Clinical Quality Assurance Services

Clinical Quality Assurance

A strong Clinical Quality Assurance (CQA) framework is essential for maintaining the integrity, reliability, and compliance of clinical programs. Our CQA services provide proactive to reactive quality support to sponsors and CROs, ensuring adherence to regulatory standards and industry best practices. Ensure Clinical Quality & Compliance with Expert Support.

Comprehensive Clinical Auditing Services

A structured auditing approach is essential for identifying compliance gaps, mitigating risks, and ensuring regulatory readiness. Our clinical auditing services help organizations maintain compliance with global regulatory expectations.

Our Clinical Auditing Solutions

• Compliance Audits – Conducting audits across GCP, GCLP, GLP, non-GCP, PV, and REMS to ensure adherence to clinical and laboratory standards.
• Gap Assessments & Mock Inspections – Identifying potential compliance risks and preparing teams for regulatory scrutiny.
• For-Cause & Due Diligence Audits – Investigating compliance concerns and evaluating potential risks before regulatory action.
• Vendor & Site Qualification Audits – Assessing CROs, investigators, and sites to ensure they meet regulatory and operational requirements.

Our Inspection Readiness Solutions

• Clinical Study Gap Assessment – Identifying and addressing compliance gaps in clinical trials to mitigate regulatory risks.
• Remediation & Documentation Support – Expert guidance on remediation strategies, including storyboarding, EDC, DMF, SOP development, and CAPA implementation.
• Inspection Readiness Training – Customized training on regulatory expectations, sponsor responsibilities, and ICH E6 compliance to ensure teams are well-prepared.
• Mock Regulatory Inspections – Conducting simulated health authority inspections to evaluate and enhance clinical trial readiness.

Medical Device Clinical Quality Support

At ProPharma, we provide expert clinical consulting services to medical device and diagnostics companies. Helping to navigate and ensure compliance to complex global regulatory requirements while achieving operational excellence.

Regulatory & Quality Support for Medical Devices

Our team specializes in supporting the unique requirements of medical device companies in meeting international compliance standards, including:

• Design Control Requirements – Ensuring clinical trial and study activities align with international regulations for product design and development.
• Clinical Trial File Management – Expert guidance in maintaining regulatory-compliant trial master files.