Clinical Research

Introduction to MedDRA:

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MedDRA, the Medical Dictionary for Regulatory Activities, is a medical terminology used to classify adverse event information associated with the use of biopharmaceuticals and other medical products. (Defined by MedDRA MSSO). Big-Pharma used one or more available sources for medical terminology coding, like COSTART, WHO-ART, WHO-DRUG, etc., for many years. But in order to bring […]

Clinical Research

Biostatistics in Clinical Trials:

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Biostatistics an application of statistics is nothing but the science of the analyzing design and data of biological experiments, especially in medicine and related research. By definition, it is the collection, summarization, and analysis of data from those experiments; and the interpretation of, and inference from, the results. Statistical analyses may be helpful in answering […]

Clinical Research

Stem Cell Technology

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Stem cell research is being hailed to answer many unanswered questions in modern medicine. The regenerative ability of stem cells brought a revolution in the world of medicine, in re-formation of many organs like heart, kidney, lungs, etc. But there is a dispute going on this regeneration process as the stem cells used for this […]

Clinical Research

Role of Institutional Ethics Committee (IEC) in Clinical Trials

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Submitted by: Ms. Kalpana Peyyeti, BAMS, PGDCR – JLI Global Clinical Research Academy, Lakdi-ka-pul, Hyderabad As per the WHO definition, a clinical trial is any research study that prospectively assigns human participants to one or more health related interventions to evaluate the effects on health outcome. Ethics are concerned with the distinction between Right and […]

Clinical Research

Misconceptions in HIV Vaccine Clinical Trials

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Vaccine clinical trials are long-term studies aimed at assessing the safety, efficacy and immunogenicity of a new vaccine product. Sometimes trials also assess how well the product meshes with existing healthcare delivery systems, such as national immunization programs. The clinical trials that are conducted to prevent the transmission of Human Immunodeficiency Virus come under Vaccine […]

Clinical Research

Role of Physicians in Clinical Research

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To define, ‘Clinical research involves the study of human beings in a systematic investigation of human biology, health, or illness, designed to develop or contribute to generalizable knowledge’. Clinical research includes a set of activities that are meant to test a hypothesis, formed on particular treatments/diagnostics/medical devices and so on. The conclusions drawn from such […]

Clinical Research

Business Development at Clinical Trial Sites

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Business development from a clinical trial site perspective is increasing the probability of securing research studies needed by it to keep it in business. The process of acquiring a research study and securing the study is known as “Business Development”. In clinical research industry, all clinical trial personnel can contribute to this process. An active […]

Clinical Research

What is Nanotechnology? An Introduction:

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Nanotechnology is defined as the engineering of functional systems at the molecular scale. In lay terms, nanotechnology is the molecular level processing and development of devices to carryout biological functions in a simpler way. In medicine, nanotechnology is being used in the drug development process and research that involves the use of manufactured nano-robots to […]