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PedCRIN SIGNED

Paediatric Clinical Research Infrastructure Network

Total Cost €

EC-Contrib. €

Partnership

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Outcomes and
results

PedCRIN project word cloud

Explore the words cloud of the PedCRIN project. It provides you a very rough idea of what is the project "PedCRIN" about.

empowerment wp3 strategies ing sponsored group quality wp2 ecrin few packages disease area landmarks reporting pilot world age conducting attracting neonatal monitoring capacity wp5 ethical multinational methodology safety trials opportunity uncritical establishment plan infants transnational efficacy suggested societal bio treatments countries adverse extrapolation certification adult org updated event parents patient cooperation scientific tested wp1 communication esfri eatris competences government policymakers database builds demonstrating requiring governance clinical model data strategy communities financial tools jointly children had roadmap sustainability bbmri health observer pedcrin business industry eric board 2016 organisation outcome upgrade wp4 paediatric epctri medicines trial regulatory infrastructure

Project "PedCRIN" data sheet

The following table provides information about the project.

Coordinator	ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK Organization address address: 5 RUE WATT city: PARIS postcode: 75013 website: www.ecrin.org contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.
Coordinator Country	France [FR]
Project website	http://www.pedcrin.org
Total cost	3˙296˙000 €
EC max contribution	3˙296˙000 € (100%)
Programme	1. H2020-EU.1.4.1.1. (Developing new world-class research infrastructures)
Code Call	H2020-INFRADEV-2016-1
Funding Scheme	CSA
Starting year	2017
Duration (year-month-day)	from 2017-01-01 to 2020-12-31

Partnership

Take a look of project's partnership.

#	participants	country	role	EC contrib. [€]
1	ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK Organization address address: 5 RUE WATT city: PARIS postcode: 75013 website: www.ecrin.org contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	coordinator	1˙560˙125.00
2	THE UNIVERSITY OF LIVERPOOL THE UNIVERSITY OF LIVERPOOL Organization address address: BROWNLOW HILL 765 FOUNDATION BUILDING city: LIVERPOOL postcode: L69 7ZX website: www.liverpool.ac.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (LIVERPOOL)	participant	325˙875.00
3	VERENIGING SAMENWERKENDE OUDER- EN PATIENTENORGANISATIES VERENIGING SAMENWERKENDE OUDER- EN PATIENTENORGANISATIES Organization address address: Vredehofstraat 31 city: SOEST postcode: 3761HA website: www.vsop.nl contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (SOEST)	participant	185˙625.00
4	FUNDACIO SANT JOAN DE DEU FUNDACIO SANT JOAN DE DEU Organization address address: Calle Santa Rosa, 39-57 city: Esplugues de Llobregat postcode: 8950 website: www.fsjd.org contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ES (Esplugues de Llobregat)	participant	178˙125.00
5	HELSINGIN JA UUDENMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMÄ HELSINGIN JA UUDENMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMÄ Organization address address: STENBACKINKATU 9 city: HELSINKI postcode: 29 website: www.hus.fi contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FI (HELSINKI)	participant	178˙125.00
6	INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE Organization address address: RUE DE TOLBIAC 101 city: PARIS postcode: 75654 website: www.inserm.fr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	participant	178˙125.00
7	STICHTING KATHOLIEKE UNIVERSITEIT STICHTING KATHOLIEKE UNIVERSITEIT Organization address address: GEERT GROOTEPLEIN NOORD 9 city: NIJMEGEN postcode: 6525 EZ website: www.radboudumc.nl contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (NIJMEGEN)	participant	178˙125.00
8	CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE Organization address address: VIA NICOLO PUTIGNANI 178 city: BARI postcode: 70122 website: www.cvbf.net contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (BARI)	participant	170˙625.00
9	ARISTOTELIO PANEPISTIMIO THESSALONIKIS ARISTOTELIO PANEPISTIMIO THESSALONIKIS Organization address address: KEDEA BUILDING, TRITIS SEPTEMVRIOU, ARISTOTLE UNIV CAMPUS city: THESSALONIKI postcode: 54636 website: www.auth.gr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	EL (THESSALONIKI)	participant	48˙750.00
10	HELSE BERGEN HFHAUKELAND UNIVERSITY HOSPITAL HELSE BERGEN HFHAUKELAND UNIVERSITY HOSPITAL Organization address address: JONAS LIES VEI 65 city: BERGEN postcode: 5021 website: http://www.helse-bergen.no/ contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NO (BERGEN)	participant	48˙750.00
11	KAROLINSKA INSTITUTET KAROLINSKA INSTITUTET Organization address address: Nobels Vag 5 city: STOCKHOLM postcode: 17177 website: www.ki.se contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	SE (STOCKHOLM)	participant	48˙750.00
12	OKIDS GMBH OKIDS GMBH Organization address address: ZIMMERMANNPLATZ 10 city: WIEN postcode: 1090 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	AT (WIEN)	participant	48˙750.00
13	SWISS CLINICAL TRIAL ORGANISATION SWISS CLINICAL TRIAL ORGANISATION Organization address address: EFFINGERSTRASSE 35 city: BERN postcode: 3008 website: www.scto.ch contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	CH (BERN)	participant	48˙750.00
14	TARTU ULIKOOL TARTU ULIKOOL Organization address address: ULIKOOLI 18 city: TARTU postcode: 51005 website: www.ut.ee contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	EE (TARTU)	participant	48˙750.00
15	THE NATIONAL CHILDREN'S RESEARCH CENTRE THE NATIONAL CHILDREN'S RESEARCH CENTRE Organization address address: OUR LADY'S CHILDREN'S HOSPITAL CRUMLIN city: DUBLIN postcode: DUBLIN 12 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IE (DUBLIN)	participant	48˙750.00

