 Requirements analysis and vendor selection
Deciding which drug safety software (Empirica Trace, Oracle AERS, Argus Safety, ARISg) to implement is
a major decision. We have years of experience with these systems
and can provide unique insights throughout the evaluation process.
In addition, our ongoing consulting projects with all four systems
allow us an unprecedented perspective on system issues and market
trends.
Database configuration
Adverse drug event reporting systems are flexible in allowing additional data items for specific
business requirements. Existing items can be modified and new items
added using supported
maintenance practices. Additionally, our custom reporting
environments can extend the power and usefulness of your drug safety
software by allowing you track employee metrics and prepare
uniquely-formatted reports for your weekly, monthly, quarterly and
annual business meetings.
Dictionary loading and configuration
Safety systems support a variety of medical coding dictionaries.
Though MedDRA and WHODRUG are most commonly used today, many companies
still utilize COSTART, WHO-ART, and ICDx, as well as proprietary dictionaries. We provide
services and software that allow you to:
> analyze the impact
of dictionary upgrades on your existing data
> automatically
update your existing, coded data
> improve the
adverse event hit
ratio of your auto-coding process against medical dictionaries and your
synonym database
E2B
electronic reporting
EMEA, FDA and EU competent authorities allow and even mandate
electronic E2B reporting now. Our own E2B ICSR Browser integrates
with any drug safety system and any gateway
software. Clients in the U.S. and Europe have been successfully
using this software in production environments for several years.
Legacy
data migration
Mergers, acquisitions, upgrades to web technology, and new capital
projects are leading to an increasing number of adverse event database migrations.
With more than ten years of pharmaceutical data migration experience and
150 successful data migrations under our belt, CSS Informatics is a
clear leader in this field.
Coding
systems: WHODRUG and MedDRA
We implement WHODRUG and MedDRA terminology in clinical and safety operations. Our
experience with WHODRUG and MedDRA dates back to the earliest versions and we are
familiar with current WHO, MSSO and regulatory guidance regarding
the use of these dictionaries. We are a core MSSO subscriber.
In addition, we work with companies to develop auto-coding algorithms for
Oracle TMS, Clintrial, and other systems to maximize the verbatim
term-to-hit ratio.
System
validation services
Our validation
services for drug safety software systems cover the four major, commercial systems:
- Aris Global ARISg™
- Relsys Argus Safety™
- Phase Forward Empirica™ Trace
- Oracle® AERS
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Support
services we offer include: