Course Overview
9h 22m | 65 Videos | 75842 Views | 
Beginner eduCBA brings you the course on Clinical Research.
Clinical Research is one of the most knowledge-intensive industries. It is complete biography of drug from its inception in the lab to its introduction to the consumer market and beyond. Any molecule is identified is subjected to pre-clinical and clinical trials before entering in to market. Though post marketing surveillance is also part of the same. Pre-clinical studies are associated with effect of drug on animals. All the toxicological studies, tests for teratogenicity, carcinogenicity are carried out. After this, the data obtained from the studies are submitted as an IND (Investigational Drug Application) to take permission for human studies. Then, it is enter in to clinical trials. There are 4 phases in it.
SCOPE-
It is very clear that India has become a very preferred destination for clinical research. The industry is growing exponentially and is expected to reach Rs. 7000 Cr by 2010. Statics shows that if India’s clinical trial business grows to 10% of that in US by 2015, the industry will need approximately 50,000 clinical research professionals.
Any professionals from CRO (Clinical Research Organisation), Pharmaceutical, biotech, practising doctors and fresh graduates can apply for it. Salary states are high. As around 700 Cr. expenditure is there for single research.
Any branch on your own interest has greater opportunity. Right now Pharmaceutics and pharmacology has greater scope. Also pharmacognosy people as Herbal Industries are booming in India. But choosing branch or subject on your interest is more beneficial as one can give free flow of thoughts and also new innovations. So, demand is there for all branches but only on one condition that you have basic to the latest knowledge.
Target Customers for this course:
- Students
- Professionals
Pre-Requisites for this course:
- Basic Computer Knowledge
- Passion to learn
- Any Science Graduates/ postgraduates / doctors
Course Objective:
- Clinical trials are prospective biomedical or behavioral research studies on human subjects that are designed to answer specific questions about biomedical or behavioral interventions (novel vaccines, drugs, treatments, functional foods, dietary supplements, devices or new ways of using known interventions), generating safety and efficacy data.
- They are conducted only after satisfactory information has been gathered that satisfies health authority/ethics committee approval in the country where approval of the therapy is sought..
- Depending on product type and development stage, investigators initially enroll volunteers and/or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. As positive safety and efficacy data are gathered, the number of patients typically increases. Clinical trials can vary in size, and can involve a single research entity in one country or multiple entities in multiple countries.
- A full series of trials may cost hundreds of millions of dollars. The burden of paying is usually borne by the sponsor, which may be a governmental organization or a pharmaceutical, biotechnology or medical device company. When the required support exceeds the sponsor’s capacity, the trial may be managed by an outsourced partner, such as a contract research organization or an academic clinical trials unit.
