• Standardized creation and accurate completion of study-specific documentation based on the requirements in study protocol and in eCRF (electronic Case Report Form, which is centrally provided by the respective sponsor for each trial). The corresponding Source Data Sheets, such as visit sheets, other source documents and forms, are created in our QM software roXtra under review by a 4-eyes principle.
• Through appropriate measures, we enable a data-protection conform study monitoring.
• The archiving of study documentation meets all requirements for confidentiality, integrity and availability of data in accordance with the relevant legal requirements. The Central Archive of Heidelberg University Hospital located at Heydt Verlag GmbH, Grenzstraße 11, Dresden, Germany, is used as the archive.

Through the standardized collection and documentation of study data, we contribute to valid and reliable results which increase the safety of drug administration in clinical routine.

A high-quality, complete patient data acquisition and documentation during the clinical development phase guarantees valid reproducible results on the efficacy and tolerability of a new drug. This determines its therapeutic value when used safely in clinical routine care, especially in vulnerable populations such as children and adolescents.