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MedXview's
products included both desktop solutions and Web server based solution -- an enterprise content management and submission publishing tool that today’s complex regulatory environment demands. MedXview consistently deliver superior overall quality and functionalities. We help your company in serveral key area such as:
Compliant with the latest international regulatory guidelines
Meets the stringent standards required by regulations like 21 CFR Part 11, the common technical document (CTD for paper submission) and the electronic common technical document (eCTD), Sarbanes-Oxley.
All-inclusive
All submission types supported such as eCTD, eIND, eNDA, eBLA, MAA, Paper CTD etc.
ALL regions supported for worldwide application include US, EU, Japan, and Canada
Best business practices
Harmonize and optimize your company workflow, route multiple R& D or submission documents for review and approval with audit trail capability.
Built-in included workflow engine and workflow template designer to improve efficiency and ensure project completion to eliminates need for cumbersome and expensive database engines
Reliable word-based SPL Editor and Web-based PIM Editor included for creation and management of your labeling content in the SPL and PIM formats
Slick SAS tool suite for creating Define.XML and Define.PDF, as well as clinical/non-clinical report generator.
Versatile PDF toolkits included for the modification, file management, and navigation of your PDF documents.
Complete Interoperability
Integrated with your current document and content management system such as documents or other repository products. Content within Documentum, Servers, Local File Systen, eCentral or other applications can be run side by side without the risk of compromising the control of regulated content. And eCentral can be supported with in both window and UNIX system.


 MedXview’s eCentral™


is a document repository specifically intended to facilitate accessibility of submission based documents, while providing a secure location for vital clinical trial information. eCentral™ safely houses files of any type including Excel worksheets, SAS datasets, PDF’s, and Word documents for both current submission usage and historical document archival. eCentral was created to ensure your 21 CFR Part 11 compliance.

eCentral™ enables document based permissions and restrictions for check in and check out capabilities. System users are supplied with a unique log-in for increased security, ensuring that only the appropriate personnel can access vital information. Users can delegate tasks with our unique workflow generator, dramatically improving efficiency and ensuring that all phases are completed in a timely and accurate manner. Automatic email notifications are sent to alert system users of tasks to be completed and alert workflow initiators of project status and completion. eCentral ™ is the most cost effective innovation available for total document control, security, and integrity, helping users become more efficient, share critical documentation company wide, and finish projects faster.

eCentral™ offers the following benefits for Document Management and Control:

Centrally store and access files of any type including XML files, statistical datasets, and PDF documents

Securely Check In/Check Out documents with single mouse click

Design workflows to improve efficiency and ensure project completion

Keep Attribute log and Comparison log for compliance and internal Audit Trail

Eliminates need for cumbersome and expensive database engines

Ensure 21 CFR Part 11

Archive submission documents and access new information


MedXview eCTDcomposer™ ensures a competitive edge, helping our users make fast and accurate eCTD submissions according to the federally mandated guidelines, including the creation of a valid XML backbone, Study Tagging Files, and the ability to manage the entire life-cycle for your product. Our MDG (MedXview’s Documentum Gateway) provides full integration with your Documentum from one intuitive and automated interface. eCTDauditor™ is the industry’s most powerful and versatile tool for validating, reviewing, and tracking your eCTD. With eCTDauditor™, users can view an eCTD submission just as regulatory agencies would.

 
MedXview DP2 Suite

Our DP2 (Data Processing and Publishing) is a suite of tools that allows our users to automatically generate files for Items 10, 11, and 12, such as CRT datasets, define.pdf files, xpt files, and TLF's. DefinePDFcreator™ is the most efficient application to automatically create the define.pdf file with all elements for E-Submission. TLFgenerator™a SAS-based software that allows you to create high-quality statistical tables, listings, and figures quickly and easily from all types of clinical data. Our SAS QC Explorer™ allows users to perform quality control tests on their raw and derived SAS datasets from on easy to learn interface. Users can check any aspect of their SAS data according to almost limitless specifications.

 
MedXview PDF Toolkit
MedXview PDF Toolkit

PDF files are widely used in the life-science industry giving rise to the current demand for intuitive and reliable PDF management and manipulation tools. MedXView’s PDF Toolkit™ has answered the call, giving both document authors and reviewers the power to edit, approve, and link PDF documents.

MedXview Rename™ is a standalone Windows application which helps users change file names. Rename™ has been especially vital in meeting the naming conventions established by regulatory agencies. MedXview Open Options™ is a standalone Windows application which helps users set their PDF display options. Open Options™ has proven to be a very useful tool for efficient PDF review according to the user’s individual specifications.


Introducing SPL Editor: The New Standard

As of Fall 2005 the FDA will require that the labeling content in regulatory submissions be submitted in SPL (Structured Product Labeling) format.The benefit of SPL implementation is that the transfer of information separates the document content from its format.This separation enables content to be shared through differing computer systems. SPL aims to facilitate communication amongst drug developers, product manufacturers, regulatory reviewers, and direct consumers.The concern, however, is the impact of this new technology standard on current business practices.SPL Editor? provides the technical capabilities for SPL generation without requiring major changes to current successful business practices.

SPL Editor Features:

    System generates XML Header
    Add Text: Main Sections and Sub-Sections
    Create valid lists: Bulleted and Numbered
    Use Special Characters
    Insert Images: JPEG and GIF files
    Build Tables in Valid SPL Format with:
    - Titles
    - Headers
    - Content
    - Footnotes
    Form based Drug Data Listing entry
    Preview your Output
    Built in SPL validation tool
    Publish valid SPL Documents

Professional SPL Conversion Services

In an effort to help clients meet their regulatory requirements, MedXview provides the service of converting current labeling content into the required SPL format.Our professional services team eliminates the need for you to hire and train additional personnel or implement and maintain software solutions.This approach allows you to focus on more pressing regulatory duties.

MedXview begins using your completed Microsoft Word Documents as source documents for SPL conversion.We can also create a new MS Word Document from archived/historical/printed labeling content.Clients receive notification of project completion and receive electronic copies of the valid SPL deliverables.These deliverables can then be sent directly to the FDA for proper review. Our consulting staff can also help to fill the gap, providing valuable SPL education for your team so that in time you can handle SPL creation in-house.Our clients have experienced the greatest return on investment when taking a dual approach, simultaneously taking advantage of our valuable software solutions and professional services.