Rare diseases are rapidly becoming a high priority therapeutic area for our industry. This is needed, especially when fewer than 5% of approx 7,000 rare diseases have drug therapies available, and many of these provide limited benefit. There is also a business case to this, due to a supportive reimbursement environment, particularly in the US. […]

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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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Thailand FDA periodically releases list of of institutional review boards (IRBs) / ethics committees (ECs) that it recognizes for acceptance of clinical trials. Under Thailand regulatory system, approved ethics committees serve as the main point of approvals for initiating clinical trials in the country. This has been explained in our previous articles (see Part I and Part II), […]

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Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease or motor neuron disease (MND), is a fatal disease of the nervous system, characterized by progressive muscle weakness resulting in paralysis. Symptoms include stiff muscles, muscle twitching, and gradually worsening weakness due to muscles decreasing in size. In ALS, moton neurons controlling the voluntary muscles, […]

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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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Gastro-Intestinal (GI) drugs market is a potentially huge market with many different indications, drug types and treatment regimens. Transparency Market Research and PRNewswire reports predict the global GI drugs market to grow with a CAGR between 4.5 % and 5.0 % from 2017 to 2023. While, it was worth USD 46.5 Billion in 2016, it […]

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South Korea is a well-reputed country with lots of years of clinical research to their credit. In fact, it has a longer history of conducting global clinical trials than most of other Asian countries including Japan. More than 80% of clinical trials conducted in South Korea are global, which is a great indicator of suitability […]

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Health Canada (HC) reviews, evaluates, and approves applications for clinical trials using authorized therapeutic products in Canada. HC assesses clinical trial protocols to evaluate participant protection and safety; reviews drug quality; assures institutional ethics committee review; verifies principal investigator qualifications; and monitors and reviews adverse drug reactions. HC also approves the sale or importation of […]

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Best reasons to conduct clinical trials in any country include availability of patients, clarity of regulatory processes, willing and qualified investigators and a sound infrastructure with a reasonable cost. This is what you get if you conduct clinical trials in Romania. Let’s see this in greater details. Brief Demography Romania is a sovereign state located in Southeastern Europe […]

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