GCP Audit

It's not merely important, it's critical to ensure your site's operations comply with Good Clinical Practice (GCP) Standards and Good Clinical Consultants provides an array of GCP and clinical quality services to fit your needs.

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Quality Management System

At GCC, we help our clients to develop Quality Management Systems that standardize current processes and address gaps to ensure consistent, accurate and reliable standard procedures across all business functions that are compliant with global regulatory standards.

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SOP Development

Clinical research Standard Operating Procedures (SOPs) can be insufficient, too technical or poorly written, which impacts clinical operations and wastes time and money. When regulatory authorities come to inspect, non-compliant SOPs are most often cited.

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Vendor Management

As the volume and complexity of outsourcing increases, it becomes important to implement a risk-based approach to vendor oversight. Regulatory agencies expect that sponsor companies will ensure qualified personnel are working on their behalf, following GCP-compliant processes, and have adequate controls in place.

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Inspection Readiness

Inspection Readiness is achieved by implementing a QMS and auditing the QMS to ensure it is functioning properly. We design QMS with SOPs that define processes for hosting inspections, responding to inspections, entering inspection findings into CAPA and resolving.