Research Center Profile:
Advanced Pharma CR
Hepatology (Liver, Pancreatic, Gall Bladder)
Nutrition and Weight Loss
"First in Man to Market"
Advanced Pharma CR (APCR) is a dedicated Phase I Clinical Research Facility. We are located within the City of Miami’s Health District, the second largest in the nation, in the architecturally “green” University of Miami Life Science and Technology Park. Our location bolsters our relationships with many specialists and subspecialists and serves as a magnet for attracting a high volume of volunteers, while providing a state-of-the-art facility for pharmaceutical, biotech, and medical device industries.
APCR provides pharmaceutical, biotech, and medical device companies with a state-of-the-art, 25,000 square feet facility that houses 150 beds, which includes two (16 bed and 24 bed) Intensive Procedure Units (IPUs).
APCR’s principals have participated in Phase I clinical trials since 1992. Advanced Pharma’s Executive Medical Director Dr. Gilbert R. Weiner, DO, AOBFP, CPI is board certified in Family Practice and has been practicing medicine since 1967. As a Certified Physician Investigator, Dr. Weiner has participated in over 500 Phase I clinical trials. Dr. Weiner and the rest of our team have 50-plus years of combined research experience in over 1,000 Phase I trials. Our multi-specialty physician investigators enable APCR to engage in multiple aspects of Phase I pharmaceutical, biotech, and medical device trials.
Our historical volunteer data confirms that we have outstanding recruitment, enrollment, and retention statistics. We retain a robust database of over 10,000 volunteers. APCR exceeds industry standards for enrollment requirements and trial completion percentages.
Phase I Trial Experience: Healthy Volunteers
Absorption Distribution Metabolism & Excretion (ADME)
Food Effect (Fed/Fasted)
Maximum Tolerated Dose
Phase I Trial Experience: Special Populations
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)
Classification as Mild, Moderate, and Severe, including Dialysis
Type II Diabetes
Route Administration Experience
Injection: IM and Sub-Q
In addition to the Phase I experience listed above, we serve ALL Specialties and ALL Indications.
Late Phase Development
Phases II-IV Clinical Research Experience
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
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:
Johnson & Johnson
Bristol Myers Squibb
Schering Plough Research Institute
Our current operations include a 25 bed dedicated Phase I Unit. Expansion to 25,000 square feet is underway. Upon completion of the build-out in November 2012, we will house 150 beds, which will include two (16 bed and 24 bed) Intensive Procedure Units (IPUs).
Clinical Trial Services
Advanced Pharma includes the following departments, each with its own dedicated staff of skilled, appropriately trained and certified professionals.
Contracts and Budgeting
Recruitment & Retention
Training (Study/Protocol Specific)
Source Document Creation & Implementation
Quality Assurance/Quality Control
Phase I Business Development
Phase II-IV Business Development
Marketing & Advertising
Our facility has the following areas and features:
Secured, Dedicated Pharmacy
Secured, Dedicated Laboratory
Secured, Dedicated Record Room
Physical Examination Areas
Dosing and Procedure Room
Recliner Equipped Dosing Area
Observation Sleep Areas
Secured Server Room
Fully Generator Equipped for 24-7, 365 days of uptime
Dedicated Reception Areas
Dedicated Monitoring Room with Phone and Internet Access
Security Cameras throughout Facility
Building Alarm System
Synchronized Study Clocks
President & CEO
Samantha Amaba began participating in research in 1992, when she took part in Cardiology Device Research at a large teaching hospital in Memphis, TN. After acquiring a wealth of research experience, Samantha relocated to South Florida where she became involved in Pharmaceutical Research, in particular managing Phase I-IV Clinical Trials. She has substantial management experience in Special Populations as well. Samantha has demonstrated exceptional ability to direct multiple million-dollar trials with complete satisfaction from clients.
Through the years, Samantha has maintained an excellent relationship and reputation within the pharmaceutical industry. Her passion for Clinical Research has proven to be the avenue to her success!
Ivette Lopez, CCRC
Vice President & COO
Key Members of APCR
Gilbert Weiner, DO, AOBFP, CPI
Medical Director - Principal Investigator
Terrye Thomas, RPh
Associate Director, Pharmacy
Advanced Pharma CR uses a local/central IRB, Independent IRB, and we are also willing to work with an IRB of your choosing.
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.