Leading the Way in First-in-Human Clinical Trials with Precision, Safety, and Innovation
Our state-of-the-art facility specializes in First-in-Human and First-in-Man clinical trials, upholding the highest standards of safety and accuracy. With a robust database of qualified participants, and a strong emphasis on innovation and regulatory compliance, we offer a controlled, highly regulated environment that guarantees reliable, reproducible study outcomes. Our Phase I capabilities span various therapeutic areas, including clinical pharmacology, special populations, healthy volunteers, PK/PD, and biopharmaceutics. We conduct early-phase trials with precision, optimizing drug absorption, metabolism, and delivery. Additionally, our team is dedicated to generating high-quality data that accelerates drug development and regulatory approvals. Through this expertise, we drive medical advancements while ensuring safety and efficiency.
- First-in-Human (First in Man)
- SAD and MAD PK Studies
- Healthy vs. Patient population
- Drug Interactions
- Cardiac Safety (e.g. TQTc study)
- Renal Impairment
- Hepatic Impairment
- Diabetes
- Age, gender, etc.
- Dose selection
- Efficacy vs. Safety
- Bioavailability/Bioequivalence (BA/BE)
- Food Effect
- Bioavailability/Bioequivalence (BA/BE)
- Ascending Dose
- QT/QTc Safety
- PK/PD
- Food Effect (Fed/Fasted)
- Vaccines
- Drug-to-Drug Interaction
- Maximum Tolerated Dose
- Drug Transfer
- Single/Multiple Dose
- Patch Testing
- Devices
- Hepatic impairment
- Hepatic impairment, including, but not limited to, Hepatitis A, B, and C
- Hepatic classifications as Child-Pugh A, Child-Pugh B, and Child-Pugh C (mild, moderate, and severe)
- Renal Insufficiency
- Classification as Mild, Moderate, and Severe, including Dialysis
- Type I Diabetes
- Type II Diabetes
- Elderly
- Hypertension
- Pre/Postmenopausal
- Obesity
- Immunology
- Plaque Psoriasis
- Rheumatoid arthritis
- Lupus
- Cardiology/Vascular Diseases
- Dermatology
- Endocrinology
- Gastroenterology
- Hematology
- Hepatology (Liver, Pancreatic, Gall Bladder)
- Immunology
- Infectious Diseases
- Musculoskeletal
- Nephrology
- Neurology
- Nutrition and Weight Loss
- Obstetrics/Gynecology (Women’s Health)
- Oncology
- Ophthalmology
- Orthopedics
- Otolaryngology (Ear, Nose, Throat)
- Pediatrics
- Podiatry
- Psychiatry/Psychology
- Pulmonary/Respiratory Diseases
- Rheumatology
- Urology
- Vaccines
Phase I services, Healthy Volunteers, Special Population
Phase I services, Healthy Volunteers, Special Population

Location:
2950 NW 83rd St, Miami, Fl 33147
Hours of Operation:
Monday - Friday 8:00am - 4:30pm
Main: 305-220-2727