|
|
Good Clinical Practice The GCP requirement for independent audits is addressed by Qualitas. Qualitas has conducted GCP audits world-wide. Services undertaken to meet client needs include:
• Investigator site audits Audits of in-house and on-site study documentation, including pharmacy.
• CRO audits Pre-contract and study audits of facilities, organisation and documentation.
• Clinical study report audits Audits of CSRs to assure accurate reflection of study conduct and data.
• Preparation for Regulatory Inspections Simulated regulatory inspections in-house or on-site to assure necessary systems and documentation are in place.
• Provision of QA Function Undertaking a variety of QA duties.
• Preparing SOPs Advice and preparation of SOPs.
Audit times, including preparation and audit reports, are illustrated below: • Investigator audit, with 1.0 day on-site: 4.0 day • Further investigator audits within same study: 3.0 day • Study reports: please ask. Audits result in audit reports and audit certificates, as applicable.
Outline your needs in Request Information for a response to include audit times and costs. |
