Our Research Center
Nouvelle Clinical Research is a licensed, dedicated clinical research center located in Cutler Bay, Florida, proudly serving a diverse adult population across South Florida. We partner with pharmaceutical companies, biopharma sponsors, and contract research organizations (CROs) to conduct Phase II–IV clinical trials across a broad range of therapeutic areas.
Our team includes experienced physicians, researchers, and healthcare professionals who are passionate about advancing medical knowledge and improving patient outcomes. We specialize in delivering high-quality data while ensuring that every participant receives personalized care and ongoing support throughout their research journey.
At Nouvelle, our mission is to improve lives through innovative clinical research. We are committed to conducting every study ethically, responsibly, and with unwavering scientific integrity, helping shape the future of healthcare while making a meaningful difference in our community today.
Participant Safety
Your Safety Comes First: At Nouvelle Clinical Research, participant safety and ethical conduct are at the heart of everything we do. All clinical trials conducted at our Cutler Bay facility strictly follow federal, state, and local regulations, including guidelines established by the U.S. Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), and Good Clinical Practice (GCP) standards.
Independent Ethical Oversight: Before any study begins, it is thoroughly reviewed and approved by an Institutional Review Board (IRB)—an independent ethics committee responsible for protecting the rights and welfare of participants. The IRB is composed of medical professionals, scientists, and non-medical members of the local community who are not affiliated with Nouvelle. Their sole role is to ensure that our research is ethical, safe, and transparent.
Informed Consent: Know Before You Join: Every participant receives a comprehensive Informed Consent Form (ICF) prior to joining a study. This document clearly explains:
- The purpose of the study and what’s involved
- Who is sponsoring or funding the research
- Information about the investigational treatment or drug
- Potential risks and expected benefits
- Your rights as a participant, including the right to withdraw at any time
- Any compensation or reimbursement offered for your time and participation
Before you sign anything, a trained member of our team will sit down with you to go over the ICF, answer your questions, and ensure you feel fully informed and comfortable.
Health Screening & Medical Oversight: Before enrolling, you’ll undergo a free medical screening, which includes a physical exam, lab tests, and a detailed review of your medical history. This helps us determine if the study is right for you and ensures we’re prioritizing your health and safety from the very beginning.
Supervised by Medical Professionals: Each clinical study is conducted under the close supervision of licensed physicians and trained medical staff. We are on-site and prepared to respond immediately should any unexpected side effects or allergic reactions occur. Your well-being is continuously monitored throughout the trial.
Privacy Policy
Your Privacy Matters: At Nouvelle Clinical Research, we are committed to protecting your personal health information (PHI) with the highest standards of confidentiality and compliance. We strictly follow all applicable federal and Florida state privacy laws, including the Health Insurance Portability and Accountability Act (HIPAA) and FDA regulations that govern research data protection.
How We Protect Your Information
- We collect only the information necessary to determine your eligibility and support your participation in a clinical trial.
- Your data is stored on secure, access-controlled systems, unauthorized access or disclosure.
- All staff handling your information are trained in HIPAA and Good Clinical Practice (GCP) requirements.
Use of Information
Your Rights
- You have the right to review and request corrections to your personal data.
- You may withdraw your consent to participate at any time, and your privacy will continue to be respected.
- Our full Privacy Policy outlines how we collect, use, store, and protect your data, and is available upon request.
- Your information is used solely for research purposes related to the study you participate in.
- We will never share your identifiable information without your explicit, written consent.
- Additional protections are applied to sensitive information such as mental health or HIV status.
Questions
What is clinical research?
- Clinical research involves studies that evaluate the safety and effectiveness of new treatments, medications, and medical devices. Participants in clinical research play a vital role in advancing medical knowledge and improving patient care.
What are the benefits of participating in a clinical study?
- Participating in a clinical study can provide access to cutting-edge treatments, close monitoring of your health, and the opportunity to contribute to medical advancements.
What are the risks of participating in a clinical study?
- As with any medical intervention, there are potential risks associated with participating in a clinical study. These risks vary depending on the specific study and are carefully explained to participants during the informed consent process.
Will I be compensated for participating in a clinical study?
- Yes, participants are compensated for their time and effort in most of our clinical studies. The amount of compensation varies depending on the length and complexity of the study.
How do I know if I qualify for a clinical study?
Eligibility for a clinical study depends on specific criteria, such as age, medical history, and current health conditions. You can review the eligibility requirements for our current studies on our website or contact our office for more information.
What is informed consent?
Informed consent is a process that ensures you understand the purpose, procedures, potential risks, and benefits of participating in a clinical study. You have the right to ask questions and make an informed decision about whether or not to participate.
Is my personal information kept confidential?
Yes, we are committed to protecting the privacy of your personal information. We adhere to all applicable privacy laws and regulations, including HIPAA.
Can I withdraw from a clinical study at any time?
Yes, you have the right to withdraw from a clinical study at any time, for any reason, without penalty.
How are clinical studies reviewed and approved?
All clinical studies are thoroughly reviewed and approved by Institutional Review Boards (IRBs), which are committees of experts who ensure the safety and ethical conduct of research.
How do I contact Nouvelle Clinical Research?
You can contact us by phone, email, or by visiting our office in Miami, Florida. Contact information can be found at the bottom of our website.