Contract Research Organisation

Clinical Research Organisation

What is Clinical Research

Clinical research can be explained as the study of drugs, treatment procedures, and diagnostic devices for treatment and cure of human being. With the evolution of medical science, new drugs have made our life much easier. But, it should be kept in mind that a new drug born in a research lab does not get it place in the market easily. It has to undergo loads of tests just to make sure that it is safe for human use. Various tests are run by clinical research companies to check whether the drug is toxic or not, if it is radioactive and whether it causes any negative side effect or not. Tests on animals are done to check the efficacy of the drug, to determine the dosage that should be administered and any negative effect that can happen due to drug overdose. It is also checked how the drug behaves when used with other drugs, to ensure complete safety of the patients who will be using it when the drug will be marketed.

Research Phases

Generally, the test for a new drug has four phases and it can take many years for a drug to get license to be marketed. Clinical researches are carried out by a clinical research associate whose duty is to perform and monitor the different phases of the clinical trial. The first three phases, i.e. Phase I, Phase II and Phase III. These are the steps that are carried in the laboratory, while the Phase IV of Clinical researches concerns post-approval study.

Jobs in Clinical Research: Noble in True Sense

Clinical research associate is mostly responsible for the tests that are performed. The responsibility that comes with the clinical research jobs is to be taken very seriously. It involves every aspect of the trial of the concerned drug, so that it is safe and free of any hazard when it reaches a hospital or a pharmacy. It includes formulating protocols or methodologies that are to be undertaken to perform the tests and this protocol must be approved by the competent authority. The job also demands speaking to ethics committee and explaining them about the care of the animals that are subjected to experimentation. In some companies, the associate remains involved in the whole process and works side by side of the doctor who has generated the idea of that specific clinical trial. With this job comes tremendous responsibility, as the associate is the person who maintains the data, does the trial monitoring throughout the experiment and discuss about the result with the assigned statistician, who further analyzes and interprets the data. Finally, the associate prepares the reports to be published about the competency of the drug. Clinical research jobs can be highly demanding in nature and the nature of job can vary among different clinical research companies, but the responsibility remains the same. It is unique in nature and one of its kinds, because this leads to production of new drugs and medical techniques helping mankind to survive through acute diseases.