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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.

Our project managers and clinical research associates (CRAs) offer a high level of quality and consistency in Phase I-IV clinical study monitoring and project management involving drugs, biologics, and medical devices. Project managers and CRAs are based in our New Jersey corporate headquarters and regionally throughout North America. The project manager serves as the primary liaison to the sponsor and is responsible for the overall study management. Project managers remain predominantly in-house, but co-monitor selectively to troubleshoot, keep "hands-on" with the project, and educate and direct CRAs as required. Monitoring services include 100% source document verification and comprehensive and timely site visit reports. Project managers and clinical research associates are thoroughly trained in current Good Clinical Practice study monitoring guidelines, regulations, and in disease pathophysiology and pharmacologic or therapeutic interventions relevant to the study population.