Reports

Reengineering using regulatory requirements

In medium and large pharmaceutical structures processes are defined on a departmental basis (e.g. monitoring, data management, biostatistics, medical writing, pharmacovigilance and regulatory affairs) resulting in huge workloads for the QC and regulatory affairs departments. Cardinal Systems, using the most recent definitions for submission requirements (ICH E3 and ICH M2 eCTD [and m1 regional variation]), reviewed traditional methods, processes and software in a cross-departmental way.

The resulting selected processes, softwares and methods permits us to manage every element within a full ICH E3 report from section 1 to 16.4 as a whole whatever the origin of the element (CARDS© elements, clinical setions, narratives, images of CRFs or any appendices).

Document management services

Cardinal Systems provides services for document management/integration including high-speed volume scanning, document conversion, PDF bookmarking and eCTD production. eCTDs are validated using ISO/W3 compliant parser.

Thanks to these services Cardinal Systems is able to integrate elements like clinical sections and narratives provided in RTF/PDF or image format into our document management software which, in turn, maintains logical cross-references and the table of contents.

Delivered products

Reports and full appendices are delivered/archived on CD-ROM ISO 9660 respecting the FDA's guidance for electronic submission/archiving (PDF supplied with all required bookmarks for documents and SAS Transport files (XPORT) for data).