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. […]
Read More
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 […]
Read More
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, […]
Read More
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 […]
Read More
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; […]
Read More
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, […]
Read More
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 […]
Read More
Access to large markets where clinical trials that can investigate real patient needs, and do so in a rapid fashion, is invaluable for clinical research organisations. One such example of George Clinical rapid and access to huge markets took place in China, where diabetes patients numbered up to 90 million in 2010, and the most […]
Read More
Either because of financial, legal or operational reasons, many companies including those in healthcare, are still stuck in the paper world when it comes to data and document management. Now that technology has become so much more advanced, switching to electronic health data format has a slew of advantages and benefits that can’t and shouldn’t […]
Read More
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 […]
Read More
