- Director, Clinical Research Unit
- Director, Office of Human Research
1020 Samson Street
1100 Thompson Building
Philadelphia, PA 19106
Mission, Goals, Capabilities
The Clinical Research Unit has 6,500 sq feet and 14 inpatient research beds within TJUH. The staff is experienced with the design, conduct and analysis of Phase 1 clinical research studies.
The Clinical Research Unit of Thomas Jefferson University is suited perfectly for conducting sponsored clinical trials. We are particularly experienced in conducting Phase I and Phase II clinical trials, and have also participated in Phase III clinical trials. This modern CRU has over 35 years experience in conducting human clinical trials in support of drug development by pharmaceutical or biotechnology partners as well as by investigators in academia.
- Monitor cardiovascular function.
- Control dietary intake and composition.
- Perform infusions.
- Measure metabolic balance.
- Perform remote data entry.
- Perform studies that require radiolabeled drugs.
- Perform studies that include a component of exercise physiology.
- Perform studies of special populations (renal failure, hepatic insufficiency, geriatrics, etc.).
- Perform studies that require endoscopic procedures.
The various components of the Thomas Jefferson University Clinical Research Unit are housed in modern and purpose-designed areas of the University.
The Thomas Jefferson University Clinical Research Unit itself, dedicated to performing clinical studies, includes:
- A locked nursing unit of 6500 sq. ft.
- Sixteen subject beds in semiprivate rooms dedicated to clinical research.
- Dining facilities.
- Recreational facilities.
- Reception area.
- Waiting room for participants in clinical research studies.
- Separate rooms to conduct interviews and physical examinations.
- State-of-the-art 180-sq.-ft. laboratory for processing samples.
- Modern laboratory equipped to perform sophisticated analyses (RIA, HPLC, RT-PCR, etc.) of biological samples.
- Dedicated investigational pharmacy with facilities to prepare and store experimental therapeutics.
- Data processing center.
The Clinical Research Unit supports the following protocols, whether conducted with inpatients or outpatients:
- Safety and Tolerability
- Pharmacokinetics Produced by Either Single or Multiple Dose Schedules
- Pharmacokinetic-Pharmacodynamic Integration
- Dose Escalation/Dose Ranging (e.g., alteration in the dose of drug administered during the study)
- Food Interaction
- Metabolic Clearance
- Phase II and Phase III Multicenter Efficacy
The Clinical Research Unit is experienced in conducting studies in all major therapeutic categories, including:
- Infectious Disease