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iCS has established an independent Quality Assurance organization that reports directly to the President & CEO and is responsible for corporate and site-specific quality assurance processes, oversight of quality control activities and the implementation of the Quality Management System, ensuring that all iCS locations are audit-ready and directing both internal and external audits. It is iCS' policy not to compromise quality and to address any quality concerns with our clients in a timely manner. By providing high quality services to our clients, we help to ensure the safety and efficacy of investigational medical therapies and devices. iCS is prepared to establish additional processes and agreements to govern quality activities specific to project or client needs.
The Quality Organization is also responsible for the development, implementation, and maintenance of the Quality Policy and Quality Management Plan and for leading the management review process. As part of the QA structure, iCS has Certified Quality Engineers (CQE), Certified Quality Auditors (CQA), and a Certified Software Quality Engineer (CSQE) on staff. Our CRO locations in Baltimore (MD), Indianapolis (IN), and The Woodlands (TX) have full-time Quality Assurance personnel on-site. iCS has designated the Corporate Director of Quality Assurance to be the Management Representative for all issues and activities related to Quality Assurance and Quality Control of processes and services.
The Director of QA is also a Compliance Specialist and leads the implementation of the inVentiv Health Corporate Compliance Program within the Clinical Solutions organization.. inVentiv Health's Corporate Compliance Program reflects our desire and commitment to conduct business in accordance with the highest ethical principles and all applicable laws and regulations. Our Corporate Compliance Program incorporates all the elements of the Office of Inspector General, U.S. Department of Health and Human Services' "Compliance Program Guidance for Pharmaceutical Manufactures" (the HHS-OIG Guidance) and is compliant with the California Health and Safety Code 119400-119402.
Patient privacy and the protection of personal health information are a critical component of our Quality System. iCS has taken steps to establish confidentiality, security and privacy requirements as related to personal information processed by iCS and to ensure that personal information processing activities are in compliance with applicable privacy, security and data protection laws. This guidance is provided to all iCS employees through the Corporate Quality Policy on Patient Privacy and Protection of Personal Information.
iCS' Quality System activities are based on Deming's model of the continuous improvement cycle (Plan-Do-Check-Act). That is why iCS has implemented programs to manage employee training, internal and vendor audits, deviations, corrective actions, and business continuity. All of our Quality Systems and processes are completely integrated across all locations via our secure, validated, state-of-the-art data center in Somerset , NJ.
Our offices in Baltimore, Indianapolis, and The Woodlands have been successfully audited by existing and potential clients 23 times in 2008. iCS has never undergone an inspection by FDA or any foreign regulatory agency, but has been involved in FDA inspections at some of the Sponsor clinical sites where we provide monitoring services. If you have questions or comments about inVentiv’s Quality System or Privacy Policy, or if you wish to schedule an audit of one of our locations, please contact our Director of Quality Assurance, Aida I. Pabon (apabon@inventivclinical.com).
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