Welcome to the website of EUCROF, the European CRO Federation.
EUCROF was founded in October 2005.
The aims and objectives of EUCROF were defined as follows:
- Promote clinical research of high quality in Europe in general and in the European Union in particular;
- Form a legal entity 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;
- Promote a close relationship and mutual understanding between the national member associations and the above-mentioned bodies;
- Promote the exchange of information between member associations;
- Develop training and educational programmes for clinical research, and assist the national member associations in setting up such programmes and ensuring their quality;
- Distribute information on developments in clinical research to health professionals;
- Organise international conferences and meetings.
Furthermore, the Federation's objectives include: discussions on selected topics with representatives of the pharmaceutical industry e.g. PCMG (Pharmaceutical Contract Management Group) to enhance business relations and identify common concerns, support more productive discussions with European bodies (EMEA/EU Commission), and endeavour to develop transcontinental relationships with other associations e.g. with ACRO in the USA and JCROA in Japan.
The Federation consists of members from 12 EU countries: Belgium (BeCRO), Czech Republic (ACRO-CZ), France (AFCROs), Germany (BVMA), Greece (HACRO), Italy (AICRO), Slovakia (SACROP), Spain (AECIC), Sweden (ASCRO), the Netherlands (ACRON), Turkey (SAKDER) and UK (CCRA). The Federation has also 8 associate members in Austria, Bulgaria, Denmark, Germany, Portugal, Switzerland, UK and Ukraine. It stands for 326 member CROs and over 20,000 employees.
Since December 2006, the Federation is managed by an Executive Board (see here below) which holds monthly meetings. Each year, the Federation organizes two General Meetings (March & November) with all its members.
EUCROF has created 10 working groups:
- Clinical Trials Legislation: this group focuses on any proposed changes to Regulations and Guidelines for Clinical Trials - predominantly in the EU, but not only. This group actively participates in consultations and prepares comments for feedback to the EMA and other regulators.
- Communication: this group is focused on the effective and timely communication to EUCROF’s members and stakeholders of all of the Federation’s initiatives, activities and important news to facilitate increased awareness and the achievement of its set objectives.
- Early Phase Clinical Study: this group evaluates and compares current practices within the bio-equivalence studies and the Phase I studies in Europe;
- Education and Training: this group establishes educational webinars throughout the year for its members and wider audience to provide training and increased awareness of key topics in clinical research.
- Late Phase: this group promotes good practices in the conduct of Late Phase studies in Europe - with particular reference to observational ones - through the sharing of knowledge, competence, expertise and skills, also speaking in congresses/conferences and participating EMEA public consultations.
- Medical Device: this provides a forum for discussion of various aspects of clinical research associated with Medical Devices and IVD. Its further objective is to interact and share experiences with other stakeholders involved in this area.
- New Technologies: this group evaluates current and expected new technologies and evaluates how these can benefit and impact the clinical trial environment.
- Outsourcing Management: this group looks to address the challenges and opportunities faced by the CROs in their collaborations with industry promoting best practices.
- Paediatric: this group works closely with authorities, paediatric networks, and associations such as EFGCP to improve paediatric research. The group collects and analyses information on paediatric research that it shares via trainings, publications, presentations at conferences. The group participates in initiatives set up to improve research in children and to develop better medicines for children.
- Pharmacovigilance: this group focuses on management of pharmacovigilance services throughout the product lifecycle which are increasingly undertaken by the CRO sector for the industry, including current and future best practices as well as regulations for this critical area.
EUCROF is now "recognized" by European Authorities:
- EUCROF has been integrally involved in stakeholder meetings with the EMA to discuss the implementation of the forthcoming EU Clinical Trials Regulation. Over the last 2 years EUCROF has been able to work with other stakeholder groups to influence and shape important aspects of the planned implementation, in particular the transparency requirements of the new Regulation. These meetings will continue until at least the planned implementation of the Regulation in October 2018.
- EUCROF was invited by the EMA to participate in the User Acceptance Testing (UAT) of the clinical trial portal and database and contribute to its on-going development. So far over 50 EUCROF testers have been involved in 4 UATs during 2016 with more follow in 2017.
- EUCROF has participated in the EMEA Workshop on Guideline for first-in-man clinical trials for potential high-risk medicinal products in June 2007;
- EUCROF has been invited to participate in a European Commission - EMEA Conference on the Operation of the Clinical Trials Directive (Directive 2001/20/EC) and Perspectives for the Future in October 2007;
- EUCROF has met Mr Fergus Sweeney, Principal Scientific Administrator Inspections Sector, in July 2008. The objective of this meeting was to establish a permanent working relationship;
- EUCROF is now a well-known and recognized European representative for CROs giving them a voice in the EU.
- President, Martine DEHLINGER-KREMER (Germany)
- Vice-President, Stefano MARINI (Italy)
- Treasurer, Yoani MATSAKIS (France)
- Secretary, Simon LEE (UK)
- Member, Christophe GOLENVAUX (Belgium)
EUCROF Secretariat :
Assia Rosati- EUCROF - Via Bassano del Grappa, 4 - 00195 Rome (Italy)