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Compliance Implementation Services (CIS), a pharmaceutical compliance consulting firm, is pleased to announce that it is expanding its Clinical R&D Compliance services with additional tools for Good Clinical Practice (GCP) Benchmarking and Key Performance Indicator (KPI) development.
CIS applies metrics to GCP compliance areas, allowing clients to routinely monitor, evaluate, and remediate clinical compliance risks. CIS uses its proprietary Inspection Readiness Profiles and GCP Regulatory Requirements Inventory tools to internally benchmark the current state of a sponsor’s GCP Quality Assurance and Quality Control systems and supporting controlled documents. This internal benchmarking identifies GCP compliance risks, provides a data-driven list of areas for improvement, facilitates rapid process enhancements, and enables application of root cause analysis and Corrective and Preventative Action (CAPA) planning for more complex compliance issues. Internal benchmarking is an early and essential step in establishing GCP Key Performance Indicators (KPIs), leading to a new measure of sponsor control and oversight of GCP compliance.