Medical partner and clinical investigators

Paediatrics

Head of Department:
Prof. Dr. med. Joachim Wölfle

Information for medical partners and clinical investigators

Clinical trials in and with children are indispensable in order not to exclude our patients from medical progress. From the planning stage until the final implementation of a clinical trial, our medical and scientific actions are guided by an effort to minimise risks and stress for our young patients.

The Department of Paediatrics and Adolescent Medicine at the Universitätsklinikum Erlangen has been involved in paediatric clinical trials for many years, its actions naturally including vaccine trials, registration trials and investigator-initiated trials.

In order to meet the increasingly complex regulatory requirements for the conduct of clinical studies and to ensure highest quality standards, the Centre for Paediatric Clinical Studies was established in 2007.

All employees of the Centre for Paediatric Clinical Trials possess comprehensive expertise in the medical care of children and have perennial experience in the planning, organisation and conduct of paediatric clinical trials.

Our study assistants are registered nurses, medical and technical assistants or physician’s assistants who have completed additional study nurse training and who regularly continue their education.

Our services

Support to industry-sponsored clinical trials:

  • Acquisition, start up and implementation
  • High quality study conduct according to GCP
  • Query Management
  • Professional preparation of audits and inspections

Support to investigator-initiated/non-commercial trials:

  • Advice, planning and coordination
  • Budgeting, work flow and planning of resources
  • Development of trial protocols according to GCP
  • Trial registration, development of submission packages and submission to ethics committees and competent authorities
  • Trial coordination and project management
  • CRF development
  • Data management
  • Trial close out
  • Archiving
  • Pharmacovigilance (CCS)
  • GCP Training (CCS)

 

We closely cooperate with the Erlangen Center for Clinical Studies (CCS).

Experiences in clinical trails

To date we have conducted both investigator-initiated trials and industry sponsored studies in the following areas:

  • Arterial hypertension
  • Acute infections, e.g. influenza, RSV
  • Chronic infections, e.g. chronic Pseudomonas, hepatitis C
  • Vaccinations
  • Pulmonology, e.g. cystic fibrosis, allergies and asthma
  • Nephrology, e.g. immunosuppression, atypical HUS, hyperphosphotemia, renal replacement therapy, growth hormones
  • Haematology, e.g. haemophilia A/B, transfusion effects, deep vein thrombosis
  • Neonatology, e.g. nosocomial infections in preterm infants, bronchopulmonary dysplasia, spina bifida, sedation in neonates, hypercapnia in preterm infants, growth improvement in preterm infants
  • Hereditary defects, e.g. ectodermal dysplasia
  • Intensive care, e.g. sedation in children, acute pain therapy

Quality Assurance

All our activities are in line with the legal requirements and quality standards as laid down in national (German Drug Law, Medical Devices Act, GCP-V) and international guidelines and legislations (ICH-GCP, Directive 2001/20/EC, Paediatric Regulation (EC No 1902/2006), Declaration of Helsinki). In order to meet these requirements, we have established standard operating procedures (SOPs) for all areas so as to secure a high quality standard for all involved parties.

 
Contact

E-mail: paed-studienzentraleatuk-erlangen.de
Tel: +49 9131 85-41203

Head of Paediatric Clinical Study Centre
Team