GCP Inspection readiness program

Pre-Inspection Readiness and Inspection Support Services

KOSIERADZKI.com  provides structured support for clinical trial sites in preparation for regulatory inspections and during inspection conduct. Services can be tailored to the scope, timing, and complexity of the inspection.

1. Comprehensive Pre-Inspection Readiness Program (2–4 days)

The duration depends on the number of enrolled subjects; for smaller studies, 2–3 days are typically sufficient. The structure and volume of source documents (SD) may significantly influence the scope and timing.

Scope of services includes:

• On-site pre-inspection readiness visit conducted 2–3 weeks prior to the anticipated inspection, covering review of study documentation and operational processes

• Pre-inspection training session (1–2 hours) for key study team members, focusing on inspection expectations and critical risk areas

• Mock inspection interviews with key personnel (Principal Investigator, Study Coordinator, Investigators)

2. Focused On-Site Pre-Inspection Review (1 day)

• Single-day on-site visit performed approximately 2–3 weeks before the inspection

• Targeted review of documentation completeness, process compliance, and site readiness

3. Inspection Hosting and Support (Inspection Duration)

• On-site support during the regulatory inspection

• Oversight of inspection flow, coordination with site staff, and status monitoring and reporting throughout the inspection

4. Remote Pre-Inspection Training (1–3 hours)

• Online training session for the study team

• Coverage of regulatory inspection principles, roles and responsibilities, communication strategies, and common inspection findings

OUR Experience: FDA BIMO / EMA / MHRA