EUCROF Quality Mark Concept for Early Phase Units Initiative - First Pilot Audit Performed

ROME, Dec. 20, 2013 /CNW/- The European CROs Federation (EUCROF) today provided an update on the status of the federation's Quality Mark Concept of Early Phase Units initiative.

"We are pleased to provide this update on our activities in this regard," noted Stefano Marini MD, EUCROF President. "We hope that industry stakeholders will find this information of interest and of direct relevance to their work in early phase clinical development."

"Development of the Early Phase Unit Quality Mark Concept began in late 2012 resulting in a first pilot audit which occurred in November 2013 as part of the development and evaluation process," explained Philippe Van Der Hofstadt, Co-chair of EUCROF Early Phase Working Group. "The Quality Mark Concept will be supported by a code of conduct, criteria list for auditing, template for report and certificate. Finalization and publication of the full details of the scheme is planned to take place in the second quarter of 2014, with the expectation that participation in the scheme will be made available to European Early Phase Units or to those which are following the European regulatory framework. We look forward to providing further information in due course."

About the European CROs Federation (EUCROF): EUCROF was founded in October 2005 with the aim of promoting high quality clinical research in Europe in general and in the European Union in particular, and now has member organizations from 11 European countries. EUCROF also seeks to represent the interests of CROs in the EU, for example, in transactions with regulatory bodies, the pharmaceutical-biotechnology industry and the medical research community. Additionally, EUCROF seeks to promote a close relationship and mutual understanding between the national member associations and the above-mentioned bodies.


For further information: Stefano Marini, EUCROF President, Phone: +39(0)6-807-60-72, Fax: +39(0)6-807-60-85; c/o Paola Portera, EUCROF, 12, viale Parioli, 00197 Rome - Italy,

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