Site equipment and capabilities
Site Equipment:
General
- 12-Lead ECG
- Incubator
- Scales
- Centrifuge
- Refrigerated Centrifuge
- Sphygmomanometer
- Thermometers
- Spirometer
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 Equipment:
Refrigeration-Related Equipment
- 2-8°C Refrigerator
- -20°C Freezer
- -70°C Freezer
- -80°C Freezer Dry Ice
- Calibrated Thawing Device for Infusion Bags or Cryo-vials
Site Facilities:
Type of Facility
Private Clinic/Practice
Ambulatory Outpatient Clinic
Site Affiliations
- 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
- 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 (off-site)
- Perform Flow Cytometry