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        Quality Management Services

        Clinical research represents a major part of the immense cost of drug development. Significant (and all too common) extra expenses and delays to market approval can be avoided by doing clinical research right the first time.

        IKSA offers comprehensive and cost-effective Quality Management Services (QMS) for the planning, execution and reporting of clinical research studies according to Good Clinical Practice (GCP).

        Study core document review

        IKSA helps clients draft GCP-compliant and user-friendly clinical research ‘core’ documents to achieve harmonised, good quality clinical research and effective study reporting.

        Documents include:

        • Investigator Brochures
        • Protocols
        • Informed consent forms
        • Case report forms
        • Study operations manuals
        • GCP-required documents for ‘green-light’ for individual site initiations
        • Clinical study reports
        • Contract review (Investigators and vendors / CROs)

        Auditing

        IKSA provides comprehensive audit support for clinical research:

        • Annual audit plans for clinical research
        • CRO, Phase I unit, and other vendor selection
        • Study site audits
        • Trial Master File audits
        • ‘For cause’ audits (investigation of potential fraud)
        • Due diligence audits
        • Clinical research systems audits
        • Computer compliance reviews
        • Pharmacovigilance audits

        SOPs

        IKSA helps its clients to create and improve its SOPs for clinical research and QA operations.

        Building a clinical research Quality Management System (QMS)

        IKSA helps clients who are new to clinical research to create a robust QMS to build quality into its studies, for great savings in time and expenses.

        Continuous improvement

        IKSA provides tailor-made services to its clients to support continuous improvement to its clinical research operations, through tailor-made trouble-shooting.

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