Posts Tagged ‘pharmacovigilance system’

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 […]

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 […]

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 […]

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 […]

Anyone evaluating clinical trial, clinical data, and safety management systems today will also need to decide whether to implement on-site or in the cloud. As each year passes, more and more companies are choosing the cloud for a whole host (pun intended!) of reasons. Over the next few weeks, my colleagues and I will examine […]

Deciding “if, when or how” to move from one safety application to another can be a daunting task full of angst, pressure and fear of the unknown. Arguably, most of this distress is experienced in the initial analysis of the migration options and sifting through the solutions available to an organization. This blog entry will attempt […]

Jody Trader, a pharmacovigilance and drug safety specialist at MMS Holdings, a CRO based in Michigan, recently published a blog post on whether or not Microsoft Excel was sufficient for capturing and reporting adverse events. Since validated safety databases, such as Oracle’s Argus Safety, are often costly, sponsors and CROs continue to use spreadsheets for […]

In a few days, Perficient will be attending the 19th Oracle Health Sciences User Group (OHSUG) annual meeting in St. Louis. I have been privileged to attend all previous user group meetings, beginning with the very first one back in 1996 in Ann Arbor, Michigan. Approximately 100 people gathered in a conference room at Parke-Davis […]