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Clinical Research

Digestive Health & Liver Diseases

IBD Phase I Clinical Trial Unit

At the University of Miami Miller School of Medicine (UM), we have seen over 5000 IBD patients in the past 10 years and we actively recruit study participants from one of the largest health districts in South Florida and the second largest in the country.

The UM Health System operates or collaborates with multiple hospitals including:

  • University of Miami Hospital (UMH),
  • The Sylvester Comprehensive Care Center (SCCC), the only NCI-Designated Cancer Center in South Florida,
  • The Lennar Foundation Medical Center,
  • Jackson Memorial Hospital (JMH)

Unlike most large academic medical centers, our phase I unit enjoys a special fast track rapid contract / budget and regulatory submission process. Protocol and contract amendments are also processed via an accelerated route.

We are a premier study site for conducting phase I studies focused in special populations to advance the most innovative discoveries from bench-to-bedside. Our clinical research team has 5 IBD physician specialists, 2 dieticians, 5 study coordinators including contracts/grants specialist, regulatory/IRB specialist, quality assurance program, data manager, laboratory supervisor, and night coverage coordinators.

Our facility includes: 14 examination rooms, 32 bunks beds, 16 single bed, exclusive coordinator area, large consent area, patient lounge, double locked Investigation Product (IP) storage, locked file storage room, private monitor room, private parking lot, high speed internet, Wi-Fi for monitor use.

Phase I Unit Services

  • Consultation on study assessments based on mechanism of action of the drug
  • In-House laboratory for PK analyses
  • Metabolic kitchen for special diets
  • Endoscopic monitoring
  • Transcriptomic analysis: single cell LPMC or bulk RNAseq
  • Protein expression: Cytof, spectral flow
  • PBMC isolation laboratory
  • Biospecimen collection: Biopsies/serum/plasma/stools
  • Microbiome studies: Next-generation Sequencing using 16S, metagenomics, metabolomics, single-cell sequencing

In addition, we have the following medical equipment and environmental logistics to fulfill phase one trials:

  • EKG Machines
  • ABI Doppler Machine
  • Holter Monitors
  • Pulse Oximetry
  • Spirometry Equipment
  • ACLS Crash Cart
  • AEDs
  • Non-Frost-Free Refrigerators
  • Temperature Monitoring and Alarming System
  • Lab: Industrial Grade Fridge
  • -20° C Freezer
  • -80° C Freezer
  • -30 ° C Freezer
  • Refrigerator for Vaccine and Medication/ Drug
  • -30 ° C
  • -80 ° C
  • Fax Machines, Copiers, and Scanners
  • Automated and Manual Blood Pressure Monitors
  • Ambient and Refrigerated Centrifuge
  • Biannual Equipment Calibration
  • Dry Ice Availability

Please Contact Us

Academic office: 305-243-6404
Clinical office: 305-243-8644 (UMGI)
Fax: 305-243-6125