The EPTRI Centralised Services are advice or hands-on activity transversal to the TRPs and intended to support any step of the paediatric research conducted in the basic, pre-clinical and translational setting. Centralised services are directly provided by the EPTRI CMO and dedicated experts in line with their expertise. These services may be proposed to be conducted in collaboration with other RIs, paediatric networks and initiatives.
Advice on the design of non-clinical specific studies
The service provides scientific and regulatory advice on technical and methodological issues encountered in pre-clinical phase. Researchers may encounter these challenges while they prepare preclinical experimental protocols covering new targets discovery, proof of concepts that regulatory studies required in the paediatric developmental plans. As an example, these services include tailored advice regarding the choice and use of paediatric animal models, cell, tissues and organoid studies, in vitro/in silico studies.
Advice on the translation of paediatric clinical studies based on preclinical results
This service is aimed to advice on how to translate preclinical results (predicted efficacy safety, dosing, biomarkers, toxicity, adverse events) into paediatric clinical trials and studies design to optimise the clinical relevance of the results
Advice and/or document preparation for regulatory and ethical procedures
This service is aimed to provide strategic advice on the ethical, legal and societal issues related to the discovery and development of paediatric products, facilitating compliance with requirements and best practice standards. As an example, this service will provide consultancy on paediatric developmental plans, support in the reply to queries from the Regulatory Agencies with reference to paediatric preclinical, safety, or pharmaceutical studies. Moreover, this service comprises the preparation of the documents needed to be compliant with the regulatory part of the marketing authorization process of a paediatric product.
Advice and/or reports preparation for health technology assessment (HTA) studies
This service advice on the assessment of the overall impact of the introduction of a new paediatric technology or medicinal products/medical devices in terms of safety, efficacy, economical and organisational burden through a multi-dimensional approach. The users will be supported for the preparation of Health Technology Assessment (HTA) report.
This service will support users requiring pharmacometric applications using mathematical models based on biology, pharmacology, and pathophysiology, along with statistical models. Applications are intended in the preclinical setting and may also include models for PK or PK/PD characterization, exposure-response analysis, optimization of dosing schedules in paediatric sub-groups of population, early clinical studies and treatments optimization
Data FAIRs principles application
This service will allow users to access tools for accessing, integrating, analysing, sharing and re-using paediatric data according to the FAIR principles. Moreover, users will receive advice on the application of the GDPR to data privacy and anonymization, interoperability, and liability issues.
Support in application to public funding opportunities
This service provides “expert support” to identify public grants opportunities in research areas related to EPTRI activities as well as support in designing, organising and applying for funding. A database of funding opportunities will be created and searched to provide reports of suitable funds in the users’ field of interest.