Regulatory Compliance

  On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: The Scope section requires access to electronic records and signatures (ER/ES) at all times. What if the electronic system used by a […]

  We recently discussed customizing and configuring clinical trial software that is hosted in the cloud. For the final post in our “cloud fact or fiction” blog series, we’ll discuss the hot topic of validation. 

Compliance has become a strategic and executive-level imperative for financial services organizations. Capturing data to meet regulatory requirements in reporting, risk management, and compliance is timely, expensive and challenging because it requires gathering, enhancing, and reporting the required data from multiple data sources. Thomson Reuters’ sixth annual “Cost of Compliance” study was just released this past […]

  On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: What about GAMP 5? How does it fit into 21 CFR? How to combine both? 

  Warnings letters stink, as they can impact a company’s image, stock value, and much more. That’s why companies should do everything in their power to make sure they follow FDA regulations to a “T.” 

  Last week, the FDA released a new draft guidance document called Adaptive Designs for Medical Device Clinical Studies. While the title specifically calls out “medical device,” the document states the following: 

  I’m not going to get into whether prescribing or using drugs for off-label purposes makes sense – you can decide that for yourself. However, what I will tell you is that it’s a hot topic in the industry right now. Pharmaceutical companies continue to lobby the FDA to eliminate any prohibition of off-label promotion […]

  When it comes to periodic reporting, we feel that the generation and tracking of periodic reports in Oracle’s Argus Safety is far easier than in other safety and pharmacovigilance systems. In the system, periodic reports are all created and generated from a central screen within the application.   The four basic kinds of periodic […]

  In our last “cloud fact or fiction” post, we discussed the ability to migrate clinical and pharmacovigilance data to the cloud. Let’s jump right in and talk about system integrations in the cloud. Claim #7: Clinical trial software in the cloud cannot be integrated with other systems. 

  On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: When Argus is hosted by Perficient, is it considered an open or closed system for the company that contracted Perficient to host? 

  Pharmaceutical companies often donate their products to those in dire need, but it hasn’t been especially clear how adverse events for donated products should be handled. In light of recent public health programs to fight neglected tropical diseases, the World Health Organization (WHO) asked the European Medicines Agency (EMA) to clarify the marketing authorization […]

  In Argus Safety, all of the parameters for configuring the worldwide regulatory reporting rules are clearly identified on a single administration screen. You have the capability of selecting various case or event-level attributes, as well as using very advanced conditions, to focus the automated triggering of these report rules in various circumstances.