Erasmus Universitair Medisch Centrum Rotterdam (EMC)

Erasmus Universitair Medisch Centrum Rotterdam (EMC)

Erasmus MC Sophia is the largest academic paediatric hospital in the Netherlands with a dedicated pediatric pain management team. Paediatric Pharmacology and pharmacotherapy are major research topics within this institution, especially with respect to analgesic and sedative agents. Erasmus MC Sophia has a paediatric research trial office (Sophia Kindergeneeskunde BV) in charge of administrative and financial control of research projects of Erasmus MC Sophia with over 100 studies in portfolio, including several phase I-IV trials. As a part of the Sophia Kindergeneeskunde BV, the Sophia Research Group consists of over 25 qualified research nurses and coordinators who are working with investigators on paediatric (drug) studies at the Erasmus MC Sophia, providing excellent ICH-GCP knowledge, standard operating procedures for paediatric clinical research, and guaranteeing continuity of processes, ethical conduct of studies and high quality care for study patients and their parents. The Erasmus MC Sophia has recently adopted the Dutch Medicines for Children Research Network (MCRN) as a project within the research program in order to be able to better coordinate (international) multicentre investigator initiated drug studies in the Netherlands. The MCRN has excellent knowledge on research logistics and IRB procedures in the Netherlands, high level coordinating skills and access to many investigators and experts.

Main tasks in the project

Within the project, EMC will lead all the activities related to the design, preparation and implementation of the GABA-2 trial (WP8) in close collaboration with GABA-1 (WP7). As such EMC will coordinate the GABA-2. EMC will participate as recruiting centre for both GABA-1 and GABA-2 clinical trials and in all the commonly shared activities of the GAPP project.

Involved staff

Saskia de Wildt: Medical Doctor 1996, PhD 2001 degree (developmental aspect of midazolam metabolism) from Erasmus University Rotterdam. Clinical training in paediatrics (2005), paediatric clinical pharmacology (2008) and intensive care (2010).Current research interest: paediatric pharmacology, with emphasis on pain and sedation trials and oral drug absorption. Paediatric anaesthesiologist at Erasmus MC Sophia.

Tom de Leeuw: Medical Doctor, paediatric anaesthesiologist at Erasmus MC Sophia since 2000.

Tjitske van der Zanden: Project manager MCRN (2012) Project manager Nederlands Kenniscentrum voor Farmacotherapie bij Kinderen and Paediatric Formulary (2006-present), Member IRB Erasmus MC (2003-2010); Quality control manager clinical research Sophia Kindergeneeskunde BV (2003-2006) Research coordinator Erasmus MC Sophia Kinderziekenhuis (2001-2003); Post graduate training research nursing, 2002, Bachelor in nursing 1998.

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