Posts Tagged ‘Argus Safety’

Now that February 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 January – they’re ranked in order of popularity, with number one being the most viewed piece. 6 Trends In Life Sciences […]

Attaching files to a case is an important aspect of case management work processes. Typically one would attach source documents here, such as a discharge summary report, a hospitalization record, patient laboratory records, etc. Without formal integration to a document management system, it’s quite easy to maintain safety source documentation by attaching a file in […]

Whether you’re using Oracle’s drug safety and pharmacovigilance solution, Argus Safety, a different application from another vendor, or even Excel to capture and manage adverse event data, our January 29th webinar, Features of a World-Class Safety System may be of interest. Dr. Rodney Lemery, the director of Perficient’s life sciences safety and pharmacovigilance division, is […]

In our last “cloud fact or fiction” post, we pointed out that hosting your clinical trial software in the cloud gives companies unparalleled access to their data due to high system uptime and ease of access to systems. This time around, we’ll discuss cloud security. Claim #5: Clinical and safety data in cloud systems is not […]

A major part of the case management process is to ensure that every adverse event term is coded appropriately to the medical dictionary MedDRA. Oracle’s Argus Safety makes coding verbatim terms quite simple. The system integrates very smoothly with the medical dictionaries MedDRA and WHO Drug. Per current MSSO Points to Consider (MSSO, 2014), adverse […]

As we wrap up 2014, I thought it would be neat to see what our readers were, well, reading. Without further ado, here are the top 10 blog posts Perficient’s life sciences practice wrote that seemed to be popular among readers. They’re ranked David Letterman-style, one being most popular (i.e., viewed). The One Feature CROs and […]

In a previous post, we discussed that Oracle’s Argus Safety makes entering and managing adverse event cases relatively simple due to its intuitive user interface. For this post, we’ll discuss working in the event and product assessment screen and look at a few of its key features. One main requirement for any safety system is […]

Last time, we concluded that the costs associated with hosting clinical trial software in the cloud can actually be less than for on-site solutions. In this post, we’ll tackle access to data and system uptime. Claim #4: Clinical or safety data stored in the cloud can be accessed at any time. Fact or fiction? Fact. […]

The electronic (or manual through the Safety Reporting Portal) reporting of post-marketed individual case safety reports (ICSRs) to the FDA will be required by mid-2015 (FDA, 2014), and the most efficient way to perform such activities is through an industry-proven adverse event reporting system, such as Oracle’s Argus Safety. Since this is the safety and […]

The pharmaceutical and medical device industries continue to be under close scrutiny by the FDA when it comes to product safety and the reporting of adverse events. With stringent regulatory requirements that’ll make any company or patient cringe, there’s no way to hide from authorities. And, rightly so. But, guess what? There are also adverse […]

Over the years we have seen some general confusion regarding the use of the FDA MedWatch 7-day report for fatal blood collection or transfusion reporting versus the standard 7-day alert requirement for FDA individual case safety reports from IND trials. Some of the safety systems that our company has worked with over the years do […]

In our last “cloud fact or fiction” post, we discussed the cost of implementing clinical trial software in the cloud. This time around we’ll address the ongoing costs you can expect to see if you decide that hosting your applications in the cloud is the way to go. Claim #3: Ongoing costs for cloud/hosted clinical […]