Consulting and support to clinical study applications

Consulting and support to clinical study applications

This service provides end-to-end support for preparing, submitting, and managing documentation for paediatric clinical studies, ensuring adherence to ethical standards and EU requirements. It covers submissions to EU and national authorities (Agencies for Medicines and Medical Devices, CTIS, EUDAMED) and Ethics Committees, as well as registration in international databases (e.g. ClinicalTrials.gov). Key outputs include regulatory advice, submission packages for medicines, devices, and combination products, and adaptation of materials to paediatric needs. The service also supports interactions with regulators and ethics committees, ensuring compliance with ICH-GCP, Regulation (EU) 536/2014, Regulation (EU) 2017/745, ISO 14155, and paediatric ethical guidelines. Coordination with Sponsors, CROs, investigators, and patient advocacy groups secures harmonised and efficient submissions across the study lifecycle.