Our Mission is to provide the best possible care to our patients in an atmosphere of excellence, compassion, integrity, and innovation.
Our vision is to be recognized as the leading center for clinical trials in United States.
Our objective is to obtain and provide the most accurate and reliable scientific data, while preserving and protecting the welfare, rights, and safety of our patients.
Our duty to our sponsor is to conduct clinical trials with precision, reliability, and integrity. This is achieved by our unique system of accurate data collection and rapid query resolution, while maintaining the safety and rights of our study participants. We strictly adhere to our internal SOP, GCP, study-specific protocols, and IRB Guidelines.
Our sponsors can be assured that the reputation, prestige, and expertise of our institution enhance the credibility and publicity of their trial results. Close adherence to study protocol and timelines is paramount.
CCCR staff includes skilled clinical research coordinators; registered nurses; certified phlebotomists; patient recruiters, and psychometric raters.
Our center facilitates immediate turn-around times for regulatory document submissions. Study-specific worksheets are generated and carefully designed according to the protocol, enhancing QA data and minimizing queries. Our Quality Assurance Department reviews data on a regular basis.
A clinical trial is a study in human volunteers designed to answer a specific health question about the safety or efficacy of a drug, a device, or other interventions. These allow doctors to examine the benefits and risks of using these drugs. Clinical trials are designed to find safe treatments that work in people and new ways to improve health.
People choose to participate in clinical trials for many reasons. Clinical trials can either enhance treatment, or be a treatment option. Some people seek clinical trials when other treatment options have not been successful. Here are a few reasons people choose to participate in studies:
First, you will be given a consent form, which explains what is involved in the study. Members of the research team will review this form with you and will answer any questions you have about the study. If you decide to be in the study, you will sign the consent form. Being in a study is completely voluntary, and you can change your mind at any time even if you have signed the consent form. The consent form information is based on a carefully controlled protocol, which is a detailed plan of what will be done in the study. All studies have guidelines about who can participate. The guidelines are called inclusion and exclusion criteria. The guidelines or criteria are not used to reject interested participants personally, but to help produce reliable study results. You will be monitored carefully during the study, and you will likely be contacted by the research team after study procedures are completed. Some studies require more tests and doctor/clinic visits than you would normally have for an illness or condition.
US federal Agencies including the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) oversee much of the clinical trials in the U.S. to protect the rights and welfare of study participants. Institutional Review Boards (IRB) oversee the centers where clinical trials are conducted. IRB review and approve study protocols to ensure that a clinical trial is ethical and that study participants’ rights are protected. You, as a study participant, have access to the IRB overseeing the clinical trial, including access to a volunteer advocate, the physician and staff conducting the clinical trial.