Clinical Research is an important professional discipline just as Regulatory Affairs. It deals with the art of designing experiments and carrying them out to determine if health products such as new drugs or medical devices are safe and effective for use in health care.
Regulatory professionals require a certain amount of knowledge in Clinical Research as they depend on reports based on clinical research during the application for product licensing. Furthermore, Regulatory professionals advise pharmaceutical companies on the governments’ requirements at different stages during drug development.They should therefore have working knowledge of clinical research. Regulatory professionals do not require as much knowledge in clinical as much as the clinical research professionals. They however need enough knowledge to practice as regulatory professionals.
Regulatory affairs personnel for USA market need to submit an investigational new drug application abbreviated IND for approval before clinical trials can start. Similarly for the Canadian market, a clinical trial application (CTA) must be submitted to therapeutic products directorate for approval before a clinical trial can start. The type of training you will need depends on your market.
If your market is only in Australia or France, there will be no need to learn requirements of sub North America. However, there are certain guidance documents which apply to all regions. They are mainly documents from the International Conference on Harmonization (ICH).
People in the field of clinical research can work in several areas including:
• Clinical trial monitoring
• Coordination of clinical trial activities
• Protocol writing
• Quality control
• Protocol writing
• Site inspections/audits
• Clinical report writing
These specialties may sometimes be outsourced from specialized departments or consultants.
If you are thinking of training in clinical research, we may be able to help you. We also provide consultancy services in some of the specialties mentioned in the above listing. We however focus on the North American market.
