December 12, 2011 -- Premier Research Group Limited announces that Nicky Dodsworth, Premier Research’s Vice President of Global Quality Assurance, has been appointed the New Chair of the Education Working Party for the European Forum for Good Clinical Practice (EFGCP). The EFGCP Education Working Party aims at promoting education among groups involved in clinical research. This includes education for investigators, monitors and members of Ethics Committees, in different aspects of GCP with the aim of providing coordinated and harmonized educational and training programs across Europe.
Founded in 1993 during a conference at the European Parliament with the support of the European Commission, EFGCP’s purpose is to promote GCP and encourage the practice of common, high-quality standards in all stages of biomedical research throughout Europe and globally. Since its creation, EFGCP, a non-profict organization, has functioned as a leading European think tank for discussion, research, and critical evaluation in the development of European health research.
Nicky Dodsworth joined Premier Research in March 2008 and currently heads up the Global Quality Assurance group. Nicky’s experience includes more than 25 years in clinical research focusing on quality and training with experience across most geographical locations. Her experience ranges across all phases of clinical trials in many therapeutic areas. Nicky has been actively involved in developing quality systems and has written numerous standard operating procedures (SOPs), including a system for ISO 9001 accreditation. She has also audited extensively across Western and Eastern Europe, Russia, North and South America, Africa and Asia. Nicky has conducted extensive training of various groups throughout her working life which requires her to have the subject matter expertise as well as communication, motivation and personal qualities. She regularly presents at key conferences and has presented or run training courses in 14 different countries.
Nicky has been a member of the British Association of Research Quality Assurance (BARQA) since the mid 1980s. Nicky has worked closely with the Institute of Clinical Research since 1996, she is currently Co-Chair of the GCP Forum and also works closely with the Ethics Forum and is a member of the new Symposia Working Party working to provide training and information to people involved in clinical research.
She joined EFGCP in 2003 and is an active member of the Ethics Working Party and the Audit Working Party. In March 2007, she became an elected Governor for her local NHS Foundation Trust Hospital; she was subsequently re-elected in 2010 and became Lead Governor on 1st February 2011. During 2009, she became a Chartered Scientist, and award from the Science Council in the UK through the Institute of Clinical Research which is awarded to individuals who are professional scientists, who are practicing and/or advancing science and for whom this is an integral part of their daily work. In 2010, she began the recently accredited EMWA Workshop on Quality Awareness in CSR Development.
About Premier Research
Premier Research is a professional services company providing clinical development support to the pharmaceutical, biotechnology, and medical device industries. Founded in 1989 and headquartered in Philadelphia, USA, the company currently has 22 offices spread across Europe and North America and operates in over 30 countries worldwide. The company is a leader in performing clinical research in the analgesia, oncology, pediatrics, medical device and neurosciences areas. Additionally, it has grown a strong strategic sourcing group that supports customers in their resource planning and management.
The company offers a comprehensive series of services for every phase of clinical development including, regulatory affairs, clinical trial management, medical affairs and strategic consulting, pharmacovigilance, data operations, biostatistics, medical writing, IVRS/IWRS, and quality assurance.
For more information please visit, www.premier-research.com.
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