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 AnalysisAssessment of SOPs, workflows, and systems to identify deviations from R3.
- Risk PrioritizationRanking gaps by regulatory impact and operational risk to guide focused remediation.
- Transition RoadmapDefined short- and long-term actions, milestones, responsibilities, and KPIs.
- Staff TrainingCustom training programs based on actual role needs and audit expectations.
- Continuous VerificationOptional 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