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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: |
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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usage and historical document archival.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
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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. |
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 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. |
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 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. |
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 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. |
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| 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.
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