Unite Clinical Research Consortium (Unite CRC) is a clinical research network specialized in the conduct of clinical trials sponsored by the pharmaceutical, biopharma, and medical device industry. Our physician network is committed in providing the highest quality process improvement; clinical safety & effectiveness service to our patients participating in medical research. We welcome you to visit us in person to determine your next clinical trial with our network that is fully capable to comply with any related protocol and regulatory compliance requirements.
Developing a new medicine begins with understanding the disease or condition as thoroughly as possible. Basic research provides clues about how to treat diseases and potential ways to target the symptoms or underlying causes. Once researchers have completed a rigorous screening and preclinical testing process, the pharmaceutical company files an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) to allow the investigational drug to be tested in human volunteers in clinical trials. A clinical trial is a study carefully designed to test the safety and highest effectiveness of a specific medical treatment or intervention, such as a new drug or a behavior change. Every clinical trial is led by a Principal Investigator (PI), who is usually a physician, a research team that consist of nurses, clinical research coordinators, clinical research associate, a clinical research trial manager, and research assistance. The daily operational activities as well as administrative activities are performed by service line management personnel.
Confidentiality Disclosure Agreement (CDA) may also be referred to as a Nondisclosure Agreement (NDA) or Confidentiality Agreement. The purpose of this type of agreement is to ensure that confidential information belonging to a party (or parties) to the agreement is protected. The sponsor will not provide the site with any proprietary information (the protocol) until this is executed. The Sponsored Programs reserve the right to review and negotiate language if necessary. Once the physician signs the CDA, we can answer any and all questions and explain the process of how he/she can become involved with us in participating in a clinical trial. This CDA requirement is made by the pharmaceutical companies.
A Pre-Study Contact is then completed to confirm suitability of investigator and site to conduct research study, to communicate sponsor expectations regarding general conduct of the study and to ensure all regulatory, IRB and Good Clinical Practice (GCP) requirements have been met.
The purpose of creating Unite Clinical Research Consortium is to be able to work with all patient communities and physicians to get them involved in the development of new medical treatments specifically targeted to at risk populations within the United States. Our goal is to expose patients to cutting-edge treatment options asking for their participation and benefits, regardless of their ability to pay or health insurance policy.