IT&E INTL GROUP Inc. (OTC:ITER)
Industry: Services
IT&E International Group, Inc., incorporated on April 22, 2002, is a life sciences organization focused on providing clients with services and solutions in the drug development process, clinical research and regulatory compliance. IT&E International Group offers a suite of clinical trial support services for Phase I through Phase IV clinical trials. The Company's services include patient and investigator recruitment, biostatistical analysis, data management, data entry and verification and regulatory affairs services. In addition, IT&E International Group assists its clients with case report form design, protocol development, data entry and verification, full tracking and audit trail documentation, adverse event reporting and the United States Food and Drug Administration (FDA) submissions. The Company also provides regulatory compliance services to pharmaceutical, biotech, healthcare and other life science companies by providing to them the expertise to evaluate, structure, implement and maintain effective quality programs and processes that ensure compliance with applicable FDA regulations. In November 2005, IT&E International Group acquired the assets of Millennix Inc., a contract research organization (CRO) that provides comprehensive clinical research services for Phase I through Phase IV clinical trials. The Company's Millennix division also assists its clients with strategic and regulatory planning, as well as protocol development, investigator qualification and recruitment, study implementation and management, and data management. Clinical Research The Company's provides clinical research solutions to the pharmaceutical and biotechnology industry through a unique focus on specialty clinical studies in oncology, human immunology virus/acquired immunodeficiency syndrome (HIV/AIDS) and other complex infectious diseases, dermatology, gene therapy, immunologic therapy, biologics and other challenging metabolic and chronic diseases. In addition, IT&E International Group is able to manage the subtleties and special requirements of all phases of clinical research, such as Phase I, Phase II, Phase III and Phase IV clinical trials. Program Management and Outsourcing IT&E International Group offers a range of validation and compliance services from management consulting and computer systems validation (CSV) to clinical staff augmentation. The Company is engaged in designing, developing and implementing practices that protect the integrity of the computerized systems and equipment used in health product research and manufacturing processes. IT&E International Group ensures that these systems are maintained in a validated state throughout their entire lifecycle by following documented protocols and standardized procedures. The Company has the ability to deliver regulatory compliance services in fields, such as Guidelines Interpretation, Planning and Strategy, Corporate policies and procedures, Independent Vendor Audits and Assessments, SOP Generation and Revision, Gap Analysis, Risk Analysis - Business and Regulatory, Remediation, and Training end users and program managers. IT&E International Group also provides services in the CSV, CFR Part 11, CFR Part 210/211, CFR Part 58, Part 320, Part 820/QSR, GAMP4 (Good Automated Manufacturing Practices version 4.0), as well as European and Asian standards. In addition, the Company specializes in quality procedures, programs and management consulting in FDA regulated areas within the pharmaceutical and biotechnology industries, including audits, remediation, quality systems, and validation and qualification of processes, cleaning, environment, and computerized systems. IT&E International Group provides services focused around GxP compliance, validation and regulatory affairs for the life sciences industry, including CSV; 21 CFR Part 210/211-Good Manufacturing Practices; 21 CFR Part 11-Electronic Signatures and Electronic Records of Several other FDA and EMEA regulated areas; Computerized Systems Validation; Cleaning Validation; F
As Of: 10/07 00:00 ET
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