Do you ever wonder how prescription medications make their way to your local pharmacy? Clinical trials and health research play a vital role in maintaining the world population’s health on a regular basis. Without the proper research and clinical trials, many patients would still be suffering from ailments that are easily cured with medications now. […]
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Effective 2nd August 2016, the Central Drugs Standard Control Organization (CDSCO) India released new circulars in relation to the conduct of clinical trials. These new circulars have modified the trial requirements for sponsors wishing to conduct clinical trials in India. Furthermore, the CDSCO have addressed matters that may assist in reducing clinical trial timelines and […]
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EDC has become the data management platform of choice around the world, offering advantages such as increasing the quality and timely collection of data. Medrio, an EDC company that offers eClinical software solutions, has quoted that 70% of clinical trials are using EDC as a forms of collecting data in the United States. In China, […]
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The rising presence of clinical trials (CT) in the Asia-Pacific region is predominantly driven by the East Asian region which includes China, Japan, Korea, Taiwan and Hong Kong. Over the past decade, Korea has become a global clinical trial hub and is one of the leading clinical trial destinations in the Asian region; with approximately […]
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In Australia, The Therapeutic Goods Administration (TGA) is responsible for the regulation of therapeutic goods (TG) – including medicines, vaccines, medical devices, in-vitro diagnostics and biologicals. They provide oversight over manufacturing, import and export of therapeutic goods, clinical trials (CT) and regulatory approvals processes. Australia is well known for its efficient CT start up timelines; […]
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If you haven’t thought about diabetes before, it is time to stop and think for a minute. Why, you might ask? The World Health Organization’s figures from last year estimate over 350 million people worldwide have diabetes. The emerging epidemic is attributed to the rapid increases in overweight, obese and physically inactive individuals. Diabetes is […]
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Extensive investigator networks, cultivated over the course of some of the world’s largest clinical trials into the risk factors for dementia, presents an exciting opportunity for the future of dementia trials. Diabetes, hypertension, stroke, vascular disease, smoking, poor diet, physical inactivity and even depression have been linked to an increase in the likelihood of an […]
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The concept of grouping subjects for randomization is called cluster randomized trials (CRT) – this concept is becoming increasingly common when randomizing large groups. However, when CRTs involve interventions at a cluster level, informed consent from participants may not always be possible to obtain. As informed consent is a fundamental ethical requirement for clinical trials, […]
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A Phase I study is the first time a new drug or treatment procedure is tested in-humans. The purpose of this phase is to determine the metabolism and pharmacologic actions of the drug in-humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. Phase I studies in-human participants […]
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An ongoing study in Australia is showing how computer games can help patients recovering from strokes, brain injuries, amputations and other conditions. The study is the largest trial of its kind to utilize computer gaming technology in rehabilitation. The George Institute’s Professor Cathie Sherrington is leading this study that is testing a wide range of […]
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