Facility Phase I – IV

Phase I

Phase I and Pharmacokinetic Capabilities

  • 2700 sq. ft.
  • 6 beds (+4 infusion chairs) with 2 bathrooms (1 with shower)
  • One common ward area
  • Lounge/kitchen area
  • Long, open hallways
  • Safe/enclosed parking lot
  • Alarm secured when not in use (sound-based)
  • Fire alarm alerts directly to fire department for 1st response
  • Dedicated work space for monitors
  • T1 internet access

Phase I Equipment

Cardiac Life Support

  • Welch Allyn AED 20
  • Welch Allyn ECG
  • Welch Allyn ABPM
  • Welch Allyn Propaq LT – Continuous Pulsox and Continuous ECG monitoring
  • Emergency Medications/Banyan Stat Kit
  • Schuco-Vac model S130p
  • Oxygen Drug Mixing and Delivery
  • NuAire Laminar Flow Hood
  • Hospira Lifecare 5000 IV pumps Glucose
  • YSI Machines Obesity/Weight Loss
  • Tanita Body Composition Analyzer Osteoporosis
  • Hologic 4500W DXA Lab
  • -20 and -70 freezers
  • 2 degree C to 8 degree C refrigerators
  • On-site specimen processing lab
  • Refrigerated centrifuge
  • Table top centrifuge Energy Backup
  • 5 instant generators
  • 1 main generator

Phase I Expertise in Glucose Clamp

  • Described by DeFronzo, Tobin, and Andres in 1979 to quantify insulin resistance and secretion
  • Excel template developed by Dr. Christiansen, using DeFronzo equations, to assist with clamp studies
  • Personally performed over 60 clamps, (30 individuals before and after intervention) from 120 to 240 minutes (Diabetes Care, 2000 23(7), p 1000-1005)
    – Stable glucose levels within 60 minutes
    – Program capable of different insulin elevations, depending upon the study
    – Most studies were isoglycemic, program allows for this to be adjusted also

 

Phase I Experience

Therapeutic area experience

  • Alzheimer’s Disease
  • Device Studies
  • Diabetes – Type 1
  • Diabetes – Type 2
  • Diabetic Neuropathy
  • Hypercholesterolemia/Dyslipidemia
  • Osteoporosis/Osteopenia (male and female)
  • Renal Insufficiency

Phase I type of study experience

  • PK/PD
  • Dose Finding
  • Proof-of-Concept
  • Bioequivalence
  • Pivotal Safety and Efficacy
  • Nerve Conduction
  • Endpoint/Outcome

Phase I pharmacologic classes experience

  • Bisphosphonates
  • Cathepsin K
  • Continuous Glucose Monitoring
  • DPPIV
  • Glucagon-Receptor Antagonists
  • Glucokinase Activators
  • Incretins (GLP1)
  • Inhaled Insulin
  • Monoclonal Antibodies
  • Rank-L
  • VEGF
  • Stearyl CoA-Dehydrogenase Inhibitors

Phase II-IV

Clinic Equipment

  • On-site specimen processing lab
  • Refrigerated centrifuge
  • -20º & -70º freezers
  • Temperature logs
  • Electrocardiogram
  • Hologic 4500W Dexa Machine
  • Hologic Sahara Clinical Bone Sonometer
  • Pulmonary function testing
  • Cholestech LDx lipid analyzers
  • HgbA1c analyzer
  • Sensory neuropathy testing equipment
  • .5 mile to hospital with ultrasound, mammography, x-ray, and nuclear medicine

Certifications/Outreach
Programs/Audits

  • IATA certified staff for the shipment of hazardous materials
  • CLIA certified laboratory
  • Local health fairs (view), screenings and education seminars
  • FDA Audit 2001 – no 483s (view)
  • Multiple sponsor audits for top enrolling site – no concerns
Population

  • 11,000+ qualified and highly characterized searchable subject database
  • 5.4 million people in suburbs of San Francisco, CA

Space

  • 12,000 sq. ft. clinical facility
  • 4 exam rooms
  • PFT room
  • DXA room
  • Dedicated monitor space with multiple Internet acccess lines
  • Locked drug closets
  • Conference room
  • Kitchen
  • Archive room

Staff

  • 6 clinical investigators
  • 9 clinical coordinators
  • Lab technician
  • 2 regulatory personnel
  • Marketing/community outreach
  • 4 recruitment specialists
  • Information Technology Specialist
  • Dietitian
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