Medpace Holdings Inc is a clinical contract research organization (CRO) that conducts clinical research for the development of drugs and medical devices. The company offers services for the clinical development process from Phase I to Phase IV in areas including oncology, metabolic disease, cardiology, antiviral and anti-infective (AVAI) and central nervous system (CNS). Its medical department consists of treatment leads who provide strategic direction for study design and planning, train operational staff, work with primary investigators, provide medical monitoring, and meet regulatory agencies. The company’s patient recruitment and retention department identifies patient motivators and potential barriers to joining and remaining in the clinical research study. Its clinical research associates provide site management services comprising in-house, onsite, and virtual monitoring. Medpace offers strategic, operational, and tactical regulatory guidance and creates scientifically grounded regulatory-compliant documentation at each stage of the drug and biologics development process for regulatory agencies. The company also provides data collected during clinical trials that aid regulatory submissions covering new drug applications (NDAs) or biologics license application for approval by the US food and drug administration (FDA). Its data science team develops detailed specifications for the collection, organization, validation, analysis, and quality control of clinical trial data; and biostatisticians help with trial design consulting, statistical methodology recommendations, programming expertise, and reporting accuracy.
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