Oracle has introduced version 7.0 of its Argus Safety database
application, a cloud-based product that allows health care firms to
report and
manage data from adverse drug events.
Companies in the pharmaceutical, biotech, contract research and
medical device industries use Argus to manage product safety. They must
report information from these data sets to
the FDA or corresponding agencies in respective countries, such as the EMA
(European Medicines Agency).
Argus 7.0 helps drug developers comply with the FDA 21 CFR Part 11
regulation, according to Oracle. The regulation states that electronic
records and signatures must adhere to "predicate rules," or rules
governing records in a regulatory environment.
As pharmaceutical companies co-market and co-develop more drugs,
managing safety data sets for individual drugs has become more complex,
Martin
Young, Oracle's vice president of product strategy, told eWEEK. Argus
allows these firms to keep data sets separate for multiple clients.
"Product development in the health sciences industry is increasingly
virtualized and complex, often spanning the globe and requiring
the management of safety data from numerous co-marketing, in-licensing
and partner entities," Neil de Crescenzo, senior vice president and
general
manager for Oracle
Health Sciences, said in a statement. "Health sciences enterprises and their partners seek secure and efficient ways to manage this data across
partners."
Announced on May 4, Argus Safety 7.0 adds features for standardized
configurations and rules management and management tools for
coding dictionaries. The product's dashboards and metrics allow life
science organizations to report safety data as well as create specific
rules and
partitions of data to comply with regulations.
The software also adds a new portal to manage safety priorities using a single interface.
"When you have a drug on the market, you need to capture information on the safety of that drug in real-world use," Young
said. "If you get a spike in serious adverse events, then that's something
you need to be watching and reporting on, and that can have an impact on the drug."
The tool also features signal detection and proactive risk-management capabilities across a product's life cycle.
Companies are looking for a complete view of a drug's safety, from clinical development to post-market, Oracle reports.
Meanwhile, on May 4 Oracle also introduced updates to three products
that help researchers run clinical trials: Clinical, Remote Data
Capture and Thesaurus Management System.
Oracle Clinical provides a single application architecture to handle
both clinical data management and the remote capturing of data, and
Remote
Data Capture is an application that allows users to capture and scale
data to
support designs of complex clinical studies.
Clinical and Remote Data Capture will now allow users to create
different schedules and assessments for disease states, and compile
dynamic case report forms to mark patient progress.
Remote Data Capture adds extended text fields to handle date and time stamps to make auditing and compliance easier.
"The latest versions of Oracle Clinical and Oracle Remote Data Capture reinforce
Oracle's commitment to delivering feature rich, easy-to-navigate and scalable
solutions that help to enhance user productivity and increase overall trial
efficiency," de Crescenzo said.
Thesaurus Management System streamlines the classification of medical
and drug terms by providing a central repository in which to search
for them using advanced algorithms. It also allows drug developers to
code data
in a standard way for every trial, Young said.
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