Standardized Processes and Systems Audit

Our team approach to quality management begins in the implementation phase and exists within all systems and processes throughout the lifecycle of a program or clinical trial. The approach includes the incorporation of standardization through education, written procedures, the establishment of defined metrics, and auditing.

Our Quality Management Systems

We offer the following Quality Management Services:

Quality Management Plans
Metrics for Performance and Compliance
Independent Data Auditing
21 CFR Part 11 Compliance
Standard Operating Procedures
Regulatory Master File Review
Preparation and Facilitation of Third Party Audits
Site GPC Audits
Vendor Qualification Audits

Need help setting your next clinical trials for success in Africa?

Contact us for Protocol design, Regulatory Strategy, High enrolling sites & Investigators, Clinical Monitoring, Site management, Data management, Biologic material transfer  & much more.
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