Easily build, review, publish and validate paper CTDs, NeeSs, legacy/rest-of-world submissions, clinical study reports and other reports with TRS Publisher.
The global nature of the pharmaceutical industry demands that companies be adaptable to many submission formats and varying regulatory requirements. Such adaptability can be tricky to achieve, because even the same format can have variations from one region to the next. As an integral tool for managing the full gamut of regulatory submissions, TRS Publisher helps biopharmaceutical companies build, review, publish and validate paper Common Technical Documents (CTDs), nonelectronic CTD electronic submissions (NeeSs), legacy/rest-of-world submissions, clinical study reports and other generic reports.
TRS Publisher offers flexible structures for the creation of tables, figures, listings and tables of contents; for metadata stamping; and for large-scale paper dossier output, including PDF, Job Definition Format, PostScript and XPF. It also provides for seamless electronic document management system integration with Documentum, Livelink, IBM SCORE, SharePoint, FirstDoc and FirstPoint.
A scalable enterprise-document publishing solution, TRS Publisher offers simple, process-driven assembly and review of study reports, NeeSs and paper submissions. For those looking to minimize rework from an electronic CTD (eCTD) to a paper or NeeS copy, TRS Publisher seamlessly imports an eCTD and creates a paper output. TRS Publisher can also be tightly integrated into TRS FirstDoc and TRS eCTDXPress.
In addition to regulatory submissions, TRS Publisher assists companies with the creation of other professional publication-ready documents, such as annual reports and study reports.
What sets TRS Publisher apart is its use of a variety of templates that make publication creation easy and that remove the need to make duplicate selections and settings. Folder and document templates quickly select a publication structure. Publication templates hold the settings for such items as tables of contents, output locations and page stamping variables. Other templates are also available to create cover pages, to stamp headers and footers, and to format tables of contents.
- Folder and document templates. These ensure the ease of setting up publications that need to conform to multiple regional paper or non-eCTD requirements — with minimal yet significant differences and without having to create regulatory submissions from scratch. TRS Publisher provides multiple templates for region- or country-specific requirements and offers easy creation, storage and distribution of templates.
- Publication templates. These let users specify typical settings for each publication type. Then users simply select that template when creating a new publication. Once the template is selected, changes can be made to the settings without affecting the template. Use of these templates saves companies time when preparing multiple submissions with similar needs.