ICH GCP E6(R3) Gap Assessment & Transition Review
Structured support for aligning with updated GCP standards
Tailored Support by Stakeholder Type
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Sponsors- Implementation of sponsor-level quality management frameworks
- Clarification of oversight responsibilities in outsourced models
- Alignment of internal documentation with risk-based decision processes
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CROs- Harmonization of operational workflows across trials and sponsors
- Upgrade of staff training for R3-specific monitoring, documentation, and data handling
- Standardized reporting templates for sponsors and auditors
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Vendors- Mapping of core technical and operational activities (e.g., data transfer, IT systems) to GCP R3 expectations
- Development of CAPA frameworks and internal risk assessments
- Support in aligning with sponsor oversight models
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Clinical Sites- SOP updates to reflect centralized and remote monitoring
- Readiness for new models of data capture and source verification
- Guidance on integrating quality culture and continuous training
Why Transition Consulting Matters
- Focus on Risk-Based Quality
We help adjust your SOPs, monitoring plans, and vendor oversight models so they reflect these risk-based expectations—without overloading your team. - Updated Compliance Requirements
Our experts map your current practices to the new regulatory expectations—ensuring your operations are both compliant and audit-ready. - Operational Efficiency & Data Quality
We help you simplify workflows, reduce duplication, and build systems that improve both performance and compliance.
How We Structure the Engagement
Gap Analysis
Assessment of SOPs, workflows, and systems to identify deviations from R3.
Risk Prioritization
Ranking gaps by regulatory impact and operational risk to guide focused remediation.
Transition Roadmap
Defined short- and long-term actions, milestones, responsibilities, and KPIs.
Staff Training
Custom training programs based on actual role needs and audit expectations.
Continuous Verification
Optional follow-up to measure implementation outcomes and reinforce quality improvements.
Scope of Work
Step-by-step structure of the consulting engagement
- Virtual kick-off meeting to confirm objectives and timelines
- Collection and organization of SOPs, policies, training records, and other quality documents
- Review of documentation hierarchy and governance structure
- High-level review of selected SOPs and workflows
- Comparison of current practices with ICH GCP E6(R3) requirements
- Identification of short-term and high-risk compliance gaps
- Assessment of data integrity, sponsor oversight, vendor management, and quality systems
- Mapping findings to R3 standards with risk and impact analysis
- Initial recommendations for SOP updates, training, and process adjustments
- Preparation of a preliminary Gap Assessment Report
- Consolidated Gap Assessment Report
- Strategic Transition Roadmap with prioritized steps and timelines
- Virtual debrief session to review findings and discuss implementation approach
- Follow-up Q&A session
- Advisory input during SOP revision, training, or internal alignment
- Additional support upon request
Timelines & Pricing
Estimated duration:
3–5 weeks from kick-off to final report
Fixed-fee package:
50–60 consulting hours, priced as a single engagement
Scope adjustments:
Agreed in advance based on project complexity and document availability
Contact Us
Phone number: +34 625263964
Email: info@theqarp.com
Email: info@theqarp.com