Do you have scientific evidence that the country chosen is a perfect destination to conduct your clinical trial? Does the country you have chosen provide all the resources to conduct clinical trials? Have you compared it with other eligible regions? To find answers to all these questions, you need to perform proper clinical trial feasibility. […]
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The global contract research organization market value reached $39 billion in 2018 and is expected to exceed $51 billion by 2024. The market is becoming competitive, with large CROs going for acquisitions and mergers to increase the portfolio and reach, whereas small and medium CROs are becoming more prominent with their personalized approach, contact flexibility, […]
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The Japanese medical device market stands second after the USA. The global data expects the Japanese medical device market to grow from $54.5 billion in 2018 to $74.7 billion in 2025, at a compound annual growth rate of 4.6% (CAGR). Note: This article was updated in September, 2022. Top reasons to choose Japan for your medical device market […]
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This article is a sequence of the Regulatory & Drug Approval Process in the United States, Part-I, which describes the Investigational New Drug (IND) approval process, New Drug Approval (NDA), and Generic drug approval process. In this article, we will discuss the market approval process of biologics, biosimilars, orphan drugs, and various drug approval pathways. Which is the regulatory authority […]
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The United States represents the largest continental pharma market worldwide and holds around 45% global market. The pharmaceutical market in the United States was expected to increase from $354bn in 2015 to $497bn by 2020. The FDA is the main regulatory body that handles drug approval in the United States. Though markets like China and […]
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The drug approval process in Japan is less complex and easy when compared to some other countries beyond the language barriers. In addition to regulatory considerations, the PMDA offers sponsors consultation to assist them in understanding the prerequisites and the detailed procedure for drug approval. As a result of this positive change, many manufacturers choose […]
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Clinical research professionals and staff members say that one of their biggest challenges in conducting a clinical trial is patient recruitment which is obtaining a sufficient number of participants for a clinical trial. If the clinical research team fails to enroll enough study subjects into a clinical trial, this may, by default, extend the study […]
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Many companies spend a significant amount of cost and manpower on software and data management tools/systems to handle clinical trial activities to build, monitor, and manage clinical trial data. Researchers and CRO utilize many software, web-based applications, and cloud source management tools in various stages of clinical development, and here are some of them Now, […]
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 […]
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In recent years, there is a huge leap in the pharma industry towards rare disease research and orphan drug developments due to the great support from regulatory authorities such as faster approval timelines, supportive regulatory frameworks, financial incentives, and many more. Currently, large pharmaceutical companies like Novartis, GSK, Roche, and Pfizer are extremely active in […]
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