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Executive Summary
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Strategic planning and setting critical mile stones of clinical study, study product development, presentation of the product for patient specific studies, and patient compliance has become an important aspect in the pharmaceutical and biotechnology product development. Pharmaceutical and biotechnology product manufacturers of today are facing immense tasks in bringing their products to market in time. Because of the complexicity of regulatory requirements, increased competition, cost-effectiveness, and more of all the important one timeliness, outsourcing the majority of critical aspects of the clinical trial management program proves more efficient. Further, there is an absolute need for fully validated information technology systems to facilitate the clinical study sponsors in monitoring several studies, keeping up time lines, data acquisition, compilation, and reporting.
EMINENT Services Corporation (EMINENT) was founded in 1997 as a Maryland Corporation, to assist the emerging pharmaceutical and biotechnology companies as well as institutional and clinical research organizations (CRO) in meeting clinical drug regulatory issues while planning Phase I, II, and III clinical studies, as well as providing a practical solution in addressing comprehensive clinical management services (product development, patient specific presentation, randomization, distribution, drug product inventory monitoring at the clinical site level, patient compliance monitoring, return drug accountability, biological specimen storage, and disposition services to clinical sites) and information technology services (systems design, development, and validation) in a timely as well as a cost-effective manner. EMINENT is committed in providing quality services and information systems while reducing the time involved in the product development, packaging and labeling, distributing the ultimate clinical site or patient, which is a very important aspect in the whole conduct of the clinical study.
A well planned clinical study is the key to the success of any emerging pharmaceutical or biotechnology company. EMINENT is the ideal partner to assist the pharmaceutical and biotechnology industry in their clinical studies with regulatory issues, cGMP issues, study product development, and information management and technology.
EMINENT is committed to provide quality contract services to the pharmaceutical and biotechnology industry, academic/health care institutions, and federal/state government-funded programs in the fields of drug regulatory affairs, study product development, clinical trial materials management, cGMP/ISO 9001/QA/QC compliance, Investigational Drug Management, and Information Technology Services (systems design, development and validation).
EMINENT facilities include an FDA registered drug establishment consisting of Investigational Drug Repository, Packaging and Labeling facility, direct to patient drug distribution facility, pharmaceutical research laboratory; registered with Maryland State Board of Pharmacy as pharmaceutical distributor, mail order pharmacy, and manufacturer, biological specimen repository.
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