Posts Tagged ‘Argus Safety’

A couple of weeks ago, a client of ours discovered a problem in the production (PROD) environment of one of their clinical systems. In the initial system implementation, they had opted for a single environment (without a sandbox, development, training, test, or validation environment), so they found themselves with no separate environment in which to […]

In my colleague’s last “cloud fact or fiction” post, he confirmed that clinical trial, clinical data, and safety systems can be implemented faster in the cloud than on-site because a vendor’s data centers, servers, and templates are ready for use by companies with strict regulatory and compliance guidelines. Today, I’ll discuss implementation costs. Claim #2: 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 […]

Oracle’s Argus Safety is a comprehensive safety and pharmacovigilance platform designed to enable pharmaceutical, biotechnology, and medical device companies, in addition to contract research organizations (CROs) and academic institutions (AROs) to focus on product safety and regulatory compliance. With the multi-tenancy feature in Argus Safety, CROs and AROs can provide services to multiple sponsors, while […]

My recent trip to a new client in Hull, United Kingdom, reminded me of a Harvard Business Review management tip that is hard to argue. It conveyed three ways to start your client relationship right to ensure success: Make an accurate first impression. Make them feel comfortable, but also set clear expectations about what you can […]

In recent years, we have seen many changes to the global “face” of product safety (FDA, 2009). Arguably, these changes modify the traditional focus of product safety from a case management and alert reporting strategy to include a more preventative, pharmacovigilance strategic focus. In order to successfully adopt these changes, it is critical that we […]

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 […]