The Food and Drug Administration (FDA) and local governing bodies across the world require that all Investigational medications and devices be thoroughly tested for safety and effectiveness before your doctor can prescribe them. Clinical research organizations like Global Clinical Research Services conduct clinical research to assess how a medication is absorbed and eliminated from the body, and its tolerability and safety prior to FDA submission, federal approval and market release.

In clinical research trials, study volunteers receive investigational treatments (medication) while doctors and the research staff oversee their care and closely monitor how the treatments affect them. In a clinical trial, information is collected from participants who are treated with study medications and then reported to the sponsor and FDA.

Prior to human testing, an Institutional Review Board (IRB), often consisting of religious, legal and medical professionals, evaluates the appropriateness and purpose of all studies to be conducted. The IRB serves to protect the rights and welfare of research trial participants by pre-approving all research activities, including the protocol, documents, procedures and advertising.

The IRB ensures that the consent form is accurate and easy for the volunteer to understand. Informed consent refers to the process by which volunteers are informed of the details of the trial, which is required from each individual prior to being admitted into the trial. Volunteers must be provided with all the facts about the trial, including possible risks and benefits, prior to giving consent to participate. As a volunteer, you have the right to refuse treatment or remove yourself from the study at any time, for any reason.

Participant safety is the number one priority of any study.

Each participant is given a consent form to sign that describes the most common risks for the medication being studied and the potential benefits of participating in the study. You will be able to discuss the informed consent with the research staff. They will help you fully understand the risks and potential benefits of participating in the study and your rights as a research participant. Your medical condition will be monitored throughout the study by experienced research staff and physicians. Participation in a clinical trial is voluntary, and you can withdraw at any time.

Participating in a clinical trial is much like a regular visit to a doctor’s office, hospital, or medical clinic. Participants are treated professionally and with care.

During a clinical trial, study medication is administered. Also, tests and procedures are performed according to a research protocol, which has detailed guidelines that the research staff and physicians follow. The research protocol is designed by the study sponsor to measure the effectiveness and safety of the study medication or procedures.

As a qualified participant for clinical trials:

• You may be benefiting your future and the future of others by helping with the evaluation of new medications.  

• All procedures related to the study are free of charge. Those may include physical examinations, doctor visits, dietary counseling, study medications, and laboratory tests.

• You may have the opportunity to receive a new research medication for the treatment of your condition.

You may learn more about your condition or disease and the latest treatments available.

Click here to get more information on your Medical Condition and Study center information to participate in the Clinical Study.

You may discuss your participation in the clinical trial and continue to see your own doctor for all non-study related medical matters.

At your request, our staff can keep your doctor informed about your participation in the study.