Services Provided 
 


The Clinical Trial Program (CTP) provides translational research and clinical trial services for development of diagnostic devices, vaccines and immune-therapeutics with a focus on the following clinical areas: infectious diseases, inflammation, oncology, and the aging immune system.

The CTP has the local capabilities to bring early-stage clinical trial opportunities to patients – from exploratory INDs to First in Human testing in healthy volunteers, and Proof of Concept studies in the target patient groups. 

Our translational research capabilities include:

  • Mechanism-of-action studies and immune pathway studies
  • Identifying predictive immune/gene profiles and biomarkers
  • Qualification and validating of genomic assays that focus on immune pathways predictive of the patient response or disease status
  • Integration of genomic feedback solutions in the clinical research program
  • SOP driven procurement, preparation and inventory of tissues/samples tailored to genomic and immune profiling assays (such as blood cells, bone marrow, lymph node, liver or gut biopsies, lymph-nodes, etc…).

We offer fully integrated translational and early phase development programs across a restricted number of therapeutic areas and drug classes, utilizing our network of hospitals, clinics and cancer centers in South Florida.

The VGTI Florida® Clinical Trial Program consortium of affiliated hospitals provides ready access to the resources needed for successful early phase trials, including in-house stays, highly trained physicians, experienced research nurses and technicians, advanced clinical technology, and access to healthy volunteers and discrete patient populations.  

Kristen Sweeney
Site Supervisor of Research
Martin Health System Center for Clinical Research

 


Click here to vist the website
 

Istvan Krisko, MD, Ph.D., FACP
Medical Director, Clinical Research
for Jupiter Medical Center

Specialties: Internal Medicine, Infectious Disease
and Travelers’ Medical Services
 


Click here to vist the website


 

We specialize in Proof of Concept studies, designed to demonstrate efficacy in the targeted patient populations, which integrates our expertise in genomics, and profiling of the immune system. Our focus is on well-designed early phase trials to provide the robust data needed to trigger best-informed early  “go/no-go” decisions.
 
Early Phase Trial Services Include:

  • Regulatory support for IND filing
  • Study start-up and patient recruitment
  • “Genomics” compliant informed consents
  • Therapeutic area expertise
  • Trial operations and site management
  • Disease modeling – immune profiling
  • Biomarkers development and analysis
  • Support from bio-informatics and immunology experts to interpret the results

All our clinical operations are tailored toward trials that incorporate genomic profiling and biomarkers.  

The selection of clinical trial design is carefully evaluated according to the strength of the preliminary evidence, and questions surrounding the genomic and/or bioassays, such as the marker assessment methods, the ease/feasibility of obtaining the specimens, the reliability and reproducibility of the assay, and additional costs involved with assessing the marker status of each patient. 

Trained biostatistical or bioinformatics collaborators are fully integrated in all aspects of the design of the trial:

  • Targeted (enrichment) designs
  • Biomarker stratified designs
  • Dealing with small sample size
  • Adaptive designs
  • Conditional stopping rules
  • Dose escalation designs
  • Prospective-retrospective designs /  archived tissue specimens.
     

Contact Information:
Patrick D Yeramian MD, PhD
VGTI Florida Clinical Trial Program Director

(772) 345-5669

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