A comprehensive analysis of Part 1 RFI trends and Best Practices
This white paper highlights the main drivers behind regulatory requests for information (RFIs) in Phase 1 clinical trial submissions, based on recent Belgian data. It offers targeted recommendations on protocol design, safety, toxicology translation and regulatory completeness to help decision makers reduce regulatory risk, address common pitfalls and accelerate study authorization.
What you'll find in this factsheet:
- Analysis of RFI trends in BelgiumReview real-world RFI patterns since implementation of the EU CTR, including the distribution of queries across protocol, investigator's brochure and supporting documents.
- Key protocol pitfalls and solutionsGet actionable advice on common protocol RFI themes: safety thresholds, stopping rules, dosing strategies, eligibility, PK sampling and regulatory reporting requirements.
- Investigator's brochure: toxicology, pharmacokinetics and regulatory essentialsLearn how to address frequent IB queries, especially in nonclinical data translation, species selection, study design and GLP documentation.
- Best practices for cross-functional document alignmentStrengthen early-phase submissions by applying integrated scientific rationale and clear operational criteria across regulatory documents.