PPD’s Phase I clinic conducts approximately 100 studies per year and has sufficient capacity to carry out multiple studies of varying design simultaneously. Research-experienced, board-certified physicians serve as principal investigators for Phase I studies. Secure and confidential drug storage is managed through a high security, limited access, onsite pharmacy department.
For an online tour of PPD’s Phase I clinic, view our video.
Local independent review boards (IRBs) meet weekly, assuring timely review of protocols. Approval documents are usually available within 72 hours following the review.
Special Equipment at the Austin Clinic
- Mortara Instrument Surveyor™cardiac telemetry system
- CLIA- and CAP-accredited onsite clinical laboratory
- Intensive monitoring equipment for first-in-man and safety trials
- USP 797 compliant, limited access, environmentally controlled onsite pharmacy for investigational drug storage
- Flow cytometry
- Refrigerated centrifuges
- -20°C and -70°C subzero freezers
- Laminar flow hoods for preparation of sterile doses
- Backup generator in event of a power outage
In addition to the principal investigator, research-experienced, board-certified specialty physicians serve as subinvestigators for Phase I trials. Subinvestigator specialty support includes, but is not limited to:
Confidential drug storage and handling
The dedicated Phase I pharmacy handles drug receipt, accountability and disposition. Track shelving and controlled-entry access ensure confidential drug storage and handling.
Volunteer accommodations for residential studies
Qualified volunteers are provided color-coded T-shirts and wristband identification assigned to a specific study and are escorted to the clinical pharmacology unit (CPU) where they remain housed for the duration of the study. Entertainment and recreation facilities are available in the CPU for the use of volunteers during their stay.