Paediatric Clinical Research Services
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Support to move from non-clinical to clinical phase
Comprehensive Multidisciplinary Methodological and Scientific Services
This service provides specialised medical writing for paediatric clinical research, ensuring clarity, scientific rigour, and compliance with ethical and regulatory standards. Services cover the preparation of Study Protocols/Clinical Investigation Plans, Investigator’s Brochures, and IMPD/Investigational Device Dossiers, feasibility assessments, and expert input on study design, endpoints, and inclusion/exclusion criteria tailored to paediatric cohorts. It also supports drafting of reporting outputs, including clinical study reports, interim/annual reports, and lay summaries co-created with patients and families. Advanced strategies are applied to optimise visit schedules, reduce patient burden, and provide tailored approaches for ATMPs and medical devices.
Advanced tools for Paediatric Clinical research
This service develops and applies innovative study methodologies tailored to paediatrics and aimed at gaining evidence with reduced timing and efforts, thus speeding up licensing of products for human use.
Young Patients' Involvement and Engagement
Clinical Data and Analysis
Specialised Paediatric Clinical Units
This service leverages specialised paediatric units and clinics to identify, recruit, and follow up patients, ensuring access to diverse populations, expert staff, and sustainable engagement, including in rare and ultra-rare disorders. It supports early-phase and first-in-human studies, with safe and ethical management of patients and healthy volunteers, in facilities fully equipped for paediatric needs. Services include patient recruitment/retention, administration of drugs or devices, age-appropriate study visits, safety assessments, and collection of clinical data and biological samples. Outputs include validated datasets, monitoring and safety reports, full clinical documentation, and comprehensive regulatory-ready packages to support trial submissions, publications, and engagement with patients and families.