Phase I Clinic: Capabilities

This 128,000-square-foot, 300-bed facility in Austin, Texas is one of the largest Phase I clinics in the world. It is fully equipped with special equipment reflecting our commitment to optimal support. The clinic, which conducts approximately 130 studies per year, has sufficient capacity to carry out multiple studies simultaneously using numerous study designs and housing qualified volunteers in the clinical pharmacology unit. Research-experienced, board-certified physicians serve as sub-investigators, and facilities and procedures ensure security and confidential drug storage and handling.

For an idea of the capabilities of the PPD Phase I clinic, view our video.

An independent review board (IRB) meets weekly, assuring timely review of protocols. Regulatory approval documents are usually available within 48 hours following the review.

Special Equipment at the Austin Clinic

Cardiac telemetry
CLIA and CAP-accredited clinical laboratory
Intensive monitoring equipment for first-in-man and radio-labeled studies
Locked controlled-temperature facilities for drug storage

Room temperature storage
Cold storage

Refrigerated centrifuges
-20°C and -70°C quick recovery freezers
Laminar flow hood for preparation of sterile doses
Emergency power generation in case of a power outage

Physician Investigators

Research-experienced, Board-Certified physicians are available to serve as sub-investigators for Phase I trials. Areas of therapeutic expertise include, but are not limited to:

Cardiology
Dentistry
Dermatology
Endocrinology
Gastroenterology
Gynecology
Nephrology
Neurology
Oral surgery
Psychiatry
Rheumatology

Security and confidential drug storage and handling

A registered pharmacist handles drug receipt, accountability and disposition. Track shelving and controlled-entry access ensures confidential drug storage and handling. Closed circuit television assists staff in providing around-the-clock security to ensure the safety of subjects and compliance with study protocols.

Volunteer accommodations for residential studies

Qualified volunteers are given color-coded t-shirts and wristband identification assigned to a specific study, and escorted to the clinical pharmacology unit (CPU) where they remain housed for the duration of the study. In addition to the regular wards, the CPU has a ward that is customized to meet the needs of volunteers over 65. Entertainment and recreation facilities are available in the CPU for the use of volunteers during their stay.