Clinical Trials of Florida, LLC, is a Phase I-IV clinical research site with overnight capabilities and an American Academy of Sleep Medicine State-of-the-Art accredited sleep lab. We focus on respiratory medical research, sleep trials, and endocrinology studies for interventional, observational, and device medical research.
Clinical Trials of Florida, LLC, is directed by Dr. James P. Krainson and Ana T. Marquez, MSF. Both Dr. Krainson and Mrs. Marquez share their passion for conducting clinical trials. They take pride in producing quality data, enforcing a quick turnaround time for the resolution of queries, and require all staff members to obtain their ACRP certification, within two years from employment at Clinical Trials of Florida.
Dr. James P. Krainson, a University of Miami graduate has established himself as one of the “Top Physicians In America”, and is nationally recognized for his expertise in the field of Sleep Medicine. Dr. Krainson also heads a Fellowship Program for Physicians obtaining their training in Sleep Medicine. Additionally, he practices Pulmonary Medicine, and conducts medical research in Sleep, Respiratory, and Endocrinology clinical trials.
Ana T. Marquez, MSF, serves as Research Director for Clinical Trials of Florida, LLC. She has also helped sites across the United States with varying therapeutic indications and Phases, improve their site processes. Furthermore, Mrs. Marquez has been involved in helping clinical research sites with FDA inspections, Sponsor and IRB audits. Mrs. Marquez serves as the Chairman on Drug Information Association’s (DIA) SIAC Committee for Investigative Sites, and also serves as Chairman for the Membership Committee of The Society for Clinical Research Sites (SCRS), a national organization representing the voice of hundreds of sites globally.
Additionally, Mrs. Marquez mentors Research Directors, and new Principal Investigators in their conquest to build superior clinical research facilities, as well as those seeking to improve their existing site processes. She has been praised for her quality control program, her overall knowledge of clinical trial operations, and is recognized amongst sponsors who conduct Phase I-IV pulmonary clinical trials.
There are many reasons to participate in a clinical trial! Clinical trials are where new treatments are tested before they are made available to the general public. While participants of clinical trials cannot be assured of treatment, there are often many other benefits associated with participating.
Participants are closely followed by board-certified physicians, gain new knowledge about their condition, receive diagnostic tests and labs at no cost, and help advance medicine by providing valuable data for the research study. Additionally, participants are often compensated for their time devoted to participation.
See the FAQs below to learn even more about clinical trials and the value of participation.
Frequently Asked Questions (FAQs):
A clinical trial is a research study designed to provide valuable data for a new or existing treatment, or treatment method, to determine if it is safe and effective for humans. In order to determine if a treatment is both safe and effective, testing must be conducted to provide statistical proof. According to laws and regulations, all clinical trials must be reviewed, approved and monitored by an Institutional Review Board (IRB) to ensure the ethical treatment of participants, and to ensure that all participants are fully informed about the study prior to agreeing to participate.
Every clinical trial has specific criteria related to the type of participants that are needed for the study. These criteria exist to ensure that good statistical data can be collected for the study to achieve its purpose. Additionally, in order to ensure that no undue risk or coercion is placed upon study volunteers, certain populations are considered special populations that must receive a higher degree of safety and ethical oversight. These populations include children/minors, pregnant women, indigents, prisoners, and other vulnerable populations.
The very first thing that will happen if you choose to volunteer for a clinical trial is you will be provided a full explanation of the study including required tests and procedures, visits that you have to attend, as well as potential risks and benefits of the study. If you agree to participate in the study, you will always be able to stop participating at any time. While in the study, you will only be asked to complete the visits and procedures that were specified in the beginning. The goal of the study is to collect valuable data from you that will help the researchers during the study.
Without clinical trials, all of the medications and treatments that we have today would not exist. In order to develop new treatments that are both safe and effective, testing must be done. The Food and Drug Administration (FDA) requires that all medical treatments or methods be vigorously tested to ensure that they are both effective and generally safe. Volunteers of clinical trials provide a valuable service to the community to help researchers advance medical science and improve healthcare for generations to come.
Volunteers are always fully informed of the study requirements, required visits, tests, procedures, etc. Additionally, volunteers are always made aware of any known or likely risks of a study or any new risks that are discovered during the study. Volunteers should ask as many questions as they need in order to feel comfortable with participating. Make sure that you know exactly what will be required of you and that you are willing to perform the required tasks in the study. Also make sure that you understand the benefits and risks of the study and that you can accept the risks of participating. You may also request to speak directly with the principal investigator of the study, and you may want to discuss the study with your primary care physician (PCP) prior to agreeing to participate.
YES, participation in a clinical research study is always voluntary and optional, and you can stop participating at any time. Ethical laws and regulations prevent participants of clinical research studies from being given undue influence or from being coerced into participating or continuing to participate.