Principal Investigators
Phase I Clinical Trials
Clinical Areas
- 4 exam rooms
- 8 treatment chairs
- 1 treatment chair for blood draws and procedures, as needed
Investigational Drug Section (IDS)
Pharmacy Equipment
All equipment is annually inspected and calibrated and includes the following:
- 2 biological safety cabinets
- Negative pressure clean room
- Positive pressure anteroom
- Secure medication storage room with continuous temperature monitoring for both cold storage and room temperature storage
- 1 pharmaceutical grade -20°C freezer
- 1 pharmaceutical grade -80°C freezer
- 1 pharmaceutical grade refrigerator 2 – 8°C
- Room temperature storage shelving (20 – 25°C)
Pharmacokinetics
Biopsy Specimens
PK department staff are present at the time of biopsy and process specimens according to protocol requirements.
Laboratory Equipment
All equipment is annually inspected and calibrated and includes the following:
- Refrigerated / room temperature centrifuges (3000g(rcf )/4400 rpm)
- -80°C freezer with continuous temperature monitoring
- -20°C freezer with continuous temperature monitoring
- Pharmaceutical grade refrigerator 2 – 8°C
- Room temperature storage shelving
Regulatory Affairs & Data Management
Data Entry Capabilities
- Every study has a dedicated START Clinical Research Assistant (CRA)
- START has experience with a wide variety of electronic data capture systems (i.e., Medidata RAVE, InForm, Tempo, DataTrak, etc.).
- START ensures clean, accurate, and timely data entry and query resolution.
- 10 business days for data entry
- 5 business days for query resolution
On-Site Monitoring Area
- 4 monitoring workstations with high-speed Internet and desktop computers for accessing the EMR
- Wi-Fi is available for EDC access
- Basic office supplies, copier, and telephone are available
- On-site monitoring hours are Monday – Friday (hours TBD)
Remote Monitoring Services
- START’s remote monitoring service allows the monitor to have access to our EMR and e-ISF (Veeva) systems without having to be on-site.
- Remote monitoring hours are Monday – Friday (hours TBD)
Scheduling Monitoring Visits
- The assigned START CRA is the main point of contact for the scheduling of all on-site and/or remote monitoring visits (i.e., initial, interim, and close-out visits, etc.).
- Monitor visits must be scheduled at least 30 days in advance. Requests for co-monitors must be reviewed by the study team and approved by the Principal Investigator.
Hybrid Monitoring (Onsite and Remote)
- Monitors will be required to conduct on-site and remote visits during the following times: First monitoring visit and once per quarter may be conducted ON-SITE. All other visits will be conducted REMOTELY.
