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ABR Clinical Research Center

Our Clinical Research Center (CRC) staff conducts Phase I-II and Phase II-IV outpatient studies involving investigational and marketed drugs and biologics. ABR performs a wide range of Phase I-II studies including bioavailability, bioequivalence, first-in-man, dose escalation safety/tolerability, fed-fasted, drug-drug interactions, pharmacokinetic (PK)-pharmacodynamic (PD), and special population studies. ABR also has a well established, successful track record of performing outpatient Phase II-IV clinical studies in selected patient populations.

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. Our clinical research facility 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. The research facility is equipped with state-of-the art ECG telemetry monitoring equipment. All study protocols are supervised by the principal investigator who works closely with the study coordinators. Inpatient and outpatient study populations for clinical trials are carefully selected according to the sponsor's specifications. ABR maintains a large computerized database of healthy volunteers and patients which allows us to rapidly fulfill enrollment goals.

ABR provides quick turnaround on IRB reviews, study budgets, contracts allowing for rapid study start-up. The CRC staff pay close attention to adhering to the sponsor's study protocol, current Good Clinical Practice guidelines, and ABR's standard operating procedures. Such attention to detail maximizes research subject safety while also maintaining the accuracy and integrity of the clinical data. The CRC staff also has considerable experience recording sponsor data either on case report forms or in remote data entry applications.

ABR's comfortable office space provides a pleasant working environment for study monitors. All study files are maintained on site and are readily available for review. Our secure drug storage area, accessible to study personnel only, meets the necessary requirements for proper drug storage. The CRC is equipped with standard and cold centrifuges, and monitored refrigerators and -20 and -70ºC freezers for proper specimen handling and storage. The Clinical Research Center is easily accessible from three major airports serving the area.

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.