Life Sciences

  This is fascinating on many levels. On July 31, 2015, the FDA has approved – for the first time in history – a drug that is developed on a 3-D printer. Not a medical device or a toy figurine; a drug. Aprecia Pharmaceuticals is the maker of SPRITAM, which is designed to treat seizures […]

  Over time, the concept of Quality Control has evolved to become Total Quality Management (TQM). According to Wikipedia, the concept of TQM “…consists of organization-wide efforts to install and make a permanent climate in which an organization continuously improves its ability to deliver high-quality products and services to customers.” Since a CAPA system is […]

  Ed Miseta, Chief Editor of Clinical Leader, recently interviewed Mike McKay, Associate Director of Operational Excellence for Shire Pharmaceuticals, on his view of the clinical IT space and how it’s affecting his company. Here are several takeaways from his interview: 

  Let’s face it, anything with “99+” in the title is catchy. That’s why we used it for our upcoming 99+ Siebel CTMS Best Practices You Should Follow webinar. We wanted you to know how content-rich the webinar will be, whether you’re a current user of Oracle’s clinical trial management system (CTMS) or in the […]

  Let’s face it: Keeping clinical trials on schedule is not easy to do. Whether a sponsor runs into issues with quality, timeline, personnel, or myriad other things with an outsourced partner, it’s crucial to address the problems as soon as they’re identified. There are a few routes a sponsor can take when a study […]

  I’m sitting at my desk thinking to myself: Why don’t I see many ads trying to recruit patients for clinical trials? “Many” is actually an overstatement. I rarely see them. Anywhere. And that’s a problem. I’m fairly healthy, but I have some issues. I’m slowing balding. I suffer from heartburn. Sometimes, I have debilitating […]

  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 […]

  Perficient’s Life Sciences practice regularly monitors the software release notes for several Oracle Health Sciences applications, as well as our own clinical and safety systems. The systems covered in our review are: 

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

  One question we often get relates to disabling Oracle Clinical (OC) and Remote Data Capture (RDC) accounts. What happens to the OC/RDC accounts of users who separate from a company or roll off of a clinical trial? The answer is relatively simple, though not necessarily obvious, because the only way to tell if an […]

  While pharmaceutical companies are still trying to figure out whether they should partner with companion diagnostic makers, acquire them, or simply begin developing their own tests, one thing remains certain: companion diagnostics are here to stay. 

  There’s a lot of talk these days about digital transformation: changing the way companies interact with their constituents. In general, the movement has not focused on specific groups of people…until now.