Do you know according to clinicaltrials.gov a total of 354,130 clinical trials were registered worldwide with 71,256 ongoing trials as recorded on Oct-2020? The number of trials being conducted is increasing year by year from 56.16k in 2017 to 60.69k in 2018. In the US more than 2.3+ million people participate in approximately 80,000+ clinical […]

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Clinical trials in rare diseases are more challenging than clinical trials in more frequent diseases for many factors such as the trial design, the number of patient populations available for recruitment, require regulatory support, etc. Applying a perfect clinical development strategy may help in overcoming these challenges and accelerate the drug development process in Orphan […]

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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. Rare diseases currently affect 3.5% – 5.9% of the worldwide […]

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The US FDA recommends efficient clinical trial design strategies 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 to traditional trial designs, where a single […]

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To make a clinical trial faster, less costly, and more successful it all starts with strategically designing a clinical trial. The sturdy trial design is essential to ensure a successful clinical outcome. A proper study design determines the fate of the clinical trials and their likeliness to be successful as it involves many deciding parameters […]

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Drug development is a lengthy, complex, and costly process, entrenched with a high degree of uncertainty that a drug will actually succeed and reach the market successfully. Drug development is the process of bringing a new pharmaceutical drug or a medical device or a treatment procedure to the market. Many developers often lack a clear […]

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Drug development is a process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. The drug development process starts from drug discovery to getting market approval and post-marketing studies. This entire process of medical device/drug development takes years and completely depends on […]

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The Europe medical device market represents about 30% of the global market, after the U.S market with a 42% share. 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 in […]

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One of the most sought after markets for medical devices in the world is the Australian market. With the regulatory reforms and an increase in demand for innovative products, the Australian medical device market is expected to be worth more than $4.56 billion by 2025 growing at a CAGR of 10%. There is a growing […]

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Small and mid-size CROs occupy about 44% of the market share of outsourced development works, approximately. 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 Clinical Trials“, the top 10 CROs […]

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