c4c - conect4children (COllaborative Network for European Clinical Trials For Children) / Edukad projektid

coordinating country [ IT ] search term [ Glaxosmithkline Research and Development LTD ]

conect4children (COllaborative Network for European Clinical Trials For Children)

acronym:	c4c
start:	2018-05-01
end:	2024-04-30

programme:	H2020 - Horisont 2020
sub-programme:	HEALTH - Tervishoid, demograafilised muutused ja heaolu
instrument:	JTI-IMI2-RIA
call identifier:	H2020-JTI-IMI2-2016-10-two-stage
project number:	777389
duration in months:	72
partner count:	47

abstract:	Paediatric medicines development is embedded in the European policy, legislation and in the work of the pharmaceutical industry but currently the potential of this effort is not realised. The conect4children (c4c) project will address the critical problems with the design, implementation and operational conduct of paediatric clinical trials, for example the fragmented and redundant efforts between sponsors, sites and countries. This project will generate a sustainable infrastructure that optimises the delivery of clinical trials in children through: a) a single point of contact for all sponsors, sites and investigators; b) efficient implementation of trials adopting consistent approaches, aligned quality standards and coordination of sites at national and international level; c) collaboration with specialist networks; d) high quality input to study design and preparation through rigorous strategic and operational feasibility assessment and e) the promotion of innovative methodologies. The project will be managed according to IMI2 best practice with a dedicated communications effort. The clinical trials infrastructure will be setup, implemented and tested by implementing 3-4 industry and at least 1 non-industry proof-of-viability studies. Expert advice groups will promote innovative methodologies and engagement with regulators. The business model for a sustainable infrastructure will be based on the European landscape of paediatric networks and available trial sites, the evaluation of services needs of sponsors of all kinds, and will be informed by the proof-of-viability studies. Supporting activities will include: data management (data about the trials and the network, including performance metrics for network management and promotion; handling trial data for non-industry sponsors; support for common data dictionaries); education and training. The voices of children, young people and their families will be central to the network.

partner no and role		partner name	country	contact person	web page
1	coordinator	FONDAZIONE PENTA - FOR THE TREATMENT AND CARE OF CHILDREN WITH HIV ANDRELATED DISEASES - ONLUS	IT	Carlo GIAQUINTO	www.penta-id.org
2	partner	THE UNIVERSITY OF LIVERPOOL	UK		www.liverpool.ac.uk
3	partner	OSPEDALE PEDIATRICO BAMBINO GESU	IT		www.ospedalebambinogesu.it
4	partner	EURORDIS - EUROPEAN ORGANISATION FOR RARE DISEASES ASSOCIATION	FR		www.eurordis.org
5	partner	EUROPEAN CYSTIC FIBROSIS SOCIETY	DK		www.ecfs.eu
6	partner	STICHTING KATHOLIEKE UNIVERSITEIT	NL		www.ru.nl
7	partner	SWISS CLINICAL TRIAL ORGANISATION	CH		www.scto.ch
8	partner	Associação para Investigação e Desenvolvimento da Faculdade de Medicina	PT
9	partner	ISTITUTO GIANNINA GASLINI	IT		http://www.gaslini.org
10	partner	UNIVERSITY COLLEGE LONDON	UK		http://www.ucl.ac.uk
11	partner	SIOP EUROPE ASBL	BE		www.siope.eu
12	partner	Tartu Ülikool	EE		http://www.ut.ee
13	partner	OKIDS GMBH	AT		www.okids-net.at
14	partner	UNIVERSITY OF NEWCASTLE UPON TYNE	UK		www.newcastle.ac.uk
15	partner	UNIVERSITEIT GENT	BE		http://www.ugent.be
16	partner	UNIVERSITATSKLINIKUM HEIDELBERG	DE
17	partner	ARISTOTELIO PANEPISTIMIO THESSALONIKIS	EL		www.auth.gr
18	partner	INSTYTUT POMNIK CENTRUM ZDROWIA DZIECKA	PL		www.czd.pl
19	partner	HELSE BERGEN HF*HAUKELAND UNIVERSITY HOSPITAL	NO		http://www.helse-bergen.no/
20	partner	ECNP RESEARCH AND SCHOLARSHIP STICHTING (DE ECNP RESEARCH AND SCHOLARSHIP FOUNDATION)	NL		www.ecnp.eu
21	partner	ROBERT BOSCH GESELLSCHAFT FUR MEDIZINISCHE FORSCHUNG MBH	DE
22	partner	UNIVERSITY COLLEGE CORK - NATIONAL UNIVERSITY OF IRELAND, CORK	IE		www.ucc.ie
23	partner	KAROLINSKA INSTITUTET	SE		www.ki.se
24	partner	FUNDACIO SANT JOAN DE DEU	ES		www.fsjd.org
25	partner	SERVIZO GALEGO DE SAUDE	ES		www.sergas.es
26	partner	GYERMEKGYOGYASZATI KLINIKAI VIZSGALOI HALOZAT	HU		www.mcrn.hu
27	partner	FONDAZIONE PER LA RICERCA FARMACOLOGICA GIANNI BENZI ONLUS	IT		www.benzifoundation.org
28	partner	ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK	FR		www.ecrin.org
29	partner	HELSINGIN JA UUDENMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMÄ	FI		www.hus.fi
30	partner	INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE	FR		www.inserm.fr
31	partner	HELIOS DR. HORST SCHMIDT KLINIKEN WIESBADEN GMBH	DE
32	partner	ARSENAL.IT - CENTRO VENETO RICERCAE INNOVAZIONE PER LA SANITA DIGITALE	IT		www.consorzioarsenal.it
33	partner	UNIVERZITA KARLOVA	CZ		www.cuni.cz
34	partner	JANSSEN PHARMACEUTICA NV	BE		http://www.janssen.com/
35	partner	BAYER AKTIENGESELLSCHAFT	DE		bayer.de
36	partner	SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT	FR		sanofi-aventis.com
37	partner	Eli Lilly and Company Limited	UK
38	partner	UCB BIOPHARMA SPRL	BE		www.ucb.com
39	partner	NOVARTIS PHARMA AG	CH
40	partner	INSTITUT DE RECHERCHES INTERNATIONALES SERVIER	FR		http://www.servier.fr
41	partner	GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD.	UK		www.gsk.com
42	partner	PFIZER LIMITED	UK		www.pfizer.com
43	partner	F. HOFFMANN-LA ROCHE AG	CH		www.roche.com