Clínica Optimus U – Clinical Research

Site Equipment and Capabilities

Site Equipment:

General

  • Laminar Flow Hood
  • Telemetry Access
  • 12-Lead ECG
  • Incubator
  • Scales
  • Centrifuge
  • Refrigerated Centrifuge
  • Sphygmomanometer
  • Thermometers
  • Spirometer

Site Equipment:

Refrigeration-Related Equipment

  • 2-8°C Refrigerator
  • -20°C Freezer
  • -70°C Freezer
  • -80°C Freezer Dry Ice
  • -120°C Monitored Vapor-Phase Liquid Nitrogen Dewer
  • -140°C Monitored Vapor-Phase Liquid
  • Nitrogen Dewer
  • Calibrated Thawing Device for Infusion Bags or Cryo-vials

Site Equipment:

Imaging-Related Equipment

  • X-Ray
  • CT
  • 1.5T MRI
  • 3T MRI
  • Bone Scan
  • MUGA
  • ECHO
  • Ultrasound
  • FDG-PET
  • Amyloid or tau PET tracers
  • Access to digital copies of all scans on & off site
  • DEX

Site Facilities:

Type of Facility

  • Private Clinic/Practice
  • Specialized Phase I Unit
  • Ambulatory Outpatient Clinic

Site Facilities:

Site Affiliations

  • Have satellite locations
  • Affiliated with a Government Agency
  • Affiliated with a Government Funded Health Service
  • Lab accreditation(s) include:
    CAP (College of American Pathology)
    CLIA (Clinical Laboratory Improvement Amendment)

Site Capabilities:

General

  • Use of Electronic Medical Records (EMR/EHR)
  • Accommodate a co-monitor
  • Accommodate an overnight patient stay, if 24-hour observation is needed
  • Accommodate study-related needs after hours on weekdays
  • Accommodate study-related needs on weekends
  • Accommodate blind maintenance for study receipt, preparation, and administration
  • Access to an unblinded pharmacist
  • Facilitate on-site monitoring visits
  • Back-up staff (in case primary staff are unavailable)
  • Unlimited WiFi
  • Access to ICU
  • Facilitate Hospitalization
  • Temperature monitoring available
  • Temperature records for refrigerators maintained and available
  • Temperature monitoring alarmed in the event that there is an excursion
  • Backup plan in the event of a power outage or equipment failure
  • SOP for IP storage and monitoring
  • Area secured with controlled access
  • Able to destroy IP on site/arranged study via sub-contractor
  • Able to work with radio labeled IP
  • Hold required licenses or registrations to receive, store, dispense and return
    controlled substances as required by local law
  • Capability to destroy IP onsite for controlled substances
  • Storage for controlled substances securely constructed with restricted access to
    prevent theft or diversion
  • Ability to conduct studies with schedule I substances (e.g. psilocybin, marijuana
    (cannabis), mathaqualone, etc.)]
  • Remote EMR access
  •  

Site Capabilities:

Lab

  • Access to a sleep lab
  • On-site laboratory
  • Off-site laboratory that’s typically used
  • Collect and process biomarker samples including, but not limited to, whole blood,
    serum, and saliva
  • Preparation of samples and arrangement for shipment to a specified study
    laboratory on the day of collection

Site Capabilities:

Drug or Procedure

  • Intravenous infusion of study drug
  • Intrathecal drug administration
  • Perform extensive PK blood draws (e.g., >2 hours and up to 8 hours)
  • Process blood samples for PK or PD analysis outside of normal working hours
    (Monday-Friday 8:00 AM-5:00 PM)
  • Perform Ophthalmology Exams (on-site or off-site)
  • Perform Flow Cytometry
  • Perform Platelet Aggregation Testing
  • Perform Leukapheresis
  • Perform Lymphodepletion
  • Perform Cell Infusion/Injection
  • Perform Right Heart Catheterization