The EUCROF Association

Welcome to the website of EUCROF

 

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 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 (Association of Clinical Research Organisations) in the USA and JCROA (Japanese Clinical Research Organization) 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), Romania (ACCSCR), Slovakia (SACROP), Spain (AECIC), The Netherlands (ACRON), Turkey (SAKDER) and UK (CCRA). The Federation has also 14 Associate Members in Albania, Austria, Bulgaria, Croatia, Denmark, Georgia, Serbia, Spain, Sweden, Switzerland (2), Ukraine and UK (2), as well as two Parner Members in Algeria and Israel. It stands for 360 member-CROs and represents 24 countries.

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 (in Spring and Fall) with all its Association Members, Associate Members and Partner Members.

 

Definition of CRO: “A Contract Research Organisation (also called Clinical Research Organisation, CRO), is a person or an organisation (including commercial, academic and non-profit)  that provides services to industry and other stakeholders such as governmental organisations, foundations or hospitals, on a contract basis and within the scope of clinical research (experimental or observational), as well as other activities in connected domains.” 

 

EUCROF has 12 Working Groups:

  1. Clinical Trial Centres: this WG was created at the beginning of 2020. The primary objective of the Clinical Trial Centres Working Group is to look for synergies between CROs and Research Sites / Clinical Trial Centres to enforce and guarantee the clinical research in Europe. It is indispensable to ensure that sites are well-prepared and within the Working Group definitions; expectations can be set, which can be of support for both CROs and Clinical Trial Centres. Through the Working Group it is also possible to represent Clinical Trial Centres and be a partner of the dialogue with European Authorities, Associations, the pharmaceutical industry and medical device representative organisations. 
  2. Clinical Trials Legislation: This group focuses on any proposed changes to Regulations and Guidelines for Clinical Trials - predominantly in the EU, but also elsewhere in the world. This group actively participates public in consultations and prepares comments for feedback to the European Medicines Agency (EMA) and other regulators.
  3. 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.
  4. Early Phase: This group evaluates and compares current practices within the bio-equivalence studies and the Phase I studies in Europe;
  5. Events & 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.
  6. Innovative Medicine: This group is focused on Advanced Therapies Medicinal Products. The goal of this group is to identify, examine and provide solutions to the principal issues identified in ATMPs development and regulation, in constant dialogue and collaboration with the Industry and European Authorities.
  7. Real World Data & Digital Health: 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 EMA public consultations.
  8. Medical Devices: This group 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.
  9. New Technologies: this group evaluates current and expected new technologies and evaluates how these can benefit and impact the clinical trial environment.
  10. Patients' Association: This group fosters actual and confident collaboration with patients in clinical research.
  11. 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.
  12. Pharmacovigilance: This group focuses on management of pharmacovigilance services throughout the product lifecycle which are increasingly undertaken by the CRO sector for the pharma & biotech industry, including current and future best practices, as well as regulations for this critical area.

 

EUCROF is a stakeholder of European Regulatory Authorities:

EUCROF has been integrally involved in stakeholder meetings collaborating with the EMA to discuss and support the implementation of the forthcoming EU Clinical Trials Regulation. Since 2014 EUCROF has been able to work with other stakeholders to influence and shape important aspects of the planned implementation, in particular the transparency requirements of the new Regulation some years ago and in more recent years the Clinical Trial Information System. Stakeholder meetings routinely occur 3 to 4 times a year and are either face to face at the EMA’s offices in Amsterdam or via Webex and it is anticipated they will continue until at least the planned implementation of the Regulation.

EUCROF participated from the start of the development of the clinical trial portal and database (now called the Clinical Trial Information System) and was involved in the initial User Acceptance Testing (UAT) of the system. During the initial development, over fifty EUCROF testers were involved in 6 UATs during 2016, 2017 and 2018. However, in 2019 the EMA switched to a new approach progress this important project. This new approach involves an iterative and more agile project delivery model such that the project will develop and deliver functionalities through short-cycled sprints that require planning of the scope, analysis, design, development and delivery. Due to its contributions to date EUCROF was selected to have 2 Product Owners (POs) participate in the important testing activities with POs from other stakeholders’ associations.

A press release from the EMA covering its Management Board meeting in December 2019, which confirmed the Board’s agreement of an updated plan outlining the items that needed to be completed ahead of the audit of the CTIS to commence by December 2020. EUCROF POs are continuing to provide support throughout 2020 ahead of this audit.

