Clinical Investigator Site Audits

isaAPSI can help you develop and/or execute your site audit plans for all phases of clinical research.

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Clinical Study Report (CSR) Audits

csrAPSI can conduct audits of your CSRs to help ensure that your clinical trial results are reported accurately.

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Inspection Readiness

inspection readinessLet APSI help you prepare for and/or support inspections at your company or site.

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Gap Assessment and Analysis

gap analysisFor any area within your quality system, APSI can review your written procedures and documentation for gaps and provide recommendations tailored to your infrastructure and needs.

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Standard Operating Procedures (SOPs)

sop devAPSI can conduct SOP gap analyses and/or develop key procedures based on your organization’s infrastructure, activities, GCP & GLP requirements and best practices.

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