Currently Enrolling Trials

• Hepatic Impairment/Liver Disease (Severe)
• Impaired Renal Function/Kidney Disease Single Dose Study
• Low Testosterone Replacement Therapy
• Non-Alcoholic Fatty Liver Disease
• Renal Impairment Kidney Disease Study
• Sickle Cell Disease Study
• Sickle Cell Food Study
• Sickle Cell Single/Multiple Dose Study

Overview

Advanced Pharma - Miami is a dedicated phase 1­ clinical research facility participating in clinical trials since 1992 with more than 50 years of combined experience. Having our multispecialty physician investigators enables us to engage in many aspects of the pharmaceutical development, bio­tech and medical device trials.

Our team of experts is dedicated to sustaining safe, ethical and high-quality medical research so sponsors can exceed their deadlines and patients can benefit from the development of new treatments and therapies. We pride ourselves in bringing efficiency, innovation and value to the clinical research process. Our strict adherence to protocol and ICH GCP guidelines, along with our uniform delivery of quality data, guarantees the most efficient and timely outcome in all of the trials that we conduct. 

Our historical patient data confirms that we have outstanding recruitment and retention percentages in the upper 90s. We hold ourselves accountable to our core principle, “Achieving Excellence Guided by Integrity and Quality” in all that we do, each and every day.

Research Experience

Phase I Capabilities:

Clinical Pharmacology

• First-in-Human (First in Man)
• SAD and MAD PK Studies
• Healthy vs. Patient population
• Drug Interactions
• Cardiac Safety (e.g. TQTc study)

Special Population

• Renal Impairment
• Hepatic Impairment
• Diabetes
• Age, gender, etc.

PK/PD

• Dose selection
• Efficacy vs. Safety

Biopharmaceutics

• Bioavailability/Bioequivalence (BA/BE)
• Food Effect

Phase I Experience: Healthy Volunteers

• 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

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
  • Lupus
  • Rheumatoid arthritis
  • Plaque Psoriasis

Treatment Areas

Departments

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

Customers

Our experienced research team has participated in clinical trials working directly with the following Sponsors/CRO's:

Staff Expertise

• Accounting
• Operations
• Human resources
• Administration
• Contracts and budgeting
• Regulatory affairs
• Facility operations
• Recruitment and retention
• Clinical operations
• Full-time, on-site, board-certified physician investigators, registered nurses and paramedics
• Clinical laboratory
• Data management
• Pharmacy
• Information technology
• Quality assurance/quality control
• Business development
• Marketing and advertising

Facility Description

Building Features 

• Cat-5 hurricane secured building
• Generator: services entire building
• EVAC helipad
• Pull-cord emergency devices
• Limited key-card access
• Visiplex synchronized study clocks
• Gated, secure patient parking
• Onsite water/fire proof record storage
• Monitoring rooms with phone and internet access
• Sponsor private entrance and waiting area
• Full time maintenance

Security/IT 

• On-site 24 hour security
• State-of-the-art security system
• Redundant backup internet service
• Security cameras throughout facility
• Server secured with encrypted fire wall with 24 hour IT monitoring partner  
• HIPAA Compliant/Certified

Patient Amenities 

• 100+ beds 
• Three 6-8 bed intensive procedural units
• Individual patient bedrooms
• Private entrance and waiting area
• Recreation room
• Kitchen and dining areas
• Showers and locker rooms
• Handicap accessible restrooms
• Televisions throughout facility
• WiFi access

Pharmacy

• Hazardous chemical storage
• Controlled drug safe 
• Secured, double-locked pharmacy
• Drug prep work bench
• 2 Laminar flow hoods
• Multiple -20° and -70° freezers
• Multiple 2-8° refrigerators

Clinical 

• Exam and procedure rooms
• 4 crash carts: defibrillators, AEDs, oxygen and suction.
• Telemetry and Holter Monitor capability
• Nursing stations to directly monitor each IPU
• Dosing rooms with recliners
• Screening and waiting rooms

Laboratory

• Refrigerated and non-refrigerated centrifuges
• Dedicated CLIA waived Lab
• Incubator
• Dedicated ice machine for lab samples
• Multiple -20° and -70° freezers
• Multiple 2-8° refrigerators

Secured Temperature Controlled Rooms

• Monitoring system for critical equipment
  • Lab storage
  • Pharmacy storage
  • Server room

Investigator Experience

Advanced Pharma - Miami’s principals have been working with pharmaceutical companies, advocacy groups and research organizations since 2002. In conjunction with these groups, we’ve participated in more than 1,000 clinical trials in a wide range of therapeutic areas.

• 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

Patient Demographics

• Multilingual call center: Monday-Friday, 8:00 a.m. to 5:00 p.m.
• Facility is located in the heart of Miami with the draw capability of more than 4 million participants.
• Outreach programs to local Miami-Dade County and Broward County.
• Social media presence on all platforms.
• Street team presence at community events and health fairs.
• Relationships with more than 50 specialty doctors across all indications provides availability to special populations – hepatic impairment (including NASH, NAFLD), renal impairment, diabetes, women’s health, dermatology, etc.

Other information

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

Advanced Pharma - Miami is committed to finding new and better ways to treat various diseases. Clinical trials are critical to the advancement of medicine and to improving patient health.

Volunteers participating in clinical trials:

• Receive care from a doctor or specialist at no charge, with no insurance needed;
• Contribute to the advancement of medicine and help improve the lives of others;
• Consider new treatment options that are not yet widely available;
• Have a better understanding of their medical condition;
• Play an active role in their healthcare; and
• Receive financial compensation for their time and travel.