Paediatric Clinical Research Services
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Support for non-clinical to clinical transition, including paediatric funding and grant assistance
Comprehensive multidisciplinary methodological and scientific support for paediatric clinical study design, protocol development, and reporting
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 methodological and pharmacometrics support for paediatric clinical research, including innovative study designs and dose extrapolation
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 patient and family engagement and involvement
Regulatory, ethical, and governance support for paediatric clinical studies
Clinical data management, statistical analysis, and digital/real-world data integration
Specialised paediatric clinical units for patient recruitment, trial conduct, and age-appropriate care
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.
