When it comes to periodic reporting, we feel that the generation and tracking of periodic reports in Oracle’s Argus Safety is far easier than in other safety and pharmacovigilance systems. In the system, periodic reports are all created and generated from a central screen within the application. The four basic kinds of periodic […]
Posts Tagged ‘Argus Safety’
Can We Integrate Clinical And Safety Systems In The Cloud?
In our last “cloud fact or fiction” post, we discussed the ability to migrate clinical and pharmacovigilance data to the cloud. Let’s jump right in and talk about system integrations in the cloud. Claim #7: Clinical trial software in the cloud cannot be integrated with other systems.
The 6 Annual Release Dates For MedDRA And WHO Drug
In a post from earlier this year, Medical Coding In Argus Safety, Perficient’s Dr. Rodney Lemery discussed how Oracle’s safety and pharmacovigilance (PV) system integrates very nicely with MedDRA and WHO Drug. Since much of the work our safety and PV team does revolves around Argus Safety, we’re also heavily involved with the installation […]
Are Hosted Systems Open Or Closed Under 21 CFR Part 11?
On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: When Argus is hosted by Perficient, is it considered an open or closed system for the company that contracted Perficient to host?
Release Notes: Oracle/Perficient’s Clinical Apps [May 2015]
Perficient’s Life Sciences practice regularly monitors the software release notes for several Oracle Health Sciences applications, as well as our own clinical and safety systems.
Top 5 Life Sciences Blog Posts From April 2015
Now that May is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in April – they’re ranked in order of popularity, with number one being the most viewed piece.
Even For Charity, EU Drug Makers Obligated To Report AEs
Pharmaceutical companies often donate their products to those in dire need, but it hasn’t been especially clear how adverse events for donated products should be handled. In light of recent public health programs to fight neglected tropical diseases, the World Health Organization (WHO) asked the European Medicines Agency (EMA) to clarify the marketing authorization […]
Regulatory Reporting Rules In Argus Safety
In Argus Safety, all of the parameters for configuring the worldwide regulatory reporting rules are clearly identified on a single administration screen. You have the capability of selecting various case or event-level attributes, as well as using very advanced conditions, to focus the automated triggering of these report rules in various circumstances.
Where Did The Name Argus Safety Come From?
I was recently listening to the radio and heard about a book “Who Knew?: Things You Didn’t Know About Things You Know Well” and it reminded me of a story that that our safety and pharmacovigilance director, Dr. Rodney Lemery, told during a webinar earlier this year. Where did the name Argus Safety come […]
Regulatory Report Tracking In Oracle Argus Safety
One of the things we hear most is how simple Oracle Argus Safety is to navigate. In the image (click it to enlarge) above, you’ll notice a familiar folder structure in the upper part of the Regulatory Reports screen – it looks just like Windows Explorer and works similarly. It allows you to drill […]
Top 5 Life Sciences Blog Posts From March 2015
Now that April is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in March – they’re ranked in order of popularity, with number one being the most viewed piece.
Medical Review In Argus Safety
Much like the Coding Review screen, the Medical Review screen is functionality in Oracle’s Argus Safety that displays the relevant case in a single central window and allows a medical reviewer to see all of the key data points that he or she would use when assessing the case.