What is a gap analysis?

A gap analysis is a technique used by a business or organisation to determine what steps need to be taken in order to move from its current state to its desired, future state. With regards to GCP, the gap analysis reviews clinical research systems in a systematic way; identifying which areas require further development. The gap analysis takes a systems audit approach, however, the method can be applied to almost anything: from a set of departmental processes through to an organisation’s entire quality management system.

Paul Cross Consulting offers gap analyses for various types of clinical research quality system, from sponsor systems through to investigator sites, CROs and laboratories. PCC takes a systematic approach to gap analysis, focusing on people, their competencies and training, processes and procedures, project management, and facilities, resources and equipment; in a logical and pragmatic way.

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)

*Please note, all work is completed virtually at the current time, due to the Covid-19 pandemic.

Contact PCC for further information: info@paulcrossconsulting.com