Quality Assurance in Clinical Trials in Kenya
Comprehensive Quality Assurance for Clinical Trials
Our quality assurance team is committed to upholding the highest industry standards at every phase of your clinical trial. We develop and implement robust quality systems, conduct comprehensive audits, and ensure regulatory compliance, safeguarding the integrity and reliability of your study data.
With over two decades of experience, we conduct thorough audits of internal processes, procedures, departments, and all study-related services to maintain excellence.
Our Key Quality Assurance Services:
- Investigator site audits
- Quality event management/CAPA
- Vendor audits
- Process and system audits
- Regulatory inspection preparation and support
- Regulatory GxP training
- Tracking and management of document control
Trust our expertise to ensure compliance, reliability, and success in your clinical trials.
- CRO Services
- Central and Bioanalytical Lab
- Clinical Biostatistics
- Clinical Data Management
- Clinical Monitoring
- Clinical Trial Management
- Clinical Trial Planning and Design
- Feasibility
- Medical Monitoring
- Medical Writing
- PK/PD and PBPK modeling
- Project Management
- Quality Assurance
- Regulatory Affairs
- Safety and Pharmacovigilance
- Study Start-up
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