Centralised Services

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Centralised services are provided by the Central Hub and partner Institutions covering:

Document Repository and e-Library

The service gives the opportunity to store, treat and preserve research results, offering a central location where authorized users can upload and download files.

It has a documents’ repository to provide users with a centralised e-library for storing, archiving, and retrieving documents and data produced as a result of research activities.

The e-Library is provided of a simple User Interface to access this service for searching, browsing, and finding data and documents.

Access to e-learning and training

A set of trainings, e-learning courses and webinars on the themes of the paediatric preclinical and translational research is under development.

The training contents will vary from general issues of interest (such as ethics and regulatory) for paediatric medicines development, including orphan drugs, advanced therapy and medical devices, to dedicated training activities in EPTRI’s thematic research fields.

The e-learning courses will be available for Academia and no profit organisations, industries, CROs and bio-pharma small-medium enterprises.

Support in scouting and application to funding opportunities

This centralised service is provided as “expert support” to identify possible grants opportunities in research areas related to EPTRI activities as well as provide support in designing, organising and applying for funding.

Suitable funding opportunities will be searched to provide reports of suitable funds in the users’ field of interest.

Research project management

The service provides support in managing funded research projects. According to European Commission (EC)’ rules, acting as the reference of the service, the following activities are intended to be provided within this service:

– Implementation of consistent project management processes, tools and templates to successfully meet EC or other sponsors’ requirements to deal with timing and available funds

– Assure day-by-day supervision and management of the project

– Managing all contractual and other legal issues related to the project

– Define KPIs and measures performance during the activities

– Develop a chart of risks and remediation measures.

Advice on the design and requirements of non-clinical specific studies/experiments

The service provides advice on issues that researchers can encounter while they prepare experimental protocols, define a plan to complete preclinical studies phases or need to solve regulatory aspects with reference to studies.

It will be in terms of:

– Consultancy on technical design of not clinical experiments in a plan of development for specific studies

– Consultancy on innovation pathway for specific products (paediatric developmental plans)

– Consultancy on Preparation of Regulatory applications and reply to queries from the Regulatory Agencies with reference to paediatric preclinical, safety, or pharmaceutical studies to be part of a paediatric medicine developmental plan

– Consultancy on Exploitation and Intellectual Property Rights (IPR) valorisation.

Advice on translation to clinical phases

EPTRI can contribute to underpin paediatric clinical research with:

1. the paediatric specific clinical studies design;

2. the adoption of innovative methodologies, extrapolation, modelling and simulation, to reduce the need for clinical studies;

3. mediating collaborations with clinical resources, paediatric clinical trial networks, ERNs and research initiatives.