Quality &
Safety in
Clinical
Trials

Clinical trials can meet or exceed quality and safety standards when they have strong oversight.

To protect the rights, safety, and well-being of the people who participate in clinical trials, health authorities have established guidelines and regulatory requirements that all clinical researchers must follow. Sanofi adheres strictly to Good Clinical Practice (GCP): an international ethical and scientific quality standard for designing and conducting clinical trials.

Pictured above: Khang Tran, Associate Scientist, mRNA Platform, R&D-Waltham, Massachusetts

Who oversees clinical trials?

Many entities provide oversight of clinical trials. These include the health authorities, independent ethics committees, and data safety and monitoring boards. 

Many professionals oversee different aspects of a clinical study:

  • people from the company or organization that plans, funds, and oversees the conduct of the research (called the study sponsor),
  • the doctors, nurses, and study personnel who conduct the clinical trials, including providing care during the study at the research facility, and 
  • an independent committee of people from outside the study sponsor, called an Ethics Committee. It reviews and monitors clinical trials to ensure the rights and welfare of clinical study participants are protected. 

Who's who in a clinical trial?

Volunteers who choose to participate in a clinical study.

A study sponsor could be a pharmaceutical company, medical institution, federal agency, or another organization that is responsible for, and often funds, the conduct of a research study.

Clinical trials are carried out in research facilities. These could be doctor's offices, hospitals, or clinical research centers. Designated people at the research facilities enroll patients in the study. They are qualified to carry out the clinical trial on behalf of the study sponsor. 

In some studies, telemedicine can take the place of some visits to the research facility. In certain cases, study medication may be delivered to the patient's home. This is different for every clinical trial. 

You will encounter many different professionals when you participate in a clinical trial. The study coordinator is typically the person you talk to the most throughout the study. They carry out the day-to-day study at the research facility. They share what they learn with the principal investigator (PI) – the doctor who is ultimately responsible for the clinical trial at the site.

A clinical trial is overseen by an ethics committee. People on this committee are usually doctors, scientists, and patient advocates. This committee ensures the clinical trial is conducted ethically, and that it is designed to protect the rights and welfare of study participants.


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