Skip to Content

Inspection Readiness

How we help with Inspection Readiness

A Health Authority (HA) inspection of a clinical trial can occur at any time, and preparation is critical to an efficient inspection that often leads to marketing approval. At Halloran, our quality, clinical operations, and regulatory experts understand exactly what the HA is looking for and how to prepare your study team including supportive documentation, so that inspector interactions bring your company to the next stage.

We use a seven-step Inspection Readiness (IR) process. By conducting an Inspection Readiness (IR) gap assessment, we can help you:

  • Establish objectives & standards
  • Review documents and conduct Subject Matter Experts (SME) interviews
  • Collate and categorize findings
  • Prioritize gaps, make recommendations based on risk criteria, and create an IR plan
  • Empower your teams to take ownership and remediate IR gap assessment findings

Halloran facilitates virtual or on-site inspection and audit readiness engagements, helping to prepare our clients for anticipated regulatory inspections (FDA, EMA, MHRA, PDMA, CFDA), diligence by investors, or potential partner evaluations. These engagements include inspection readiness preparedness, mock inspections and audits, storyboard preparation, behavioral interview training, and coaching. Halloran also leads clients through immediate remediation by authoring responses including strategies for remediation and developing corrective and preventative action plans (CAPA).

RELATED INSIGHTS

  • The International Council for Harmonisation draft guideline, ICH E6(R3), released on May 19, 2023, provides implications for Risk-Based Quality Management (RBQM).  Considering the updates, John Sikora, Associate Principal Consultant at Halloran presented at Momentum’s annual GCP Inspection Readiness conference. John’s presentation, “Examining the Impact of ICH E6 (R3) on RBQM, Oversight Procedures and GCP Inspection […]

  • Are you sponsoring a clinical trial and wondering how to develop an Informed Consent Form (ICF) that best facilitates the informed consent process? If you are, you’re not alone. If you aren’t, you should be. During our webinar, we will review the principles and requirements of informed consent, share common challenges and recommendations in the […]

  • In April of this year, the U.S Food and Drug Administration (FDA) released “A Risk-Based Approach to Monitoring of Clinical Investigations, Questions and Answers, Guidance for Industry.”  This guidance is noted to expand on the prior guidance for industry, “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring,” released in August 2013 and to […]