Advanced Pharma - Miami

Center Information

Samantha Amaba
President & CEO
Advanced Pharma - Miami
2950 NW 83rd Street
Miami, FL 33147
305-220-2727
305-220-2730
samaba@advancedpharmacr.com
www.advancedpharmacr.com

Currently Enrolling Trials

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Therapeutic Areas

Cardiology/Vascular Diseases
Dental and Oral Health
Dermatology
Endocrinology
Gastroenterology
Genetic Disease
Hematology
Hepatology (Liver, Pancreatic, Gall Bladder)
Immunology
Infections and Infectious Diseases
Musculoskeletal
Nephrology
Neurology
Nutrition and Weight Loss
Obstetrics/Gynecology (Women’s Health)
Oncology
Ophthalmology
Orthopedics/Orthopedic Surgery
Otolaryngology (Ear, Nose, Throat)
Pediatrics/Neonatology
Podiatry
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Rheumatology
Urology
Vaccines

Overview

Advanced Pharma - Miami is a dedicated Phase I-IV Clinical Research Facility. Our principals have participated in clinical trials since 1992 and our team has 50-plus years of combined research experience. Our multi-specialty Physician Investigators enable us to engage in many aspects of Phase I-IV Pharmaceutical, Bio-tech and Medical Device Trials.

Our team of experts is dedicated to sustaining safe, ethical, high-quality medical research so sponsors can exceed their deadline and patients can benefit from the development of new treatments and therapies. We pride ourselves on bringing efficiency, innovation and value to the clinical research process. Our strict adherence to protocol and GCP standards, along with our uniform delivery of quality data guarantees the most efficient and timely outcome in all trials. Our historical patient data confirms that we have outstanding recruitment and retention percentages in the upper 90’s.

We hold ourselves to our core principle, “Achieving Excellence Guided by Integrity and Quality”, in all that we do, each and every day.

As a turnkey facility, we equip our sponsors with more than just a venue. Advanced Pharma - Miami includes the following departments, each with its own dedicated staff of skilled and appropriately trained and certified professionals.

  • Accounting
  • Operations
  • Human Resources
  • Administration Team
  • Facility Engineer
  • Contracts and Budgeting
  • Regulatory Affairs
  • Recruitment & Retention
  • Clinical Team
  • Clinical Operations
  • Full-time On-site Board Certified Physician Investigators, Registered Nurses and Paramedics
  • Facility Operations
  • Clinical Laboratory
  • Data Management
  • Pharmacy
  • Information Technology
  • Quality Assurance / Quality Control
  • Phase I Business Development
  • Phase II-¬IV Business Development
  • Marketing & Advertising

Experience

Early Phase Capabilities:

  • Clinical Pharmacology
    • First-in-Human
    • SAD and MAD PK Studies
    • Healthy v. Patient population
    • ADME (Mass Balance)
    • Specific Populations
      • Renal Impairment
      • Hepatic Impairment
      • Age, gender, etc.
    • Drug Interactions
    • Cardiac Safety (e.g. TQTc study)
  • PK/PD
    • Dose selection
    • Efficacy v. Safety
  • Biopharmaceutics
    • Bioavailability/Bioequivalence (BA/BE)
    • Food Effect

Phase I Trial Experience: Healthy Volunteers

  • Bioavailability/Bioequivalence (BA/BE)
  • Ascending Dose
  • Absorption Distribution Metabolism & Excretion (ADME)
  • 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

Phase I Trial Experience: Special Populations

  • 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
  • Psychiatric
    • Schizophrenia

Late Phase Drug Development

  • Gastroenterology: GERD, Crohn’s Disease, Ulcerative Colitis, Irritable Bowel Syndrome with Diarrhea/Constipation, Gastritis; Hepatic Impairment: Hepatitis A, B and C, Hepatic Cirrhosis
  • Nephrology: Renal Insufficiency (mild, moderate, severe, including Dialysis), Chronic Kidney Disease
  • Cardiology: Hypertension, Acute Coronary Syndrome, Chronic Heart Failure, Atrial Fibrillation, Hyperlipidemia
  • Dermatology: Psoriasis, Eczema, Dermatitis, Discoid Lupus Erythematosus
  • Endocrinology: Diabetes (Type I & Type II), Hypo- & Hyperthyroidism, Cushing’s Syndrome, Acromegaly
  • Internal Medicine: Geriatric, Obesity, Weight Loss & Dietary Assistance, Smoking Cessation
  • Medical Device: Orthotics for Diabetic Foot Ulcers, Diabetic Neuropathy, Plantar Fasciitis
  • Neurology: Epilepsy
  • Oncology/Hematology: Iron Deficiency Anemia, Lung Cancer, Breast Cancer, Bone Cancers, Uterine Cancer
  • Pain Management: Opioid Induced Constipation (OIC), Low Back Pain, Intractable Pain
  • Podiatry: Plantar Fasciitis, Bunions, Ingrown Nails, Nail Fungus
  • Pulmonology: Emphysema, COPD, Asthma
  • Psychiatry: Depression, MDD, Schizophrenia, Anxiety, Cognitive Disorders
  • Rheumatology: Arthritis, Lupus, Systemic Lupus Erythematosus
  • Urology: Urinary Tract Infection, Acute Pyelonephritis
  • Vaccines: Measles, Mumps, and Rubella (MMR), Flu, Human Papillomavirus
  • Women’s Health: Uterine Fibroid, Hormone Replacement Therapy (HRT), Osteoporosis, Postmenopausal

