Archive | September 25, 2017

Three reasons you should upgrade to Oracle Argus Safety 8.1.x

Oracle Argus Safety is a leading Safety & Pharmacovigilance platform in the market. Oracle has been able to successfully move many sponsors from diverse drug safety platforms it built (Oracle AERS) or acquired (PhaseForwards’ Clintrace and Relsys’ Argus) to Argus Safety, making it their strategic safety platform of the future.

Upgrade to latest version of the platform has always been a challenging task for many sponsors, given the complex nature of configurations, customizations and integration with various clinical, regulatory and safety applications in the R&D ecosystem. Typically it takes anywhere between 1 to 3 years for customers to get onto the new release after the version is available. Of course this time line will change with the amount of changes the new version brings to the table. The impact of change will also determine the duration of the upgrade project/program. This has been the root cause for many customers delaying the upgrades in the past. Not to mention the cost associated with these upgrades.

The latest release, Argus 8.1 addresses new regulatory compliance requirements, functional enhancements and biggest of them all technology platform currency. In my opinion,these three things are key drivers to upgrade to Argus 8.1.x .

Regulatory Compliance Requirements: The new E2B (R3) reporting guidance for transmission of Individual Case Safety Reports based on Health Level-7 (HL7) messaging protocol provides an advantage to capture more data with increased granularity and frequency. ICH E2B(R3) is a mandatory regulatory requirement that all safety organizations need to be compliant with, in future. Different Health Authorities have different milestones / timelines for compliance. At this time it appears that PMDA (Japan) deadline of April 1st 2019 as the most impending one. Also many sponsors have implemented interim solutions to process EMA’s Eudravigilance ICSRs that are available in E2B (R3) format. The interim solutions have to be done away with and what better than meeting this requirement through the core platform. Also, electronic Vaccine Adverse Event Reporting System (eVAERS) and electronic Medical Device Reporting (eMDR) requirements, connected with E2B (R3) and important initiatives for Vaccines and Med Device sponsors are key requirements to be complied with.

Bug Fixes and Functional Enhancements: As with any of the past releases, Oracle has also addressed a lot of requirements pouring in from sponsors to fix some of the existing issues and enhance the platform to meet some new requirements. In 8.x there are over 350 Issues fixed. New Expedited Report Updates adhering regulations are added. There are also various Case Management Updates. There are a bunch of changes specifically targeting Argus J (i.e. Japan). Japan Development Safety Update Report (JDSUR) is enhanced replacement for ‘Clinical Study Periodic Safety Report’ (CSPSR). Also, ability to convert existing CSPSR report to JDSUR on Copying the Existing Report has been added. There are updates to PSR, ReSD, Global Lock and local data locks and local case data locks specifically for Japan.

Technology Platform Currency: Many existing technology platforms that support Argus platform have become outdated in the last few years. This has led to Oracle adopting newer versions of Windows, Oracle Database, OBIEE, Axway Interchange, Oracle B2B (new) etc. Also, some of the legacy technology platforms like Windows 2008/R2 are going out of support, not to mention premium support for Argus 7.x as well. The Technology platform changes themselves should be a big reason for sponsors to consider upgrade to 8.1.x.

More specific details around the bugs/enhancements as well as specific software versions in the technology platform currency can be found in Oracle Argus Safety 8.1 Release Notes.

As always, your feedback and comments are welcome. I would be very interested to hear from consultants and technologists in the trenches, driving the upgrades. Also from sponsors who are considering upgrades in near future (or not) .

P.S: This is my first post after a very long hiatus. But I plan to share my thoughts and opinions more often going forward. Thanks for your support and feedback.

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