We can never tell you a medication is safe, but we can guarantee your safety is the number one priority of all PRC clinical trials. Our research team of doctors, nurses and health care professionals monitor your health state very closely during your participation. We are prepared for side effects that may happen and for those that are unexpected. You have direct access to research doctors and nurses who are watching test results, evaluating how you’re feeling and assessing all aspects of your health. The first time you take a new medication, approved or investigational, it is new to your body with unknown results. When you participate in a clinical trial we are hand in handwith you every step of the way throughout your entire clinical trial experience.
Prior to agreeing to participate in a trial you are fully informed of the clinical trial, including the potential benefits and risks, trial design, procedures to be completed, investigational product dosing and administration. We assure that you understand the entire research process before you can freely agree to participate in the study.
Before you ever begin a clinical trial you will go through certain medical exams during a “screening period” to make sure you’re healthy enough to take part. During the trial research doctors, nurses and other health care professionals will carefully monitor any changes in your health. If you experience any unexpected effects or if your condition worsens, you may be taken off the study for your safety. You may also choose to stop participating for any reason at any time. You are volunteering to participate.
Every clinical trial protocol, which is a strict guidance of how the physician will conduct the clinical trial, is review and approved by the Independent Review Board (IRB) and regulatory authorities (FDA) prior to starting a clinical trial.
The research is managed and conducted by an educated, experienced and qualified research team following FDA regulations and ICH GCP guidelines to further ensure the oversight of your health during clinical research participation.
You participation is entirely voluntary and you are free to stop the research trial at any time without any negative consequences.