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.
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.
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.