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Auditing &Quality Assessment
Standard Operating Procedures Development
Tailored Training Programs
Regulatory Inspection Readiness &Preparedness
Quality Management System Development and Support
GMP Related
Auditing &Quality Assessment
Investigator Site Audits (ISA), including routine and for-cause audits
Vendor Assessments &Audits, including but not limited to Phase I Units, CROs, Laboratories, IP depots and warehouses
Protocol/ Informed Consent Form Audits
Study/ Trial Master File Audits
Clinical Data Audits (Database &TFLs)
Clinical Study Reports (CSR) Audits
Due diligent activities