ABR's 72 bed Clinical Research Center (CRC) staff conducts Phase I- II and Phase II-IV outpatient studies involving investigational and marketed drugs and biologics.

Types of Phase I-II studies performed include:

Thorough and definitive QT (Digital ECG), relative and absolute bioavailability, Proof- of-Concept, First-In-Human-Trials (FIHT), bioequivalence, dose escalation safety/tolerability, fed-fasted, drug/drug and drug/alcohol interactions, pharmacokinetic (PK)-pharmacodynamic (PD), and special population studies.

ABR has a well established, successful track record of performing outpatient Phase II-IV clinical studies in selected patient populations, in a wide range of therapeutic areas.

Our Clinical Research Center is equipped to house research subjects for extended day and overnight evaluations for serial PK blood sampling and non-invasive or minimally invasive safety, efficacy and PD assessments. It is equipped with state-of-the art ECG telemetry monitoring equipment and digital ECG. Protocol specific testing equipment is often used including RigiScan, Platelet Aggregometer, Dinamap, Ambulatory Blood Pressure Monitor, Holter Monitor, and Endothelial function monitoring equipment, as examples.

Our secure drug storage area, accessible to study personnel only, is double locked, caged, alarmed and temperature controlled. The CRC is equipped with standard and cold centrifuges, and monitored refrigerators and -20 and -70° C freezers for proper specimen handling and storage.

The Center is complete with controlled access, internal security, and emergency electric back up capabilities. Occupying 3 floors, allowing for easy separation of concurrent studies or cohorts of the same study.

The Clinical Research Center is easily accessible from three major airports serving the area.

The CRC is staffed with study coordinators with medical, nursing and allied health degrees, physician Principal Investigators, and clinical pharmacists all of whom are experienced in conducting Phase I-IV clinical studies.

The clinic is located in Northern New Jersey convenient to an array of world class medical institutions and practitioners.

Located in Northern New Jersey, the facility has access to one of the nation’s most diverse ethnic, socio-economic, and special populations.

ABR provides quick turnaround on IRB reviews, study budgets, and contracts allowing for rapid study start-up. The CRC staff maintains strict adherence to the sponsor's study protocol, current Good Clinical Practice guidelines, and ABR's SOPs. The CRC staff is equally at home recording sponsor data either on paper case report forms or electronic data entry applications. Comfortable office space and a pleasant working environment are provided for study monitors. All study files are maintained on site and are readily available for review.

When partnered with full service CRO capabilities located in Princeton, NJ USA, ABR is capable of managing your study needs from pre-IND through approval. An integral part of any Phase I program is the PK or PK-PD data analysis. ABR has this expertise in-house and can offer non-compartmental, compartmental, and if needed, population PK analyses using industry recognized, state-of-the-art software. PD analysis can be either direct or indirect depending on the data available. As well as offering these services as part of any Phase I program, ABR can also provide stand alone PK or PK-PD data analyses.

Sponsor Contact:

Edward Bailey
Manager, Business Development
Advanced Biomedical Research, Inc.
117 Campus Drive, University Square
Princeton, NJ 08540 USA
tel: +1 609-818-1800 ext 145
fax: +1 609-818-0026
edward.bailey@abr-pharma.com
www.abr-pharma.com

For more information, please contact:

Dr. Wilfredo Garcia, MD
Director, Clinical Operations
Advanced Biomedical Research, Inc.
Clinical Research Center
241 Main Street
Hackensack, NJ 07601 USA
Phone: 201-678-0288
Fax: 201-678-0349
E-mail:

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the E-mail form below. A representative from the research center will then follow up with you.

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Last updated on February 19, 2008

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