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Health Authority inspections of clinical trials can occur unexpectedly, making thorough preparation essential for a smooth inspection process and potentially securing marketing approval. At Halloran, our team of experts in quality, clinical operations, and regulatory affairs is well-versed in the expectations of regulatory authorities. We understand how to prepare your study team and the necessary documentation to ensure a successful outcome.

We employ a comprehensive seven-step Inspection Readiness (IR) process to prepare for inspections:

Establish Objectives & Standards: Define the goals and benchmarks for inspection readiness
Review Documents and Conduct Subject Matter Expert (SME) Interviews: Assess existing documentation and gather insights from key personnel
Collate and Categorize Findings: Organize and categorize findings from the assessment
Prioritize Gaps and Make Recommendations: Evaluate risks associated with identified gaps and develop a tailored IR plan
Empower Teams to Take Ownership: Enable study teams to address and remediate identified gaps effectively
Conduct IR Training: Customize training sessions to address specific needs, including behavioral coaching, dos and don'ts, and best practices
Create Storyboards: Develop visual narratives to illustrate the study timeline and key trial aspects, aiding in inspection preparedness

Halloran offers virtual or on-site inspection and audit readiness engagements to assist clients in preparing for regulatory inspections from agencies such as the FDA, EMA, MHRA, PDMA, and CFDA. These engagements may include mock inspections, storyboard preparation, behavioral interview training, and coaching. We guide clients through immediate remediation efforts by crafting responses, strategies for remediation, and developing corrective and preventative action plans (CAPA).

Conducting an IR gap assessment is the initial step in our preparation process. Through this assessment, we help clients establish objectives, review documents, and prioritize gaps based on risk criteria. Our customized IR plans empower teams to take ownership of remediation efforts and ensure readiness for inspection.

Mock inspections are another valuable component of our preparation process, allowing participants to simulate real-world inspection scenarios and identify areas for improvement. We recommend involving primary SMEs comfortable discussing key trial issues, ideally beginning IR planning six to twelve months before regulatory submission to allow ample time for remediation.

By partnering with Halloran, clients can navigate the complexities of inspection readiness with confidence, ensuring compliance with regulatory standards and positioning their studies for success.

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