In addition, EUCROF interacts with the EMA and contributes to several of its other initiatives. This includes providing comments on EMA Consultation papers and attending meetings and workshops. Our most recent examples are as follows:

  • EMA Guidance Consultation

Our Clinical Trial Legislation Working Group, chaired by Dagmar Chase, has collaborated with EFPIA and other organisations to review a document issued by the EMA entitled

Submission of comments on 'Point to consider on implications of Coronavirus diseases (COVID-19) on methodological aspects of ongoing clinical trials' (EMA/158330/2020)

There was a four-week public consultation, until 23 April 2020, after which a consolidated response from all parties was submitted to the EMA. There was a large number of comments submitted, which confirmed the very high level of interest and need for guidance regarding the implications of COVID-19 on methodological aspects of ongoing clinical trials.

In addition, EUCROF’s President, Martine Dehlinger-Kremer, along with input from some members, provided input to EU Commission/EMA for the revision of the Guidance (v3) for sponsors on how to manage clinical trial during the COVID-19 pandemic

Feedback on two key issues identified for temporary regulatory flexibility:

  • direct sponsor/distributor to patient IMP transfer
  • remote source data verification as to not hinder market access of COVID-19 treatment or life-saving medicines for unmet medical needs. 
  • EMA’s Regulatory Science Strategy.

The EMA published its strategy in March 2020. It provides a plan for advancing regulatory science over the next five years, covering both human and veterinary medicines. It comes in response to the dramatic acceleration of the pace of innovation in recent years and the need for regulators to be ready to support the development of increasingly complex human and veterinary medicines, that combine different technologies. The ongoing COVID-19 pandemic underlines the need for rapid and close engagement of all stakeholders and partners involved in the development and supervision of medicines in the European Union and globally, which is one of the fundamental principles of this strategy. The learnings from the handling of this public health crisis will be incorporated, so that we can adapt our process in real-time, where needed.

The strategy sets out key areas where new or enhanced engagement of the European medicines regulatory network is essential and where advances in regulatory science are necessary.

The document identifies strategic goals for such engagement for human and veterinary medicines and proposes core recommendations and underlying actions to support these.

EUCROF’s President, Dr Martine Dehlinger-Kremer, attended two workshops to discuss and contribute to the draft strategy prior to its publication.

The above confirms how EUCROF has established itself as a well known and highly recognised representative for CROs, giving them a voice in the EU.

 

Executive Board

  • President, Martine DEHLINGER-KREMER (Germany)
  • Vice-President, Stefano MARINI (Italy)
  • Secretary, Simon LEE (UK)
  • Treasurer, Yoani MATSAKIS (France)
  • Member, Christophe GOLENVAUX (Belgium)

 

EUCROF Secretariat

Assia Rosati - EUCROF

Mobile: +39 349 858 6648

Email: This email address is being protected from spambots. You need JavaScript enabled to view it. - website: http://www.eucrof.eu

  

The Executive Board

Dr Martine Dehlinger-Kremer

 President

German Federal Association of Contract Research Organisations (BVMA)
Germany

Stefano Marini

Vice-President

Associazione Italiana Contract Research Organization (AICRO)
Italy

Yoani Matsakis

Treasurer

Association Française des CROs (AFCROs)
France

Simon Lee

 Secretary

Clinical and Contract Research Association (CCRA)
United Kingdom

Christophe Golenvaux

Member

The Belgian Association of CROs (BeCRO)
Belgium

Mission Statement

The objective of EUCROF (the European CRO Federation), a non-profit organization founded in 2005, is to promote Clinical Research by improving the knowledge, competence/expertise and skills of Contract/Clinical Research Organisations (CROs) in Europe.

The Federation represents and supports the interests of CROs in Europe towards regulatory bodies, the pharmaceutical, biotech, medical device and other healthcare-related industry within the field of clinical research, as well as the medical and affiliated research community. EUCROF organises and supports training and education programs to increase the quality of clinical research and to improve collaboration and interaction amongst all stakeholders in the field of Clinical Research in Europe. Active participation in international congresses and meetings further underlines the significant role of CROs in Clinical Research in Europe.

Regulatory Authorities recognize EUCROF as the representative for European-based CROs, regularly calling upon EUCROF to contribute to the never-ending debate on the improvement of rules and regulations.