Cost and time for clinical development constitute more than 70% of 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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Colorectal cancer (CRC), also known as bowel cancer and colon cancer, is the development of cancer from the colon or rectum. Globally, colorectal cancer is the third most common type of cancer in both men and women making up about 10% of all cases. Currently, there is a significant focus on development of drugs for […]

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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.1 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 that with 469 new clinical trials 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 Status of clinical research has degraded over […]

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Identification and selection of clinical sites and investigator remains one of the first and most important decisions that 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 and […]

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The United States has consistently emerged as a leading site for clinical research. Clinicaltrials.gov registry, which serves as an effective reference to see clinical trials conducted worldwide, provides an interesting statistics regarding U.S. clinical trials. Clinical trials statistics in the U.S. A glimpse into the studies registered between 2011 and 2013 and further between 2014 […]

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From that first randomized clinical trial on board HMS Salisbury in 1747, we’ve come a long way! Still, there is more to be done. More horizons are to be explored, more medicines to be developed, and more patients to be cured. Let’s celebrate May 20, 2017 as a new beginning to even better, even faster […]

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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 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 paper […]

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Taiwan is emerging as a big player in the Asian clinical trial market. There are many advantages of conducting clinical trials in Taiwan, which have been discussed in Part 1 of this blog. In this part, let’s talk a bit on the clinical trial regulatory scenario in Taiwan, including the approvals required and how to be prepared […]

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

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