Pharmacovigilance begins with clinical trials that provide data on the benefits and risks of a drug. The aim of pharmacovigilance in clinical research is to determine if the benefits outweigh the risks; if they do, drug manufacturers take steps to gain approval to market the new drug.Phase I, II, and III clinical trials are needed before a drug company can apply for a new medicine’s market authorization. In these studies, the principle investigator is the main point of contact at the trial site. They are responsible for the conduct of the research and then feed it back to the sponsor (the pharma company).During clinical trials, the investigator collects and analyzes data on serious adverse events (SAEs), determining whether the drug in question caused the SAEs. If they conclude that the negative side effects were causal, they are categorized as adverse drug reactions (ADRs).The investigator shares this data with the pharmaceutical company responsible for the drug’s R&D (research and development).