Introduction to various stakeholders in Clinical Research

The regulatory affairs (RA) department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product in the market.

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine/vaccine-related problem.

Clinical data management(CDM) is the process of collecting and managing research data in accordance with regulatory standards to obtain quality information that is complete and error-free.

The goal is to gather as much such data for analysis as possible that adheres to federal, state, and local regulations.

It is a field of clinical research that helps in collecting, analyzing, presenting, and interpreting data.

It helps make decisions concerning the drug’s efficacy, interaction, and line of treatment.

Medical writing is a profession dedicated to the communication of medical, scientific, and health information, including clinical research reports, consumer (patient) information, and the development of clinical trial documents that are protocol, Informed Consent Documents, subject Diaries, etc