Posts Tagged ‘drug safety system’

Currently, two of the FDA branches have released guidance documents and have implemented a form of E2B(R3). Center for Biologics Evaluation and Research (CBER) has released “Providing Submissions in Electronic Format — Postmarketing Safety Reports for Vaccines” and the Center for Devices and Radiological Health (CDRH) has released “Technical Information on eMDR.” While both of […]

After the release of E2B(R2), the ICH realized that technical specifications should no longer be developed in isolation. E2B(R3) is the first technical specification to be developed through a new collaborative approach. E2B(R2) Vs E2B(R3): Regulation and Interoperability The International Organization for Standards (ISO), Health Level Seven International (HL7), and European Committee for Standardization (CEN) […]

E2B(R3) doesn’t have a direct translation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) published guidelines that have designated “E” to stand for efficacy. The work carried out by ICH under the efficacy heading relates to the design, conduct, safety, and reporting of clinical trials. It also […]

The electronic transmission of adverse event information to stakeholders, using the International Conference on Harmonisation “E2B” standard, is an essential component of global drug safety and pharmacovigilance operations. E2B(R3), the latest version of the International Standards Organization (ISO) Individual Case Safety Report (ICSR) standard, includes new requirements with which product manufacturers and the organizations that […]

  If you’ve been waiting to implement Argus Safety 8.x or upgrade your existing environment, the wait is finally over. While the new version was released last year, it takes several months to build a comprehensive validation suite, and I’m happy to announce that Perficient’s life sciences group has completed that task. On top of […]

  We recently discussed what CAPA means and why it’s important. Since many people in our field express confusion between the “CA” and the “PA,” I’ll quickly explain the difference between corrective action and preventive action. To put it simply, a corrective action can be defined as specific steps taken to address observed non-conformities or […]

Code list maintenance is critical in Oracle’s Argus Safety. These code lists often present as drop-downs in the case entry sub-system. While the entry, modification or removal of these list of value options are very convenient, it does take some effort to ensure the reliable data points that are used everywhere in the system are […]

  One of the other major benefits of Argus Safety, Oracle’s drug safety and pharmacovigilance system, is the ability to maintain administrative tasks in an easy-to-use interface. The following blog post reviews some of the very simple possibilities of configuring Argus Safety to your own needs with minimal technical effort. 

  We recently discussed the ability to access previously visited adverse event cases very quickly in Oracle’s safety and pharmacovigilance system, Argus Safety. For this post, we’ll cover a feature that many of our clients love. Argus Safety enables users to open multiple cases simultaneously, although it’s not possible to view both of the cases at […]

  The last post we wrote on Argus Safety features was about the system’s autocomplete functionality. Another great feature of Oracle’s safety and pharmacovigilance system is the ability to quickly go back to an adverse event case that you previously accessed. This can be done in just a couple of clicks from the menu, saving you […]

  Now that July 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 June – they’re ranked in order of popularity, with number one being the most viewed piece. 

  Last week we covered dashboards in Oracle’s Argus Safety. Today we’ll talk about Worklists. Worklists in the drug safety and pharmacovigilance system can be seen as the end-users task list for the day. While there are many Worklists to help organize a company’s users, today we will focus on two of the main ones, which […]