Clinical Quality, GCP Auditing & Trial Oversight
A boutique clinical quality and operations firm supporting biopharma and biotech sponsors with risk-based oversight.
Explore our SERVICES
GCP Auditing (Clinical Sites & Vendors)
GCP Auditing (Clinical Sites & Vendors)
GCP Auditing (Clinical Sites & Vendors)
Risk-based investigator site audits, CRO and clinical vendor qualification assessments, and ongoing oversight aligned with FDA, Health Canada, and ICH-GCP expectations.
Clinical Trial Management and Monitoring
GCP Auditing (Clinical Sites & Vendors)
GCP Auditing (Clinical Sites & Vendors)
Strategic and operational oversight supporting efficient trial execution, risk management, and quality compliance from start-up through close-out.
Patient Recruitment and Site ENgagement
GCP Auditing (Clinical Sites & Vendors)
Patient Recruitment and Site ENgagement
Targeted recruitment and site engagement strategies designed to strengthen enrollment, retention, and site performance.
Vendor Management and Oversight
Standard Operating procedures (SOP)
Standard Operating procedures (SOP)
Structured vendor qualification, governance, and performance monitoring frameworks that strengthen sponsor oversight and accountability.
Standard Operating procedures (SOP)
Standard Operating procedures (SOP)
Standard Operating procedures (SOP)
Fit-for-purpose SOP development and quality documentation frameworks aligned with regulatory expectations and operational realities.