Clinical Trial Resource Center

Therapeutic Areas

Cardiology/Vascular Diseases
Dermatology
Devices
Endocrinology
Family Medicine
Gastroenterology
Healthy Volunteers
Hepatology (Liver, Pancreatic, Gall Bladder)
Internal Medicine
Nephrology
Neurology
Nutrition and Weight Loss
Oncology
Pediatrics/Neonatology
Podiatry
Psychiatry/Psychology
Rheumatology
Urology
Vaccines

Center Overview

"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.

Clinical Research Experience

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 II Diabetes
• Elderly
• Hypertension
• Pre/Postmenopausal
• Obesity

Route Administration Experience

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
• 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:

Facility Description

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.

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
• Screening/Waiting Rooms
• Recreation Room
• Secured Server Room
• Fully Generator Equipped for 24-7, 365 days of uptime
• Dedicated Offices
• Dedicated Reception Areas
• Dedicated Monitoring Room with Phone and Internet Access
• Security Cameras throughout Facility
• Building Alarm System
• Synchronized Study Clocks
• Green-Friendly

Staff Expertise

APCR Principals

Samantha Amaba
President & CEO
samaba@advancedpharmacr.com

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
ilopez@advancedpharmacr.com

Key Members of APCR

Medical Staff

Gilbert Weiner, DO, AOBFP, CPI
Medical Director - Principal Investigator

Terrye Thomas, RPh
Associate Director, Pharmacy
tthomas@advancedpharmacr.com

Operational Staff

Sylvia Corrrea
Office Manager
scorrea@advancedpharmacr.com

Other Information

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

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.