In conversations with clients, we’ve seen regulatory inspections moving into earlier phases of development. Whether at Phase III or earlier, readiness at all stages ensures trials remain on track and in compliance.
As health authorities increasingly shift inspections to earlier stages of clinical development, organizations must adopt proactive strategies to manage compliance effectively. Early inspections present an opportunity to identify and address potential issues well before they jeopardize trial integrity or delay approvals.
To support your inspection readiness, we've prepared a checklist of best practices for every phase of clinical trials.
Inspection Readiness Checklist
- Implementing a Proactive Inspection Readiness Program
- Define standards, conduct audits, train staff, and maintain documentation.
- Use mock inspections and tracking metrics to address issues early.
- Robust Quality Management Systems
- Establish clear processes and ensure SOPs are up-to-date and reflective of current practices.
- Implement document control and conduct internal audits to detect issues early.
- Ensuring Protocol Compliance
- Develop strategies for maintaining adherence to the study protocol.
- Create systems for managing and documenting protocol deviations.
- Comprehensive Documentation and Record-Keeping
- Maintain an up-to-date Trial Master File (TMF).
- Ensure accurate and timely data entry in case report forms (CRFs).
- Document informed consent properly and thoroughly.
- Effective Communication and Training
- Hold regular team meetings to discuss compliance issues.
- Provide ongoing GCP training tailored to specific roles and responsibilities.
- Prepare staff for interaction with inspectors, including "do’s and don’ts" training.
Integrating these practices into your operations ensures inspection readiness becomes second nature, not a last-minute scramble. By embedding readiness into every phase, you can confidently meet regulatory expectations and maintain trial success.
Inspection readiness is an ongoing effort. While this checklist provides a strong foundation, achieving seamless readiness across all phases requires thoughtful planning and alignment.
