Services
ABR is a full service CRO offering an integrated package of customized services including clinical study design, project management, quality assurance auditing, medical safety monitoring, biostatistics and clinical data management, regulatory submissions, and scientific communications.
Our state of the art clinical research facilities in Hackensack, New Jersey provide a high quality study performance and is conveniently located in Northern New Jersey, within easy travelling distance of major airports and readily accessable by road and rail. Our careful pre-screening procedures for volunteers have resulted in a large computerized database that aids our ability to rapidly recruit male and female volunteers from diverse ethnic backgrounds.
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. Learn more...
Phase I-IV Study Monitoring
Our integrated project team approach to designing and managing clinical studies enables us to generate high quality clinical data in a consistent and rapid manner. Our clinical scientists apply the fundamentals of clinical research to assist sponsors in designing clinical development plans and studies which possess scientific rigor and fulfill regulatory requirements. Careful consideration is given to prospectively defining study objectives and selecting the most appropriate study design, research subjects, sample sizes, clinical endpoints, and statistical analyses.
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Data Management
Proactive involvement of our biostatisticians and clinical data coordinators helps to assure the efficient and accurate collection, analysis, and interpretation of clinical study data. Our biostatisticians are an integral part of the strategic planning process as they are involved in prospectively defining study objectives and selecting the most appropriate study design, research subjects, sample sizes, clinical endpoints, and statistical analyses. Our biostatisticians and clinical data coordinators assure that data are collected accurately and completely through their involvement in the study protocol and case report form design, review, and approval process.
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Statistical Analyses
Proactive involvement of our biostatisticians and clinical data coordinators helps to assure the efficient and accurate collection, analysis, and interpretation of clinical study data. Our biostatisticians are an integral part of the strategic planning process as they are involved in prospectively defining study objectives and selecting the most appropriate study design, research subjects, sample sizes, clinical endpoints, and statistical analyses. Our biostatisticians and clinical data coordinators assure that data are collected accurately and completely through their involvement in the study protocol and case report form design, review, and approval process.
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Medical Writing
A key element of the clinical development process is effectively "telling the story", whether within the context of a clinical study report, a clinical development plan, an international registration dossier, or an original research article or state-of-the-art review. Our medical writing team is comprised of experienced clinical scientists/medical writers who are skilled at data interpretation and the clear and effective communication of scientific data to the target audience. Our clients benefit from the scientific background of our medical writers who possess extensive knowledge of the pathophysiology and treatment of diseases as well as an ability to rapidly assimilate new scientific information for novel technologies.
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