A clinical research study or trial is a scientific study for evaluating a new treatment that has shown promise in laboratory and animal studies. It is a scientific study of how a new medicine or treatment works in people. Through clinical studies, doctors find new and better ways to prevent, detect, diagnose, control and treat illnesses. This testing in humans is permitted only if everyone who volunteers for participation understands the risks and benefits of taking part in a study.

Many years are spent testing medications in the laboratory and in animal research to determine the medication’s safety and usefulness before clinical trials are conducted to determine the medication’s effect on humans. The Food and Drug Administration (FDA) requires clinical trials on all medication before they will approve a medication for public use.

A clinical investigator is a medical researcher in charge of carrying out a clinical research study’s protocol. This person is usually a doctor or pharmacist, but can be a nurse or other health care professional. He or she follows a protocol, a carefully designed, detailed study plan created by the study sponsor.

The clinical research coordinator is a health care professional who, under the supervision of the clinical investigator, submits all research documents to the Institutional Review Board (IRB), coordinates all the tests and procedures for the study, and schedules and implements the study visit requirements.

The IRB is a group of health care professionals and community members from the institution where the research study takes place. This group makes sure all FDA and protocol regulations are followed and reviews all research study activities, including recruitment and advertising, and potential risks.

The study sponsor is the pharmaceutical company, research institution, or other health organization that funds a clinical research study and designs its protocol.

Rochester Clinical Research works directly with sponsors, and with the Clinical Research Organizations (CROs) they sometimes hire to conduct clinical trials and provide other drug development services. We also collaborate with Central Recruiting Vendors (CRVs) that specialize in patient recruitment for clinical trials. We like to use the word for the sponsors, CROs and CRVs with whom we work. Find out more on the Partner area of our desktop website.