CRO SERVICES
Quality Assurance
Quality Oversight
CRC is committed to exceeding the quality standards demanded by our Sponsors, patients, and regulatory authorities.
The quality of our work is vital to our mission of bringing better medications to patients. We are committed to maintaining, supporting, checking, and improving our quality systems to exceed the quality standards demanded by our clients, patients, and regulatory authorities.
Our Quality Management System (QMS) comprises our mechanisms for ensuring that all our services are performed to the highest ethical standards, conform to all relevant regulatory requirements, and satisfy contractual obligations.
CRC’s comprehensive quality system is constructed from the following key elements:
- Process
- Compliance
- Quality Assurance
- Risk
- Reporting
Our QMS is structured to ensure:
- Ensure that all client requirements are met
- Enable employees to conform to and document GxP, and Regulatory requirements
- Ensure that all company activities are controlled and documented
- Provide guidance for staff development and training
In addition, we have the flexibility to operate with our client’s SOPs when requested.
The following QA services are provided on a stand-alone or project-specific basis.
Audits/ assessments cover:
- Phase I – IV GCP audits
- Operational vendor/supplier audits and qualifications
- Investigational site audits
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