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
At Advanced Pharma, we are passionate about conducting top-tier clinical research that helps Sponsors exceed timelines. Furthermore, by strictly adhering to protocols and ICH-GCP guidelines, we ensure efficient and reliable outcomes. In fact, our track record speaks for itself, with patient recruitment and retention rates consistently in the upper 90th percentile. Above all, we uphold the highest standards in medical research, guided by our core principle: “Achieving Excellence Through Integrity and Quality.” At Advanced Pharma, we are passionate about conducting top-tier clinical research that helps Sponsors exceed timelines. Furthermore, by strictly adhering to protocols and ICH-GCP guidelines, we ensure efficient and reliable outcomes. In fact, our track record speaks for itself, with patient recruitment and retention rates consistently in the upper 90th percentile.