GCP Gap Analysis

What is a gap analysis?

A gap analysis is a powerful technique used by businesses and organisations to determine the steps needed to move from the current state to the desired, future state.

When it comes to ICH Good Clinical Practice (GCP), a gap analysis can be used to review clinical research systems in a systematic way, identifying areas that require further development.

At Paul Cross Consulting (PCC), we offer gap analyses for various types of clinical research quality systems, from sponsor systems to investigator sites, CROs, and laboratories.

Our systematic approach to gap analysis focuses on people, their competencies and training, processes and procedures, project management, and facilities, resources, and equipment.

Our consultants take a logical and pragmatic approach to gap analysis, assessing the current state of a quality system and identifying any areas of non-compliance with regulatory requirements. We then work closely with our clients to develop a comprehensive action plan that addresses the gaps identified in the analysis.

Whether you need a gap analysis for a specific departmental process or for your organization’s entire quality management system, PCC is here to help. Our goal is to provide you with the support you need to ensure that your clinical research systems are robust, effective, and compliant with regulatory requirements.

Typical agenda (on-site visit)

  • Opening meeting
  • Review of people, their training and competencies
  • Review of current systems, processes and procedures
  • Review of facilities, resources and equipment
  • Interviews with key personnel
  • Closing meeting / presentation of gaps identified


  • A gap analysis report is circulated, including both gaps and recommendations
  • Client prepares a corrective action preventative action (CAPA) plan for PCC to review (optional)

Contact us today to learn more about our gap analysis services and how we can help you achieve your quality system goals: info@paulcrossconsulting.com

%d bloggers like this: