Advanced Pharma - Miami

• 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 Experience: Healthy

Volunteers

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
• Food Effect

Phase I Experience: Special

Population

• 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

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

Endocrinology

• Type I Diabetes
• Type II Diabetes
• Adrenal Disorders
• Metabolic Syndrome
• Thyroid Disease
• Hypothyroidism
• Hypoglycemia

Cardiovascular

Women's Health

Women’s Health

• Perimenopausal
• Postmenopausal
• STD’s
• PCOS
• Endometriosis
• Uterine Fibroids
• Menstrual Irregularities
• Bacterial Vaginosis
• Ovarian Cysts
• Postpartum Depression
• Premenstrual Syndrome
• Urinary Incontinence
• Yeast Infections

Autoimmune Diseases

• Rheumatoid Arthritis
• Lupus
• Sjogren’s Syndrome
• Psoriasis
• Alopecia Areata

Dermatology

• Atopic Dermatitis
• Alopecia
• Pruritus
• Plaque Psoriasis
• Eczema
• Warts
• Herpes Labialis
• Acne
• Rosacea

Respiratory

• Asthma
• COPD
• Pneumonia
• Influenza

Respiratory

Psychiatric

Psychiatric

• Schizophrenia
• Clinical depression
• Anxiety disorder
• ADHD
• Dementia
• PTSD

Building Features

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

Building Features

Security

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

Security/

IT

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

Patient Amenities

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

Pharmacy

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

Laboratory

Secured Temperature Controlled Rooms

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

Secured Temperature Controlled Rooms

Now offering Onsite FibroScan® Services for NASH, NAFLD and Hepatic Impairment Studies

What is FibroScan?

It is a type of ultrasound that can measure the degree of inflammation in your liver. Specifically, fibrosis (scarring) and steatosis (fatty change).

Fatty change is when fat builds up in your liver cells.

What are the Benefits?

Having a FibroScan® will help a doctor understand how much scarring or fat buildup is in their patient liver and learn more about their risk of liver disease. The results are immediate.

Recruitment & Retention

• Multilingual Call Center: Monday – Friday 8:00am – 5:00pm.
• Facility is located in the heart of Miami, with the draw capability over 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 over 50 specialty doctors across all indications, provides availability to Special Populations – Hepatic Impairment (including NASH, NAFLD), Renal Impairment, Diabetes, Women’s Health, Dermatology, etc.

Customers we have worked with over the past 10 years

Visit Our Website

https://www.advancedpharmacr.com/

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