Map

Project objective

Children’s health is a major societal challenge for Europe and the world, requiring development of paediatric medicines and treatments strategies based on evidence derived from clinical trials demonstrating efficacy and safety in infants and children, rather than on uncritical extrapolation from adult data (over 50 % of the medicines used for children had not been tested in this specific age group).

Conducting clinical trials in children requires specific competences and infrastructure. ECRIN-ERIC (www.ecrin.org) is a generic infrastructure for multinational trial management, in any disease area. However it does not specifically address the paediatric needs in terms of trial management capacity. In its 2016 Roadmap, ESFRI suggested an upgrade of ECRIN to develop a common infrastructure for paediatric trial management through cooperation with the European Paediatric Clinical Trial Research Infrastructure (EPCTRI). The resulting PedCRIN project is also a unique opportunity to improve ECRIN business model and financial sustainability, attracting more industry-sponsored trials and more Member and Observer countries.

PedCRIN builds on five work packages : project coordination (WP1); establishment of a strategy and upgrade of the governance and business plan, through a Sustainability Board jointly involving the scientific partners and the government representatives (WP2); development of tools specific for paediatric and neonatal trials (WP3) (methodology, outcome measures, adverse event reporting, bio-sample management, ethical and regulatory database, monitoring, quality and certification); operational support provided as transnational access to a few pilot trials to test the updated organisation and tools (WP4); communication targeting user’s communities (including industry), policymakers, patient and parents’ empowerment (WP5). Two other ESFRI-landmarks, BBMRI-ERIC and EATRIS ERIC, will contribute to PedCRIN.

Deliverables

List of deliverables.
Project newsletters 5	Documents, reports	2020-02-27 11:41:24
Project newsletters 4	Documents, reports	2020-02-27 11:41:24
Procedure for access to individual patient clinical trial data	Documents, reports	2020-02-27 11:41:23
Advisory Board report 1	Documents, reports	2020-02-27 11:41:23
Composition of Scientific Board	Documents, reports	2020-02-27 11:41:23
Cost evaluation for the selected trials	Documents, reports	2020-02-27 11:41:23
Project newsletters 2	Documents, reports	2020-02-27 11:41:23
Communication and Dissemination Plan	Documents, reports	2020-02-27 11:41:23
Press releases and factsheet	Documents, reports	2020-02-27 11:41:24
Specification of the call	Websites, patent fillings, videos etc.	2020-02-27 11:41:23
Gap analysis based on survey data	Documents, reports	2020-02-27 11:41:23
Logo and Brochure	Documents, reports	2020-02-27 11:41:23
Interim report	Documents, reports	2020-02-27 11:41:23
Criteria for projects selection	Documents, reports	2020-02-27 11:41:23
Report on patient engagement and perspective integration	Documents, reports	2020-02-27 11:41:24
Procedure for patient level data sharing	Open Research Data Pilot	2020-02-27 11:41:23
Survey on infrastructure and service needs for paediatric and neonatal trials	Websites, patent fillings, videos etc.	2020-02-27 11:41:22
Project newsletters 3	Documents, reports	2020-02-27 11:41:24
Project newsletters 1	Documents, reports	2020-02-27 11:41:23
Project Website	Websites, patent fillings, videos etc.	2020-02-27 11:41:23
Advisory Board report 2	Documents, reports	2020-02-27 11:41:24

Take a look to the deliverables list in detail: detailed list of PedCRIN deliverables.

Publications

List of publications.
year	authors and title	journal	last update
2019	Eric Vermeulen, Kim Karsenberg, Johanna H. Lee, Saskia N. Wildt Involve Children and Parents in Clinical Studies published pages: 11-13, ISSN: 1752-8054, DOI: 10.1111/cts.12696	Clinical and Translational Science 13/1	2020-03-05

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The information about "PEDCRIN" are provided by the European Opendata Portal: CORDIS opendata.