CSS Informatics provides complete solutions for automated electronic
submission of Individual Case Safety Reports (ICSRs) and Suspected
Unexpected Serious Adverse Reactions (SUSARs). We have experience
transmitting
to FDA, EMEA, and numerous EU Competent Authorities (CAs).
 Our configurable
E2B Electronic Reporting Package includes:
 Integration
with any adverse event reporting system (Empirica Trace,
Argus
Safety, ARISg,
Oracle AERS, and any custom, Oracle-based application)
A
comprehensive and flexible mapping from your drug safety
application to the E2B specifications using our
TableTrans software
Integrated
verification of data integrity prior to submission
using our proprietary E2B Verification Wizard
ICSR
/ SUSAR files
generated in XML format
Transmit
using a secure connection with encryption (AS1, AS2, or AS3)
Processing
and permanent storage of Message Disposition Notifications (MDNs) and Acknowledgment messages
Direct
integration
with your workflow and drug safety database
Import
capability for accepting ICSR files from regulators or business partners
Multiple
ICSR Browser components
Automated
e-mail notification of configurable events like transmissions and
acknowledgments
Complete
E2B Validation Package
All
the Benefits listed below and more!
Click
here for a
more comprehensive overview or
contact us for more information.
Benefits
of our E2B
Server / ICSR Browser Solution
A cost-effective package
with low annual maintenance. No astronomical, annual costs for
gateway software.
Proven
E2B experience - we developed the first commercial E2B export /
import application in the 1990s and continue to innovate.
Web-browser
modules provide affiliate and partner access without requiring direct
access to your drug safety software.
Comprehensive
E2B Validation Package assures full compliance with our E2B software or
anyone else's.
Minimum
requirements may allow you to use existing hardware and software.
Extend
the capability of your client/server drug safety software without
requiring expensive upgrades.
Always
compliant with requirements from FDA, EMEA, and EU Competent
Authorities.
All
about our E2B ICSR Browser
Our web-based E2B ICSR Browser works with Internet Explorer 5.5 and later. It
uses either your Oracle8i (and later) HTTP Service or the Oracle
Application Server (OAS). In many instances, clients do not have to
make additional hardware or software purchases for their existing environment
before integrating our solution!
With the complete
suite of features in our E2B ICSR Browser, affiliates,
partners, and
remote users can:
Access
the application remotely via your company's LAN or VPN
Preview
a list of cases filtered by suspect drug,
country of origin,
seriousness, expectedness and other elements
Review
case summary information for each ICSR w/o requiring full
access to your drug safety application
Add
country-specific comments for local regulators
Verify
that the case meets ICH and regulatory rules and guidelines
Select
the regulator(s) to receive the ICSR / SUSAR
Submit
an ICSR / SUSAR to multiple regulators simultaneously
Monitor
the status of an ICSR from submission to acknowledgment
Review
Acknowledgment Messages for errors and warnings
Restrict
user processing by Regulator and Product
Receive
automated e-mail notification of success and failure points in
the E2B submission process
E2B Submission
Software Compatibility
Our E2B
electronic reporting software is currently in production with
commercial applications like Empirica Trace and
Oracle AERS in both the US and the EU. The flexibility of
our design assures compatibility with any contemporary, drug safety
database including Argus and ARISg. Our E2B submission software is compliant with 21 CFR Part 11, EMEA, and ICH guidelines.
If you are a CRO, pharmaceutical
or biotech company and would like to
participate in our E2B R&D Partner Program, please contact Stuart Pearce:
+44 (0)
1227 363355 or
email us here
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