Specialist add-on · Toolkit D
Paediatric Development Add-On
Extend the core system with paediatric planning, commitments, consent and assent, safety monitoring, and age-appropriate formulation controls.
What it helps control
Operational support
Helps teams coordinate paediatric obligations, study evidence, and population-specific safeguards.
How it helps your team
Add product-specific controls without rebuilding the core development system.
Designed for
Paediatric development, clinical, safety, formulation, Regulatory Affairs, and ethics-facing teams.
Included files
Know exactly what the toolkit contains
The file names below show what is included. File contents become available only after purchase.
Word documents
- Paediatric Development Plan
- Paediatric Investigation Plan / iPSP Template
- Paediatric Consent / Assent Template
- Paediatric Safety Monitoring Plan
- Age-Appropriate Formulation Plan
Excel workbooks
- Paediatric Commitment Tracker
- Paediatric Study Tracker
- Consent / Assent Version Tracker
- Paediatric Safety Evidence Tracker
Related toolkits
Continue within specialist add-on
Biologics Development Add-On
Extend the core development system with biologics-specific CMC, immunogenicity, species relevance, comparability, viral safety, and potency controls.
BCell & Gene Therapy / ATMP Add-On
Extend the core system with ATMP-specific regulatory, identity, custody, long-term follow-up, CMC, and source-traceability controls.
COncology Development Add-On
Extend the core system with oncology-specific dose escalation, DLT, response assessment, combination risk, and safety-review controls.