Cost and time for clinical development constitute more than 70% of the total development of any drug! Small – mid-scale biopharma are known for their innovative approaches, agility, and faster developments. However, clinical development has always been one step too important, yet too hard for them. There are ways to overcome these challenges and optimize […]

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Acute vestibulopathy is characterized by an acute or subacute onset of vertigo, dizziness, or imbalance with or without ocular motor, sensory, postural or autonomic symptoms, and signs, and can last for seconds to up to several days. What is Acute Unilateral Vestibulopathy? Normal vestibular end organs generate an equal resting-firing frequency of the axons, which […]

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Poland is regarded as one of the largest clinical trials markets in CEE/CIS. In a report in 2010, PriceWaterhouseCoopers (PwC) pointed out that with 469 new clinical trial registrations in 2009, Poland accounted for c. 2.5%-3.0% of the world market by registration volumes. Current status of clinical research in Poland The status of clinical research has […]

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Identification and selection of clinical trial sites and clinical investigators remain one of the first and most crucial decisions that clinical trial managers take. This also happens to be the one that may define the success (or, failure) of the project. We had been seeing the impact of site/investigator identification on clinical trial successes time […]

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The United States has consistently emerged as a leading site for clinical research. Half of the total clinical trials conducted worldwide are being conducted in the United States. Most of the research pharma companies prefer to perform their clinical trials in the United States due to the reasons such as well-established medical infrastructure, fast approval […]

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Trial managers worldwide have been focusing on specific regions for placing their clinical trials. So much so that about 60-70% of clinical trials globally are conducted in the USA and Europe alone. However, this is slated to change or should change, if one consults a recent white paper published by Frost & Sullivan. The white […]

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Taiwan is emerging as a big player in the Asian clinical trial market. Taiwan has many advantages for conducting clinical trials. Refer to Part 1 of this blog for more details. In this part, let’s talk a bit about the clinical trial regulatory scenario in Taiwan, including the approvals required and how to be prepared for it. Top […]

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Recently, the Thailand FDA has brought a revised list of Institutional Review Boards (IRBs)/Ethics Committees (ECs) that it recognizes for acceptance of clinical trial applications. In our previous articles (see Part I and Part II), we’ve discussed the regulatory scenario in Thailand, including regulatory approvals for the clinical trial in Thailand, ethics committee approval for the clinical trial […]

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Taiwan has one of the most progressive healthcare systems in the world and is a major hub for clinical research in the Asia-Pacific region. Currently, it is well-positioned to meet the growing demands of the global clinical trial market. World-class, high-quality infrastructure, low cost, easy patient recruitment process due to dense populations are a few of the […]

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Investigators, from Brazil who were specialized in Allergy and Immunology segment, were invited to participate in feasibility of a new phase II clinical trial. What’s was the trial about? It’s a phase II – dose selection and confirmatory – clinical trial planned to be conducted in Brazil. What kind of patients were required for this clinical trial? […]

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