Throughout the years, our experienced research team has participated in clinical trials working directly with the following Sponsors/CRO's:

  • AMAG Pharmaceuticals
  • AbbVie
  • Abbott
  • Achaogen, Inc
  • Allergan
  • Amgen
  • Applied Therapeutics
  • Arriane Corp.
  • Astra Zeneca
  • Aventis
  • Ayerst Laboratories
  • BMS
  • Berlex Laboratories
  • BioCryst Pharmaceuticals Inc
  • BioDelivery Sciences International, Inc. (BDSI)
  • BioSante Pharmaceuticals
  • Boehringer Ingelheim Pharmaceuticals
  • Bristol-Myers Squibb
  • Celgene
  • Cempra
  • Cetero
  • Chelsea Therapuetics, Inc.
  • Concert
  • ContraVir Pharmaceuticals
  • Cubist Pharmaceuticals
  • Derma Sciences
  • Diamyd
  • Dow Pharmaceuticals
  • Eisai
  • Eli Lilly and Company
  • Ferring Pharmaceuticals Inc.
  • Forest Laboratories
  • Forest Research Institute, Inc.
  • GRIFOLS Therapeuticals Inc.
  • GSK
  • GW Pharma LTD
  • Galderma
  • Genentech
  • Genzyme
  • Gilead Sciences, Inc.
  • GlaxoSmithKline
  • HanAll BioPharma Co., Ltd.
  • Hospira
  • ICI Pharmaceuticals
  • ISIS Pharmaceuticals
  • Innocoll Pharmaceuticals
  • Integra LifeSciences Corporation
  • Ivax
  • Janssen
  • Johnson & Johnson
  • K-Force CRO
  • Kos Pharmaceuticals
  • MedImmune LTD
  • Merck
  • Merck Sharp & Dohme Corp., (a subsidiary of Merck & Co. Inc.)
  • Mylan
  • Novartis
  • Novartis Institutes for BioMedical Research
  • Novo-Nordisk
  • Novum
  • Nutrition Science Partners Limited
  • Organon Pharmaceuticals
  • Ortho McNeil
  • Otsuka Pharmaceutical
  • PPD
  • Perrigo Company
  • Pfizer
  • Pfizer Inc.
  • Pharmaceuticals
  • Pharmacosmos A/S, Rørvangsvej 30, DK-4300 Holbæk, Denmark
  • Purdue Pharma L.P.
  • Questcor Pharmaceuticals, Inc.
  • Regeneron Pharmaceuticals
  • Relypsa Inc
  • Rhythm Pharmaceuticals, Inc.
  • Roche
  • Roche Professional Diagnostics
  • Salix
  • Salix Pharmaceuticals
  • Sanofi
  • Sanofi-Pasteur
  • Sanuwave
  • Schering Plough Research Institute
  • Schwarz Biosciences, Inc.
  • Sepracor Inc.
  • Shinogi, Inc.
  • Shionogi
  • Solvay
  • Squibb
  • TAP Pharmaceuticals
  • Tesaro, Inc
  • Teva
  • Theracos, Inc.
  • Theravance
  • Tolerx
  • Toyoma
  • Ventrus Biosciences
  • Vertex Pharmaceuticals Inc
  • Watson
  • Wyeth
  • Yamanouchi

Facility

Our facility has the following areas and features:

  • 100+ beds
  • Three 6-8 bed intensive procedural units
  • Cat-5 hurricane secure building
  • Generator: services entire building
  • EVAC helipad
  • On-site security
  • State-of-the-art security system
  • Security cameras throughout facility
  • Pull-cord emergency devices
  • Limited key-card access
  • Visiplex synchronized study clocks
  • Gated, secure patient parking
  • Temperature monitoring for critical equipment
  • Secured, double-locked Pharmacy
  • Exam and procedure rooms
  • Dedicated CLIA waived Lab
  • Nursing stations to directly monitor each IPU
  • Dosing room with recliners
  • Monitoring rooms with phone and internet access
  • Screening and waiting rooms
  • Secured server with cloud back-up
  • WiFi access
  • 4 separate patient bedrooms
  • Patient kitchen and dining areas
  • Recreation room
  • Televisions throughout facility
  • Patient showers and locker rooms
  • Handicap accessible restrooms
  • 4 crash carts: defibrillators, AEDs, oxygen and suction
  • Multiple -20° and -70° freezers
  • Multiple 2-8° refrigerators
  • Refrigerated and non-refrigerated centrifuges
  • Incubator
  • Drug prep work bench
  • 2 Laminar flow hoods
  • Hazardous chemical storage
  • Blood pressure machines
  • ECG machines
  • Pulse oximetry

Other

Advanced Pharma - Miami uses a local/central IRB, Independent IRB, and we are also willing to work with an IRB of your choosing.

We serve ALL Specialties and ALL Indications.

Contact Center

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