Risk Mitigation: Gap Analysis

Source: Halloran Consulting Group


Global regulators are becoming increasingly vigilant in their oversight of clinical research, steadily increasing the annual number of Sponsor inspections they conduct. Sponsors that proactively assess process and organizational risks can act before these risks become findings in a regulatory inspection.

Objective Assessment
Halloran's gap analyses provide an objective assessment of organizational efficiency, compliance with applicable regulations, and adequacy of quality systems. A successful gap analysis identifies necessary changes in process, organization, and resources, and maps out a systematic approach for implementing solutions that effectively minimize risks to the organization.

Mitigation Strategies
At Halloran, we never deliver just an assessment of current performance but always provide strategies for risk mitigation moving forward. We conduct high-level organizational assessments, as well as detailed evaluations of specific functional areas, resources, processes, and quality systems for pharmaceutical, biotechnology, medical device and clinical service organizations across many therapeutic areas. 

Process Analysis

  • Regulatory compliance
  • Audit and inspection readiness
  • Vendor oversight
  • Alignment with best practices and industry standards

Organizational Analysis

  • Strategic plans
  • Organizational structure design and optimization
  • Quality systems
  • Resource allocation
  • Roles and responsibilities
  • Resource scale-up/down strategies
  • Training and skills
  • Team performance