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.