Clinical research is defined as a type of systematic study for presenting new medications in human subjects to further investigate and verify the Clinical, Pharmacological or even adverse effects with the aim of determining the efficiency and safety provided by the newly introduced drug.
Clinical research rate has largely grown all over the world in few years. It has also provided a vast area for employment to a large number of people. The markets assigned for Clinical Trials are worth more than US$ 45 billion all over the world and the employers employed for this cause are estimated upto 2,10,000 in United States and upto 70,000 in United Kingdom forming one-third of the total staff working in Research and Development. These large rates of employments are justifying the fact that this area has successfully provided a large number of employments.
Clinical Research Coordinator (CRC)
All the clinical trials are held under the responsibility of Clinical Research Coordinator in the light of Good Clinical Practice (GCP) and Principal Investigator (PI).
- All the trials and researches are conducted legally as mentioned in the Declaration of Helsinki.
- Science prevails all the rights and safety of the patients.
- Trial can be supported by any clinical or non-clinical information or by any investigating agent.
- All trials are to be scientifically approved and well described.
- Institutional Review Board approvals are necessary for all the trials.
- It is the responsibility of all the medical practitioners to take care of medical decisions.
- All the employers involved in the clinical trial must be well educated and well trained.
- All the documents regarding study must be recorded and stored for accurate reports and verification procedures.
- Systems which assure the quality of Clinical trial are utilized.
Clinical Research Associate
Clinical Research Associate (CRA) is one of the most important component in the process of designing and monitoring the clinical trials and then preparation of relative medical reports, Investigational Device Exemptions (IDE) reports, New Drug Application (NDA) reports and a lot more. It also plays a role in the writing and formatting of case reports and consent forms during the clinical trials. It is also responsible for the planning of all steps which are required to carry out some complex clinical trials and to make sure that Good Clinical Practices (GCP) are being followed. They conduct visits at the sites, pre-study the researches and monitors all the activities which are being done. They make sure that whether the Case Reports Forms (CRF) are being reviewed on time and are being submitted to the group of data management or not. Also involved in the compiling of medical reports of INDs, IDEs etc. Furthermore, it is also employed in the preparation of presentations for scientific meetings and technical journals. Attend those scientific and professional meetings to make sure that everything is done accurately or not.
By all these efforts the quality of medication has proved to be far more better than before. The actual reason behind this difference is that these all facilities of Clinical researches were not available at that time and we are fortunate to enjoy all these facilities.