GCP Site Audits & Inspection Readiness Services

Long gone are the days where teams frantically scramble to prepare for an impending regulatory agency inspection or a Sponsor audit. Creating countless notes to file to correct errors and justify deviations or pleading for additional copies of essential documents at the eleventh hour are simply no longer the norm.

To be inspection-ready, clinical trial documentation and systems are to be kept up to date on a regular and continuous basis.

Inspection readiness strategies and activities must be planned and built in throughout the lifecycle of a trial allowing Sponsors, CROs and clinical trial sites to meet the regulatory agencies' (FDA, Health Canada, MHRA, EMA, etc.) expectations as well as the ever evolving ICH guidelines. Sponsors are now required to be inspection-ready at all times.

Are you inspection ready? Ask us about our Inspection Readiness Consulting services!

Inspection readiness should be built into all processes during the clinical development of a product. With good planning upfront at the beginning of the program, many of the issues found during an inspection can be either prevented or their impact lessened.

Inspection readiness strategic planning can be incorporated in the following areas: 

• Standard Operating Procedures
• CRO and Vendor selection, management and oversight
• Investigator selection and management
• Clinical site management
• Monitoring procedures and activities
• Evaluation and reporting of adverse events and serious adverse events
• IMP accountability and documentation
• Trial Master File oversight
• Regulatory documentation

Conducting a Program Review and Gap Analysis of your current clinical operations plans, procedures and projects or of your clinical studies, allows for an objective evaluation of their 'health' and provides you with an opportunity to proactively address any identified gaps, furthering your continuous internal quality and compliance efforts.

TMF quality review contributes to ensuring that your Trial Master File (TMF) complies with Good Clinical Practice (GCP) standards by rapidly identifying problematic areas and offering actionable insights for potential remediation.  

Our team will conduct a thorough review of 'critical to quality factors' for Sponsors and CROs to determine TMF Health. This review will focus on key indicators of quality, completeness and timeliness.