Services Provided
Gap Assessment & Current State Evaluation
Every engagement begins with a comprehensive assessment of the current state. This includes reviewing study documentation, governance structures, sponsor-CRO relationships, SOPs, quality systems, oversight practices, and key study plans to understand how the study is actually being managed.
The goal is to identify gaps between documented processes and operational reality before they become inspection findings.
Risk Assessment
Using a risk-based approach, we assess the study for potential inspection vulnerabilities that could impact subject safety, data integrity, regulatory compliance, or sponsor oversight.
This review may include:
- Clinical protocols and amendments
- Monitoring plans
- Data management plans
- Vendor oversight plans
- Risk management documentation
- Contracted obligations and responsibilities
- Inspection history and known issues
The outcome is a prioritized assessment of inspection risk areas requiring attention.
* Customized BIMO tools available
TMF Evaluation & Inspection Readiness
The Trial Master File is one of the primary sources regulators use to assess how a study was conducted. An incomplete, inaccurate, or poorly maintained TMF can significantly increase inspection risk, regardless of how well the study was managed operationally.
We evaluate the TMF to determine whether it accurately reflects study conduct, sponsor oversight, and critical decision-making throughout the lifecycle of the trial.
This assessment may include:
- TMF completeness and quality review
- Identification of missing, incomplete, or inconsistent documentation
- Review of sponsor oversight documentation
- Evaluation of filing practices and inspection readiness
- Assessment of document quality and contemporaneous records
- Identification of TMF-related inspection risks
- Recommendations for remediation and sustainable TMF practices
The goal is not simply to improve TMF metrics, but to ensure the TMF tells the complete story of the study and can withstand regulatory scrutiny during an inspection.
Sponsor Oversight Review
Effective sponsor oversight is a critical component of inspection readiness.
We evaluate sponsor oversight practices and accountability structures, including:
- Vendor oversight processes
- RACI and responsibility matrices
- Functional ownership assignments
- Escalation pathways
- Oversight committee structures
- Documentation of sponsor decision-making
The objective is to ensure responsibilities are clearly defined, documented, and consistently executed.
SOP & Process Alignment
Many organizations have SOPs that do not accurately reflect current operational practices.
This assessment evaluates:
- SOP alignment with study execution
- Process consistency across functions
- Documentation practices
- Governance and decision-making processes
- Compliance with GCP and regulatory expectations
Recommendations focus on creating practical, sustainable processes that teams can consistently follow.
CAPA Development & Inspection Storyboards
Once risks and gaps are identified, we work collaboratively with teams to develop practical solutions.
Support includes:
- CAPA strategy and development
- Remediation planning
- Risk mitigation activities
- Inspection storyboards
- Documentation of key study decisions and historical events
- Inspection readiness preparation
The goal is not only to correct deficiencies but also to create a clear, defensible narrative that demonstrates sponsor oversight, compliance, and operational effectiveness during an inspection.
Wendy Botwick
With more than 30 years of experience in clinical operations, sponsor oversight, compliance, and inspection readiness, I help biotech companies identify risks, strengthen oversight, and prepare for successful regulatory inspections.
My experience spans early development through Phase 3 studies, with a focus on building practical, sustainable processes that support both operational excellence and inspection readiness.