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Austin Clinical Pharmacology Unit


In operation since 1986, PPD’s award-winning clinic in Austin, Texas is one of the largest of its kind in the world and is designed to execute the full spectrum of PPD’s early development services. Highlights of the unit include:

  • 185 beds, specifically designed for early phase and clinical pharmacology trials, with a dedicated outpatient facility
  • Capacity to conduct multiple, complex and procedurally intensive studies simultaneously in healthy volunteers
  • A wide variety of equipment for storing, handling, administering and monitoring the effects of new drugs
  • The ability to conduct long-term confinement studies
  • Access to a diverse surrounding population that exceeds two million people, including a significant number of students at local colleges and universities, resulting in rapid study enrollment

The clinic’s expert team has wide reaching experience conducting the following types of studies:

  • First-in-human (SAD/MAD)
  • Bioavailability/bioequivalence
  • Drug-drug interactions
  • Food effect
  • Thorough QTc

Prequalified volunteers receive a detailed explanation of the study requirements and known potential risks. Volunteers' questions are answered, and they are asked to sign the IRB-approved, study-specific informed consent form. Study volunteers are qualified for trial participation by the principal investigator based on a review of the subject's medical history and the results of a thorough physical exam and required diagnostic tests.

Special Volunteer Populations

PPD's clinical research units are able to support special volunteer population study requirements including elderly, post-menopausal, poor and extensive metabolizers, obese and smokers.

PPD’s early development services team supports site identification, selection and management for patient population studies including but not limited to renal, hepatic, diabetic, neuroscience and abuse liability.

Tour the Austin Clinic

Since 1986, PPD has been conducting first-in-human trials, definitive cardiac safety and QTC studies, and complex procedure intensive trials. Our state-of-the-art 128,000-square-foot facility in Austin focuses on increased efficiencies and best practices. Take a walk through the clinic in our virtual tour.

 

Special Equipment at the Austin Clinic

  • Cardiac telemetry (Mortara Surveyor™ Telemetry Central System)
  • Dedicated space for clients to monitor trials
  • Meal planning oversight by a registered dietician
  • CLIA-and CAP-accredited onsite clinical laboratory
  • Intensive monitoring equipment for first-in-human and safety trials
  • USP <795> and <797> compliant, limited access, environmentally controlled onsite pharmacy for investigational drug storage and preparation of all clinical doses
  • Secure, confidential drug storage and handling through high security, limited access onsite pharmacy department with compounding capabilities
  • Registered pharmacists to manage drug receipt, accountability and disposition
  • Equipment, procedures, training and expertise for sterile and non-sterile compounding of early formulation IP
  • USP <800> compliant negative pressure suite with biological safety cabinet for aseptic preparation of parenteral and hazardous doses
  • DEA registration for receipt and management of controlled drugs
  • Refrigerated centrifuges
  • -20°C and -70°C subzero freezers
  • Backup generator in event of a power outage

Contact Austin Clinical Pharmacology Unit

7551 Metro Center Drive, Suite 200
Austin, TX 78744
+512 447 2985

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