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Estonian Network of Paediatric studies

ELAV is a network coordinating paediatric clinical trials in Estonia. We provide support to investigators in initiating trials, training study teams, and sharing experiences. Our team consists of experts in paediatrics, neonatology, pharmacology, and clinical trials. We have experience with academic and industry-led trials and are dedicated to innovative study design and integration of electronic health systems.

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Estonian Network of Paediatric studies

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  1. Estonian Network of Paediatric studies Irja Lutsar Tallinn, 20. March 2019

  2. c4c is looking for clinical experts • https://conect4children.org/2019/02/25/cal l-for-clinical-and-methodology-experts/ Gastroenterology & hepatology Endocrinology & Diabetes Reumatology & Autoimmune diseases Infectious diseases & Vaccinology Cardiology Neuroscience & epilepsy Neuromuscular diseases Metabolic diseases Oncology Nephrology RSV Respiratory Intensive care Psychiatry Neonatology Adolescent Medicine lead Nick Croft lead Thomas Danne lead Nicola Ruperto lead Theoklis Zaoutis lead Wim Helbing lead Helen Cross lead Volker Straub lead Maurizio Scarpa lead Gilles Vassal lead Franz Schaefer lead Louis Bont lead Jonathan Grigg lead to be nominated lead Alessandero Zuddas lead Karel Allegaert lead Alessandero Zuddas

  3. ELAV • Was established based on mutual agreement between University of Tartu, University Clinics of Tartu and Tallinn Children’s Hospital • ELAV is part of Clinical Trial Unit of University of Tartu • General aim to coordinate paediatric clinical trials in Estonia • ELAV is lead by the board of 5 people

  4. Main tasks of ELAV • “One stop shop” for pharmaceutical industry and academic researchers • To support investigators in initiating clinical trials (ethics, regulatory submission) – Together with clinical trials unit • To support study teams with training (GCP training) • To enable to share experiences in conducting clinical trials

  5. Team members • Estonian Network of Paediatric studies (www.elav.ee) • Two level 3 paediatric hospitals involved – Small and complex studies • Wide variety of expertise in the group – Paediatrics, neonatology, pharmacology, clinical pharmacy, analytical science, study nurses – Modelling (incl. PK modelling), clinical trials • Mostly academic trials but also experience with industry led trials • Recent international trials – NeoMero, Mon4Strat, Closed, NeoVanc, Neurosis, Albino • Recent local trials – DosOpt, • Supporting systems are in place – Clear and transparent processes (regulatory, ethics, contracts)

  6. What ELAV has done thus far? • Each year one meeting related to paedaitric reseach • Both paediatric hospitals have research nurses (funded by ELAV) • ELAV is member of c4c

  7. Estonian Network of paediatric studies

  8. Our contribution • We have several years of experience in designing and conducting paediatric studies including PK studies and premature neonates among others – Currently there 11 academic clinical trials ongoing • We would like to contribute in innovative study design and conduction, integrating electronic health system to clinical trials – No data transcription – Data collection directly from hospital records and monitoring devices – Using electronic prescriptions to record medications (concomitant and study) – Data transfer from computer to computer rather than data transcription from hospital records that requires quality control – Establishing Baltic cooperation

  9. • Team members • Characterisation of beneficiary • Competence • expectations

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