Industry
Clinical Facilities
GCP audits, inspection readiness and quality support for clinical trial sites and units.
Overview
Clinical facilities and trial sites carry direct responsibility for subject safety and data integrity, and are subject to GCP inspection by regulators worldwide.
PharmExpert supports clinical sites and units with GCP audits, inspection readiness and quality-system improvement that protect subjects and data alike.
Regulatory challenges
- ICH E6(R2/R3) GCP compliance
- Informed consent and subject protection
- Source-data integrity and documentation
- Investigational-product accountability
- Inspection readiness
How we help
- GCP site and system audits
- Inspection-readiness preparation
- Quality-system and SOP development
- Data-integrity assessment
- GxP training
Relevant Services
Quality & compliance support for clinical facilities
Talk to an independent PharmExpert specialist about your GxP, regulatory or quality challenge. We respond within one business day.