GCP Audit
GCP offers a wide range of different GCP audits:
Investigator/Study Site Audits
Mock Pre-Approval Inspection Audits
Are you ready for an FDA inspection?
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.
A transformation towards risk-based monitoring has been taking place in the clinical research industry, and the publishing of ICH E6(R2) in 2016 has expedited the transition. You need to know if a vendor/site is adhering to federal laws and regulations governing clinical trials, or if a vendor/site has adequate quality systems for proper trial management.
Not being compliant can lead to failures, delays, unrecognized adverse events, and most importantly, loss of protocol and data integrity which could lead to a challenge of the clinical trial results by regulatory authorities. The GCP audit is the interface to ensure compliance. Our experienced auditors will identify potential risks and help ensure compliance issues don’t jeopardize the study.
Beyond site and monitoring audits, a GCP audit can be a full clinical trial audit over trial sites, an audit of a CRO conducting a trial on behalf of a sponsor, an audit conducted for the qualification and selection of a CRO, or a full clinical trial audit over systems and operations conducted by monitors. The GCP audit scope can include:
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Regulatory compliance for study integrity and essential document collection
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For International Review Board (IRB) or international ethics committees
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Phase 1 SOP development, training, or compliance
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Vendor Management
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Auditing data management and electronic data capture (EDC) systems
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Electronic medical records (EMR) integrity
The experts at GCC will ensure your organization is in compliance with Good Clinical Practices so you are organized and prepared when the inspection comes. Contact us today.
GCP Audit
GCC will:
Review SOPs for compliance within applicable regulations and guidelines and, if needed, create entirely new SOPs.
Review computer systems procedures and documentation, including those for security, back-up, and recovery
Review QA unit reporting structure, auditing practices, and CAPA procedures