Specialised Services: Paediatric Studies

Children are not "little adults", especially from the perspective of developmental physiology. As numerous examples have demonstrated, it is often not possible to simply adjust the dosage of drugs that are successfully used on adults. Finally, it has been recognised that only by conducting targeted clinical studies on minors will it be possible to conclusively remedy the problem of children as "therapeutic orphans".

Since 2008, new rules are applicable for clinical studies with paediatric study populations. Authorities have recognised that the fact that more than 50% of all pharmaceutical products used are not licensed either for children or adolescents creates a situation which represents an unacceptable risk for this patient population. More clinical studies with minors are needed to obtain data and pharmaceutical licensure for this population as well. However, the regulations and requirements are very strict for studies in which infants are part of the patient group.

GCP-Service conducts clinical studies with minors. The company has conducted studies with up to 5500 children, which was only possible due to GCP-Service's enormous pool of paediatric study centres and well trained staff. Professional trainers provided more than 100 paediatricians and study nurses with certified training in clinical research, ICH GCP and national regulations to ensure the welfare and rights of this study population while providing reliable study data.