizations (CROs) for clinical trials occupy approximately about 44% of the market share of outsourced development works. These CROs are gaining interest and becoming the choice for startups, small and mid-sized pharmaceutical and biological companies. While in the first part of this article series on “Contract Research Organizations For Your […]
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The United States remains the largest medical device market in the world with $156 billion which is 40 percent of the global medical device market in 2017 and By 2023, it is expected to grow to $208 billion The medical technology industry (commonly referred to as medical devices) consists of articles, instruments, apparatuses, or machines […]
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