Clinical Research

What is a Clinical Trial Management System (CTMS)

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A CTMS is a customizable software system to manage the clinical trial data generated by pharmaceutical and biotechnological companies. Starting from planning of the research proposal to the preparation, conduct, and report generation, a CTMS maintains and manages the up to date clinical trial data. The early phase clinical trial data is managed and maintained […]

Medical & Scientific Writing

Arduous Role of Medical Writers in Publication

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In the research arena, publication of trials or studies conducted is intended towards society for better understanding of the innovative ideas and concepts. But this it is not the sole motive. Other motives are to implement the conclusion in prescribing habits, healthcare resource utilization, make changes in public health policy or regulatory practices. There are […]

Clinical Research

Ophthalmology Clinical Trials

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Clinical trials are the experiments that involve the participation of human volunteers to find out whether a new treatment is safe, effective and superiority of the treatment. In Ophthalmology, clinical trials are mainly being conducted in the following therapeutic conditions: Astigmatism Cataracts Conjunctivitis, Bacterial Diabetic Macular Edema Diabetic Retinopathy Eye Disorders/Infections Glaucoma Macular Degeneration Macular […]

Clinical Research

Clinical Trials / Clinical Research in Tanzania

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In Tanzania, Health Research was started in 1897 by the incident of opening a laboratory by Dr. Koch, a German scientist. In 50 years of the country’s Independence, a lot has been done in health research, as reported by an official Newspaper. In 1912, epidemiological studies were conducted by seven Germans, following an outbreak of […]

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 […]

Medical & Scientific Writing

Plagiarism in Scientific/Medical Writing

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Plagiarism is nothing but an “act of appropriation of another person’s ideas, processes, results, or words without giving appropriate credit”. It can be categorized as: a) Plagiarism of ideas and b) Plagiarism of text (verbatim). Plagiarism sabotages one’s abilities, integrity and analytical thinking process. It restricts the plagiarist from learning the intended lessons. To avoid […]

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 […]