An interesting thing happened in pharma and investing. It involved Regeneron and their July 24, 2015 FDA-approved cholesterol drug, Praluent. Forbes outlined the situation, which caused Regeneron stock to drop significantly, in a January 6, 2016 article. According to Matthew Herper, a Forbes columnist, investors got a hold of data from the FDA’s Adverse […]
Posts Tagged ‘Argus Safety’
The 10 Most Popular Life Sciences Blog Posts Of 2015
Welcome to the New Year! Similar to the way we share our most popular blog posts on a monthly basis, it only makes sense to look back at the most viewed posts from 2015. So, here it goes, with number one being the most read piece.
Release Notes: Oracle/Perficient’s Clinical Apps [Jan. 2016]
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. The systems covered in our review are:
21 CFR Part 11 Compliance For CAPAs In Argus Safety
We recently discussed how Oracle’s safety system has the ability to produce ad hoc descriptive statistical reports on quality data. This brings us to the last rule we’ll discuss in our “Argus Safety for CAPAs” blog series.
Release Notes: Oracle/Perficient’s Clinical Apps [Dec. 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. The systems covered in our review are:
Here’s How Quintiles Approaches Risk-Based Monitoring
I came across this three-minute video from Quintiles, which brilliantly discusses their approach to risk-based monitoring (RBM) and gives viewers a look into a day-in-the-life of an RBM monitoring team.
Ad Hoc Statistical Reports For CAPAs In Argus Safety
We recently touched on how Argus Safety enables you to track product complaint data and follow it through resolution. Today, we’ll discuss another CAPA rule the safety system supports.
Release Notes: Oracle/Perficient’s Clinical Apps [Nov. 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. The systems covered in our review are:
Recording CAPA Issues And Resolutions In Argus Safety
In our last CAPA-related blog post, we talked about the ability to attach supportive information to CAPA records (case data) in Argus Safety, Oracle’s drug safety and pharmacovigilance system. Today we’ll discuss another way the system can help comply with CAPA rules. CAPA Rule: System must allow the recording of issues and track their […]
Attaching Supportive Info To CAPA Records In Argus Safety
We recently talked about Argus Safety’s ability to able to uniquely identify cases. Today, we’ll touch upon how Oracle’s drug safety and pharmacovigilance system supports CAPA rule #3.
93 More Companies Chose Oracle Health Sciences Solutions
And that was just this past year. So, I think it’s fair to say that Oracle’s software is the cream of the crop in the life sciences and healthcare industries. According to a press release issued by the company, close to 100 life sciences companies have signed on to use Oracle’s clinical and safety […]
Release Notes: Oracle/Perficient’s Clinical Apps [Oct. 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. The systems covered in our review are: