Therapeutic Areas

Cardiology/Vascular Diseases
Dermatology
Devices
Endocrinology
Family Medicine
Gastroenterology
Hepatology (Liver, Pancreatic, Gall Bladder)
Internal Medicine
Musculoskeletal
Neurology
Nutrition and Weight Loss
Obstetrics/Gynecology (Women’s Health)
Pediatrics/Neonatology
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Rheumatology
Urology
Vaccines

Center Overview

The company in USA was established as continuation of a very successful research department in a private hospital in Bulgaria, Europe- Akta Medika, that provides medical care to a population of 160,000 people. The center there is currently involved in more than 20 industry sponsored clinical trials with past participation in more than 30 successfully finished trials. Its Research Manager – Dr Boris Nikolov established the department in 2009 and after successful implementation of SOPs and control procedures in 3 years was decided to open a clinic in USA, which started as a research center at a Family Medicine private practice in March of 2012 with the help of Dr Mario Coto, MD, a physician with 30 years of experience in medicine and involvement in research since 1992. The operation is expanding recently to adding more research experienced physicians to develop a network of qualified physicians to serve as Principals Investigators and capable research coordinators to perform clinical trials at different sites in Miami.

Performance Metrics

Number of Studies Conducted: 4
Number of Studies Actually Completed: 3
Number of Active Patients in the Database: 3000+
Regulatory Submission Turn-Around Time: 1 Week(s)
Average Number of Total Patients Enrolled: 20
Average Percent of Total Patients Randomized: 90%
Average Percent of ‘Completed’ Studies that met Enrollment Goals: 97%
EDC Capabilities: Yes

Clinical Research Experience

Pulmology – Asthma, COPD

Endocrinology – 2 trials in Diabetes type 2 patients with cardiovascular diseases, phase 3

Researchers from the center have worked with the American Academy of Family Physicians, Research Network and Harvard Institute of Clinical Research. Sponsors like Quintiles, WWCT, Covance, Roche, INC Research, Astra Zeneca, Convex, Innovacell, Eli Lilly, PPD and Takeda.

Facility Description

• ambulatory outpatient services
• ECG
• Spirometry
• Weight Scale
• Centrifuge
• Controlled recorded temperature Freezer
• Controlled recorded temperature Refrigerator
• Locked storage, controlled recorded room temperature
• Blood pressure equipment
• High Speed internet access

Investigator Experience

PI - Mario Coto, M.D.
Pulmology, Gastroenterology, Cardiology
Clinical trials phase 2, 3 and 4

Dr. Evelyn Lopez Brignoni M.D.
Child and Adolescent Psychiatry
Various trials in depression, bipolar disorder, anxiety

Dr. Jeffrey Kamlet, M.D.
Internal Medicine, Pain Management, Addiction Medicine
Participation in various trials in pain management, depression, COPD

Dr. Guillermo Llosa M.D.
Pediatrics
Participation as sub-investigator in various trials in constipation, asthma in children

Staff Expertise

Dr. Boris Nikolov, FMG, CCRC - Foreign medical Graduate, 12 years experience in clinical research, 18 years in the medical field, 3 years experience as a Sub-Investigator in more than 40 industry sponsored trials in rheumatoid arthritis, diabetes type 2, asthma, COPD, GERD, stress urinary incontinence, epilepsy, skin infection, diabetes with CVD, hypercholesterolemy, ankylosing spondilitis, back pain, osteoporosis, allergic rhinitis

Aimee Cabo - CRC, BSN - 4 years experience in clinical research – trials in COPD, asthma, diabetes type 2, rheumatoid arthritis

Patient Demographics

Adult patients above 18 years old
Large database of patients with Asthma and COPD
Pediatric patients since the end of 2012 as we started working with Dr Llosa, a pediatrician

Other Information

Central IRB

Contact Center

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the email form below. A representative from the research center will then follow up with you.

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