Corporate Members Directory

SILVER Corporate Members

As a leading human therapeutics company in the biotechnology industry, Amgen is pleased to support the EFGCP to promote good clinical practice and high quality biomedical research. For almost 30 years, we have tapped the power of scientific discovery and innovation to advance the practice of medicine. We know that strong relationships are critical to our ability to best serve patients, and they are built upon ethical and responsible business conduct and reliable disclosure of information. As part of our commitment to conducting research that meets only the highest ethical standards, Amgen has many policies and principles which govern our clinical practices from sponsorship to scientific exchange (all of which are published on our website www.amgen.com under ‘Clearly Amgen’). To guide our clinical research efforts we have developed the Global Code of ethics for Clinical Trials, with particular attention to protecting the rights, dignity and safety of research participants worldwide. This Code draws from well accepted standards for clinical research, including those published under International Conference on Harmonization (ICH). To that end, all Amgen sponsored trials are designed and conducted to the same high standards that meet or exceed all applicable local laws as well as widely accepted international regulatory standards. www.amgen.com

At GlaxoSmithKline (GSK) high ethical standards in R&D are key to protecting participants in our clinical research, ensuring the quality of our research, and maximising the benefits and minimising the risks of our medicines and vaccines. High ethical standards are also essential for us to obtain regulatory approval for new medicines, and for patients and doctors to put their trust in our research programmes and products. Our R&D policies are global and we apply the same high research standards wherever we operate, including for research conducted by contract organisations on our behalf. We have rigorous procedures and assurance processes to ensure clinical trials of our medicines are conducted according to the Good Clinical Practice (GCP) guidelines . GSK is committed to focusing on the patient in everything that we do and our R&D pipeline is central to our ability to meet patients' needs. We are committed to being open about the results of our clinical research and use a number of reporting channels so that those who evaluate the efficacy and safety of our medicines or use our medicines can make informed decisions on their use. As part of our commitment to understand patient needs, and to develop better medicines, we have a programme of activities where we invite patients to discuss their conditions with our research teams. We recognise that biomedical research can raise ethical concerns and refer to guidance from national and international groups to inform our research activities. GSK is pleased therefore to support EFGCP in its purpose to promote good clinical practice and encourage the practice of common, high-quality standards in all stages of biomedical research. www.gsk.com

It is Pfizer policy to sponsor, throughout the world, only high quality clinical research that follows accepted ethical, scientific, and clinical standards. Specifically, Pfizer takes measures to ensure that all its sponsored clinical studies are conducted in accordance with local laws and regulations, as well as relevant international standards such as the International Conference of Harmonization (ICH) Good Clinical Practices (GCP) Guidelines. Pfizer recognizes that social and cultural considerations and needs in countries that lack adequate human subject protection infrastructure or laws may necessitate the implementation of additional measures to ensure appropriate protection and respect for the rights of study participants in the conduct of clinical studies in those countries. In consideration of these commitments, Pfizer is pleased to support the activities of the EFGCP to promote good clinical practice and encourage the practice of common, high-quality standards in all stages of biomedical research throughout Europe. www.pfizer.com

BRONZE Corporate Members

Crossover CRI AG (Crossover) was established in 2007 in Switzerland to develop clinical research infrastructures with Crossover professional staff and equipment at research- driven healthcare institutions. Our Clinical Research Units are embedded at hospitals, where we manage the clinical trials portfolio in very close collaboration with Investigators and the Hospital day in, day out. Clinical trials are at the core of evidence-based medicine. We support the EFGCP as a place where all stakeholders involved in clinical trials discuss how best to conduct clinical trials. www.crossover-cri.com

medac is a privately held pharmaceutical company with a focus in oncology and autoimmune diseases. We develop new products as well as improvements of registered drugs in order to facilitate the daily life of patients. Our aim is to conduct studies that are based on good science, are well designed and properly analysed, to make sure that the rights and the wellbeing of the patients is taken care of and that study procedures are properly undertaken and documented. This is done in accordance with local laws and regulations as well as with GCP and ICH guidelines and the Declaration of Helsinki.Very early we realized that special populations require special attention which should be kept in mind when deciding on trial designs. medac is pleased to support EF GCP in its aim to promote good clinical practice and high quality standars in biomedical research. www.medac.de

Merck Serono is the division for innovative prescription pharmaceuticals of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical company. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. Merck Serono and its worldwide affiliates carry out a series of clinical trials approved by regulatory and ethics committees, to evaluate each investigational drug to determine how it acts and whether it is safe and effective in the target human population. In addition, we continue to evaluate our medicines and medical devices in clinical trials after we have received regulatory approval to market the products. Our clinical trials are conducted to the highest medical and ethical standards, in accordance with the ethical principles laid down in the Declaration of Helsinki, and that are consistent with Good Clinical Practice and applicable regulations. To this end, Merck Serono is pleased to support the EFGCP in its efforts to encourage the practice of common, high-quality standards in all stages of biomedical research. www.merckserono.com

Synergy Research Group (SynRG™) is a leading Russian Contract Research Organization (CRO) successfully assisting pharmaceutical and biotechnology companies, as well as global CROs in conducting clinical trials in Russia and the Commonwealth of Independent States (CIS) since 2002. SynRG was established as an answer to the growing demand for clinical trials in CEE, and Russia and CIS, in particular. We are committed to provide high quality services capitalizing on our in-depth knowledge of international and local regulations, long-term relationships with central and peripheral medical institutions, and a broad network of investigators with vast clinical research experience in various therapeutic areas. SynRG’s core values are those of the Russian Troika: Speed, Cost, and Quality. SynRG’s Goal is to shorten time to market for Sponsor’s drugs by providing the speedy patient recruitment and high data quality at reasonable costs using our strong Russian expertise, in-depth GCP knowledge and solid local presence. We achieve this goal by maintaining business relationships built on a thorough understanding of our clients’ needs and requirements, by creating true partnership with the clients, and by sharing strong commitment to excellence. Everyone at SynRG shares the same strong commitment to excellence. SynRG’s Mission is to improve people’s lives by helping our clients develop new safe and effective products to fight disease. That’s why we are with EFGCP… www.synrg-pharm.com