This is a general category for clinical research
The clinical research industry is rapidly spreading its wings and is all set to dominate developing countries from all over the world. The focus of this article will be nevertheless, Nigeria, which has a population of above 130 million and is called the “the Giant of Africa” being the most populous country in Africa
The Clinical Research Coordinator (CRC) is a dedicated clinical professional allied with and under the command of a Principal Investigator (PI). Despite the fact that the Principal Investigator is chiefly responsible for the general trial design, conduct, and organization of the clinical study, the CRC assists, and handle the day-to- day activities pertaining to clinical […]
A well trained professional made of sterner stuff can only execute clinical research associate job efficiently and competently. Keeping in view the professional demands, a CRA must have a strong grounding in ethical considerations, international regulatory requirements, clinical trial conduct in agreement with global GCP and an appreciable understanding of allied activities like data management, […]
Clinical trials are performed in a methodically regulated process following some pertinent guidelines formulated by by the International Conference on Harmonization (ICH), which is led by the EU, USA, and Japan. Clinical research education and training is made implicitly mandatory by ICH-GCP highlighting the need for only well educated and qualified professionals to take part […]
Every nation under its Ministry of Health will have dedicated a dedicated governing body to look after every aspect of pharmaceutics and medical devices. India is a vast expanse of varied cultures and diversified population. To know how the regulations in India are presently placed, one should know about CDSCO. What is CDSCO?
Clinical trials in India are governed by rules defined in Schedule Y of the Drug and Cosmetics Rules, 1945. During the revision of Drugs and Cosmetics Rules, 2005, the Schedule Y was comprehensively amended to take the Indian regulations on par with globally acknowledged definitions and measures.
The basic premise to carry out clinical research is to employee well qualified healthcare professionals or clinical research support staff with relevant credentials. According to ICH-GCP well qualified professional must be qualified with respect to education, experience and training. The fundamental principles of ICH-GCP consider a professional with BDS/MDS degrees in the second fiddle to […]
Business Development in clinical research is in the process of a transition. The mounting costs of drug development and rationalizing of concerned departments is lashing many biotechnology and pharmaceutical companies to contract out clinical research programs. This is striking at the matching time as a tendency toward big pharma companies cementing chosen partnerships with a […]
Modern drug discovery and development is highly complicated, and the pharmaceutical industry distinguishes the need for technical know-how among its research, sales and marketing professional work force. Moreover, the area of research and development offers plentiful opportunities for pharmaceutical scientists, including drug isolation and production to formulations, packaging and quality assurance of the finished dosage […]
Before a new drug gets approved in the market by a regulatory authority and is prescribed as “safe and effective when used as directed” it undergoes a series of trials in human beings (of course, before being tested in animals first) which we now know of as Clinical Trials. The whole process takes years and […]