Life Sciences

  Bayer. Then Abbott, Roche, and Lilly. And then the rest. Reputation Institute, a research and advisory firm that focuses on tackling and analyzing the reputation of companies worldwide, released its annual ranking of the most reputable pharmaceutical companies in the world. 

  In a handful of upcoming blog posts, we’ll be discussing a hot topic in our industry, along with a complementary piece of technology that might surprise you. The term Corrective and Preventive Actions, more commonly known as CAPAs, refers to an elaborate combination of processes and procedures used to maintain compliance with the following […]

  You’ve heard that saying before, right? Okay, it’s slightly different than the original one, which refers to IBM (one of our partners, too). But it’s true: to our knowledge, no client has ever regretted their implementation of the Google Search Appliance (GSA) solution. In fact, it’s quite the contrary. We consistently hear positive feedback […]

  According to a recent letter written in the South China Morning Post by Chien Wai-tong, a professor and the associate head (of research) in the school of nursing at Hong Kong Polytechnic University, one in about every four people in Hong Kong has been affected by a mental health issue at some point in […]

  In marketing, the amount of traffic to a website, blog, or other digital asset is important. Generally speaking, the more the merrier. It often defines success. What if I were to tell you that the same goes for your Intranet portals? You know, the places you go to search your company’s research papers, clinical […]

  Since President Obama’s State of the Union address in January, much has been said about precision medicine. And, rightly so. The ability to treat common and rare diseases based on genomic and patient data is showing incredible promise. However, the medical community agrees that significant changes need to be made to federal healthcare policies […]

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 […]

  In May, I wrote about how pharmaceutical companies were attempting to stop the FDA from banning the promotion of drugs for off-label uses. According to an Amarin press release issued on August 7, 2015, a United States District Court sided with the pharmaceutical company, saying that they “…may promote to healthcare professionals certain uses […]

  In case you missed the headlines in the last few days, the FDA issued a Warning Letter to Duchesnay over Kim Kardashian’s Instagram post promoting Diclegis, the pharmaceutical company’s drug for “the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management,” commonly known as morning sickness. 

  Naming drugs and medical devices is an art form that requires creativity, knowledge of linguistics, and an understanding of how to navigate the regulatory landscape. It’s easy to think of names, but coming up with ones that are meaningful and memorable, yet different enough than anything currently on the market, is another story. The International […]

  Is she online yet? Is he free or in a meeting? Ugh, how many times a day do you find yourself wondering whether your colleague is available for a chat? Relax. And quit checking your instant messenger (IM) every five seconds. With Skype for Business (formerly, Microsoft Lync), your needs are met by one […]

  Over the past few months, the life sciences practice has produced several free resources related to the 21 CFR Part 11 regulation that governs electronic records and electronic signatures. To make it easy for our industry colleagues to find those resources, we decided to create a single blog post that links to all of […]