Supreme Clinical Research Management
Human subject protection and data integrity is our major objective.
One of the goals is to disseminate new knowledge and practices to the community
What is Clinical Research?
Clinical research is a systematic investigation which involves study on human volunteers that is intended to improve medical knowledge. The research study is conducted to find new ways in understanding, preventing and treating medical illnesses. The Knowledge of certain conditions like Parkinson’s disease, cancer and other medical illness have rapidly improved over the past decade due to extensive clinical research on these conditions. Similarly certain vaccines have been developed which may prevent diseases.
Who Conducts Clinical Studies?
Every clinical study is overseen by a principal investigator, who is often a medical doctor. Clinical studies also have a research team that may include doctors, research nurses, research assistants, data managers, social workers, and other health care professionals.
Clinical studies can be conducted by private physicians or physicians in academic medical centers. These studies may be sponsored by pharmaceutical companies, academic medical centers, voluntary groups, and other organizations like National Institutes of Health, U.S. Department of Defense, and U.S. Department of Veterans Affairs.
Can I Participate in a Clinical Study?
Clinical studies have standards outlining who can participate, called eligibility criteria, which are listed in the protocol. Some research studies seek participants who have the illnesses or conditions that will be studied. Other studies are looking for healthy participants. Talk to your Physician to decide if you may be eligible for a clinical trial.
Are there any risks involved if I participate in Clinical Research?
The medication or device used in clinical trials can cause adverse effects depending on the type of medication used. Since new medications are used, the risks are not always known ahead of time, the investigator monitors the adverse effect to decide if the adverse effect was related to the new medication or not. The patients will be explained before enrollment the known adverse effects of the medication based on available knowledge.. Your Physician will discuss the risks and benefits, alternate medications and other available options for your medical illness before starting the therapy. If you agree with your physician and willing to take part in the clinical study, you will be asked to sign an informed consent, which is a form which explains the details of the treatment, risks and benefits and available options. You may withdraw from the clinical study at any time for any reason. Your treatment will not be compromised if you decide to withdraw from the study.
How am I Protected?
Each clinical study whether a drug or device is regulated by FDA and must be reviewed, approved, and monitored by an institutional review board (IRB). An IRB is made up of physicians, researchers, and members of the community. Its role is to make sure that the study is ethical and the rights and welfare of participants are protected. This includes making sure that research risks are minimized and are reasonable in relation to any potential benefits, among other things. The IRB also reviews the informed consent document.
In addition to being monitored by an IRB, some clinical studies are also monitored by data safety and monitoring boards (DSMB)
Various Federal agencies, including the Office of Human Subjects Research Protection (OHRP) and FDA, have the authority to determine whether sponsors of certain clinical studies are adequately protecting research participants.
How can I participate in a clinical study?
Please email firstname.lastname@example.org or call 860-874-6948. We will ask few questions to check the eligibility criteria. If you meet the basic criteria you will be asked to visit the clinic and a study coordinator will evaluate you before you see the physician.
How much will I be paid to participate in the clinical research?
Study participation is on a volunteer basis, we do not pay you for enrolling on a study. Study volunteers may receive free tests and study medicines, an opportunity to learn more about various medical conditions, and possibly receive financial compensation for time and travel.