Our office has established a state of the art Clinical Research Center offering an expanded list of clinical research and development services to established companies and start-up entities in the pharmaceutical, devices, nutraceuticals, over the counter, consumer products, and cosmetics arenas.
Our goal is to help improve people’s lives by helping bring revolutionary new products and services to the market, that improve quality of life and address unmet need around the world. In a heavily regulated environment, we work diligently under the hospices of Good Clinical Practices (GCP), while adhering to science-based research.
The newly established New Jersey Clinical Research Center is operated by Dr. Barry DiBernardo, New Jersey Plastic Surgery with collaborations from Trial Management Consulting Group LLC. Together, we put medicine, quality and compliance in everything we do.
Clinical Research are used to evaluate the effectiveness and safety of a new product or device not yet approved for marketing. Such research provides for the information needed to support the approval of a product into the marketplace. In human, research helps healthcare professionals identify mechanisms of action, product performance and safety in ways the animal or lab testing model can not provide.
Why Should I Join A Clinical Trial?
Clinical studies (or in human testing) require volunteers from diverse populations be included (i.e., gender, age, demographic location, ethnicities, etc) in order to obtain well represented product exposure and results. By volunteering to participate in a research study, you can:
- Benefit society by helping researchers find better treatments for you and others in the future
- Help researchers discover better ways to fight diseases or address unmet need
- Help researchers determine if a product(s) is safe for human use/exposure
- Help researchers understand how different people process medicines or products in different ways
What are the risks?
The products being tested may be a new product entity (i.e., drug, technology, cosmetic product, or nutrient) thereby the safety profile is unknown and may result in expected or unexpected side effects. In other instances, a marketed product may be used in a clinical study to test its equivalence to a new product, or to evaluate a new formulation for a new indication. In rare cases, side effects can be serious or even life-threatening. It is important to know that all expected or unexpected side effects are closely monitored and managed by the study doctor until the event resolves or stabilizes.
In summary, the treatments being tested typically have not yet received FDA approval for sales and marketing.
Do I Qualify For A Clinical Trial?
In clinical research, every study is different in what is being tested and why therefore, each study will be driven by a set of eligibility criteria that must be met in order for a subject to qualify for a study.
After evaluating for studies that have “Open Enrollment” status, the study doctor, or a designated study staff member will perform a review of the study in detail and respective eligibility criteria for the study, in order to determine if you qualify. This is called the consenting process where you will have the opportunity to ask questions to see if you still want to take part in the study.
How Many Office Visits Should I Expect?
Study visits are dependent on study requirements. Your study doctor or designated staff member will present this information during the consenting process to help you decide if you wish to participate in the study.
What Kind Of Clinical Trials Are Available?
Clinical trials vary greatly and there are always new research opportunities available to our patients. Please visit our “research” tab for information on clinical studies with “Open Enrollment” status.