Eligibility

• MBBS/ BDS/ BAMS/ etc.-Candidates with graduate/ post-graduate qualifications in Medical and allied fields like dentistry, homoeopathy, Ayurveda and veterinary science, and pharmacy
• Pharma Candidates B. Pharm/ M. Pharm/ Pharm. D
• M.Sc. / B.Sc. (Life Sciences) – Graduate and Post-graduate in Biological sciences (microbiology, biotechnology, botany, zoology), basic science (chemistry), nursing, physiotherapy, occupational therapy, social sciences with work experience in clinical research.

 Course Outline

We offer a wide range of Training Programs in Clinical Trial Management, Clinical Operation, Medical Writing and Regulatory Affairs. Global Clinical Research supporting the Clinical Research industry to deal with this rapid growth and ensuring that clinical research is being conducted following ICH-GCP and WHO standards. This is especially important in emerging markets such as Nepal, where there are many investigators willing to conduct clinical trials for the first time. The importance of training becomes a necessity.

Good Clinical Practice Training for Early and Mid-Career Researchers

Good clinical practice is a set of internationally recognized ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. Compliance with this good practice provides assurance that the rights, safety and well-being of trial subjects are protected and that the results of the clinical trials are credible and accurate. The number of epidemiological and clinical trial research is going on in Nepal where our institution is involved. However; there is a lack of quality of research because of the gap in hands-on Good Clinical Practice Training (GCP). This will be the first hands-on training which will be provided to the scientific personal who are involved in surveillance as well as clinical trial study from the Nepalese institution

Clinical Research Operations

The course will explain the basic principles for the design of clinical trials and how they should be reported.  Participants will be introduced to terminology used in clinical trials and the several common designs used for clinical trials.  We will also explain some of the mechanics of clinical trials, like randomization and blinding of treatment.  In the second half of the course, we will explain how clinical trials are analyzed and interpreted.  Finally, we will review the essential ethical consideration involved in conducting experiments on people.

Medical Writing

Medical writing is the activity of producing scientific documentation by a specialized writer. The medical writer typically is not one of the scientists or doctors who performed the research. A medical writer, working with doctors, scientists, and other subject matter experts, creates documents that effectively and clearly describe research results, product use and other medical information.

The medical writer also makes sure the documents comply with the regulatory, journal, or other guidelines in terms of content, format and structure. Medical writing as a function became established in the pharmaceutical world because the industry-recognized it requires special skill to produce well-structured documents that present information clearly and concisely. A growing number of new drugs go through the increasingly complex process of clinical trials and regulatory procedures that lead to market approval. This drives demand for well written, standards-compliant documents that science professionals can read and understand easily and quickly.

• Regulatory Affairs
• Clinical Data Management
• Pharmacovigilance
• Quality Assurance