Regulatory submission support

Whatever your statistical programming submission needs, Accovion has the tools and expertise to support you. We can help you plan the data submission process and deliver documents ready for eCTDs. Following the FDA’s requirements, our analysis data sets are “one PROC away” from your results. Adherence checks against regulatory requirements and cross checks against analysis results will be added in the submission process to ensure consistency. Accovion will supplement your data with high quality annotated case report forms and data definition documents, i.e. DEFINE.PDF as well as DEFINE.XML.

Contact us

Beate Hientzsch
Director Statistical Programming

+49 6196 7709-406