The eCentral™is an all-inclusive, web-based, regulatory-guided platform designed to increase business performance and efficiency. It supports and facilitates content and document management, business process workflow design and execution, and regulatory publishing task performance tracking.
The eCentral™ Repository provides database and content-addressable storage alternatives for long-term archive storage. It offers document tracking, management, organization, version control, and security functionality for diverse file formats, including MS Word, PDF, spreadsheet, scanned images, manufacturing diagrams, and text. The eCentral™ Repository also organizes and aggregates documents for business process speed and enhanced productivity.
The PDF Editor™ is a robust and versatile web-based solution for PDF management, modification (bookmarking, linking, pagination, etc.), and standardization that will significantly ease the task of creating “eSubmission Ready” documentation from non-standardized and seemingly disparate document sources.
The eLabel™ is a web-based part of eCentral™ that facilitates the creation and management of the content of labeling files in the newly required compatible SPL format and their related submission. This includes Self-ID, establishment registration, NDC label code request, ACA6004, ICSR, and complete document validation according to precise FDA standards.
The eCompliance™ is an eCentral’s data publishing module designed to facilitate compliance with emerging CDISC requirements, including the SDTM, SEND, and ADaM models. It can be utilized in SAS analysis and standardization tasks and the successful generation and publishing of data definition tables in the PDF and XML format for inclusion in eSubmissions.
The eAuthor™ contains a complete set of MS Word document templates designed to guide submission content authors toward proper document formatting, styling, and content inclusion to adhere to the eCTD standard. eAuthor™ includes a unique document template for every level of eCTD granularity and can be deployed for full integration within eCentral™ and MS Word.
Repository and Workflow Function Within eCentral™
The eClinTrial™ enables the Electronic Capture of Data (EDC) in a CDISC Compliant format, moving the data compliance issue further upstream and addressing it where it is most manageable, at the point of data collection. With eClinTrial, we can turn compliance into a competitive advantage—ensuring that your clinical trial, data management, and eSubmission publishing processes are fully integrated and the most efficient. MedXview can help you get your products to market much more quickly and compliantly.
The eLims™ is designed to be simple and easy to scale up. Our rich out-of-box functionality is continually enhanced based on industry best practices. MedXview focuses on functionality and ease. Our solution is 100% web-based and easy to use. Using powerful configuration options allows you to tailor the solution the way you want it so you can maximize the value of your LIMS over time.
The eDesigner™ enables process execution to tie in directly with business objectives, automatically adjusting business processes.
eCentral Workflow Engine™
The eCentral™ Workflow Engine™ provides up-to-the-moment statistics about productivity, workloads, goal attainment, and process anomalies, allowing managers to drill down on data and “slice and dice” from different perspectives.