eCTD Submission with TRS eCTDXPress
Simplify the job of creating, managing and reviewing eCTD submissions.
In today’s electronic world, the electronic Common Technical Document (eCTD) is the accepted ectd format for regulatory submissions to most of the major markets. Biopharma companies need to ensure that they’re managing their eCTD submissions in the most effective way. As the leading electronic submission product used by biopharmaceutical companies, TRS eCTDXPress is a scalable solution that simplifies the job of creating, managing and reviewing eCTD life cycles.
TRS eCTDXPress is used by top-50 companies, as well as midsize and emerging companies. It conforms to current International Conference on Harmonisation and regional requirements for delivering eCTD submissions. Most important, eCTDXPress offers functionality for the building, reviewing, compiling, validating and archiving of eCTD submissions.
eCTDXPress stands out for its:
- Simplicity and efficiency. Wizards and automated processes eliminate the time that companies would otherwise spend on manually processing eCTDs, thus creating efficiency and doing away with costly errors.
- Adaptability. Moving from non-eCTD format or paper format to eCTD format is made easy because TRS eCTDXPress can import from various sources and create the eCTD backbone, complete with hyperlinked and bookmarked documents, thereby giving companies a head start for future eCTD applications.
- Flexible delivery options. TRS eCTDXPress’s Web-based architecture can be deployed to meet the needs of companies of any size and at any level of eCTD adoption maturity. TRS eCTDXPress can be purchased as a standalone, modular application or as part of CSC’s Total Regulatory Solution Suite. The product can also be delivered as a scalable enterprise solution, as a hosted Software as a Service (SaaS) solution or as a packaged, scalable, entry-level desktop solution.
- Software as a Service delivery. CSC delivers its SaaS solution as a prebuilt, fully qualified virtual environment using VMware technology and allowing for a cost-effective, single-tenant SaaS model. VMware technology separates the software from the underlying hardware, allowing a single computer to run multiple operating systems and applications. This in turn allows for rapid deployment of a stable system with minimal onsite validation and changes in configuration. The solution can be configured and validated in a single or multiserver environment.
- Integration. TRS eCTDXPress integrates with many of the other Total Regulatory Solution products, including FirstDoc, TRS Publisher and TRS Viewer. Such integration results in unparalleled efficiency and expert management of submission building, submission review and submission life cycle.