Sponsor / CRO Information

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.

Site Capabilities Include

  • ECG Machines
  • Pulmonary Function Test Equipment
  • -20 Freezer
  • -70 Freezer
  • Centrifuge
  • Refrigerated Centrifuge
  • 6 Bedroom Accredited Sleep Lab
  • Sophisticated Temperature Remote Monitoring System with Alarm
  • Double Locked Dedicated Drug Storage Rooms (2)
  • Dedicated & Comfortable Monitor Rooms
  • Classroom for Patient Education of our Clinical Trials & Support Groups
  • Wi-Fi
  • Dedicated Copiers/Fax Machines in our spaceous Monitor Rooms

Regulatory Work & Queries

Are typically turned around within 24 to 48 hours.

Contracts & Budgets

Are typically executed within 2 to 3 weeks from initial receipt of the documents, to final signatures by the site. We typically counter within 24 to 48 hours from the initial receipt of the documents.

Patient Recruitment

The majority of our subjects are recruited from our Investigators’ private practices; consisting of thousands of names of subjects with the various conditions that we conduct research in. Our EMR capabilities allow us to identify subjects quickly, therefore we typically randomize shortly after Site Initiation. Additionally, because we know our subjects well, we have a high retention rate, as well as low early withdrawal rates.

Our Team

Our team has been together for many years, so you can expect low staff turnover during the conduct of your clinical trial. We are also fortunate to have as part of our Clinical Trials Team a dedicated full time recruiter who helps us scout our extensive database of COPD, Asthma, Diabetes, Cough, Sleep Apnea, Insomnia, Narcolepsy, and Pulmonary Fibrosis patients.

Clinical Trial Experience

We have experience conducting long term studies, trials with overnight stay requirements, serial spirometry, serial PK’s, as well as Phase I-IV complex protocols with tight deadlines.

Industry Knowledge

We are highly proactive in the clinical research industry, and attend all major industry meetings taking place in various parts of the country. We are a proud member of SOCRA, ACRP and Drug Information Association (DIA).