The establishment of medicinal regulatory agency’s intent is in facilitating and protecting public health interest by ensuring the safety and efficacy evaluation of medicinal products (biologics, devices, drugs) and other… read more →
Innovations or inventions have many mothering factors. One of the major enticing factor is profitable societal and unmet needs. There are also altruism and noble causes driven by the optimism… read more →
Abstract Evaluating the quality of clinical data is the basis of achieving accurate conclusions in rejecting or not rejecting the null hypothesis for a research or study (Hattemer-Apostel et. al.,… read more →
The growth of technology and data standards has affected data management standards of clinical research in several ways. The most important aspect of standards is the ability to maintain data… read more →
Abstract The Oracle, ePharma Solutions, and Perceptive Informatics applies integrated and accessible EDC systems in pharmaceutical clinical trial’s data capture. However, Medidata Rave has become one of the major electronic… read more →
The best clinical practice in any clinical study is ensuring the safety of human subjects while enhancing scientific knowledge. Such scientific principle holds any clinical regulations and guidelines to the… read more →
One of the most important aspects of data collection and analysis in a clinical study is creating quality assurance sources which will ensure data integrity. As the globalization of clinical… read more →
Fundamentally, any medical practitioner or health institution will never treat a disease of condition appropriately without correctly diagnosing the disease or condition. Many clinical tests rely on the sensitivity and… read more →
Clinical study design is used to establish the statistical parameters for the scientific hypothesis being tested. In 1964, Zidovudine (AZT) was synthesized at Wayne State University for cancer therapy under… read more →
Regardless of how effective and safe a new investigational medicinal product seems; without the full compliance of participating subjects there will be no meaningful data generated in the clinical study.… read more →
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