Regulatory Compliance

I don’t often see FDA Warning Letters issued to Institutional Review Boards (IRBs), so, when I came across this one, I thought it was worth sharing with you. This particular IRB was found to be in violation of 21 CFR Part 56.115(a)(2), related to meeting minutes, and 21 CFR Part 56.115(a)(5), related to a complete […]

I enjoy reading FDA Warning Letters. They’re insightful and often entertaining. Sometimes, though, they’re kind of unbelievable. And, sometimes, they’re downright nauseating. Take, for example, this letter issued on February 19, 2016 to a principal investigator (PI) based in New York. FDA inspectors found him to be in violation of 21 CFR Part 312.62(b), related […]

  In a time when the turnover rate for clinical monitoring positions in the U.S. hovers around 25%, it’s more important than ever to do more with less. With risk-based monitoring (RBM), contract research organizations (CROs) and sponsors can leverage data in existing IT systems to spot, rectify, and prevent issues related to the execution […]

  Real-world data, the data generated about drugs and devices in real-world settings (e.g., routing doctor visits, hospital stays, etc.), can help develop more accurate product profiles. This is because the data comes from products that are no longer confined to the smaller, homogenous populations involved in clinical trials. More comprehensive profiles can help better […]

  Oracle’s third quarter 2016 earnings call was peppered with strong revenues and big wins in various categories. But what was most striking was the incredible progress the enterprise software powerhouse has made with regard to the cloud. Between CEO Safra Catz, CEO Mark Hurd (yes, they’re both CEOs), and Executive Chairman of the Board […]

  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 April 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 March – they’re ranked in order of popularity, with number one being the most viewed piece. 

  On January 8, 2016, the FDA issued a warning letter that caught my attention. I can’t remember why I initially opened it; maybe because the company’s name had “pharm” in it, as opposed to “seafood” (which seems to be there a lot!). Once inside the letter, I found this in the opening paragraph: “This […]

  On January 14, 2016, Perficient hosted a webinar titled Leveraging Siebel CTMS for Risk-Based Monitoring. We received some good questions during the webinar and figured we’d share them (and the answers) with you. 

  It’s that time of year again. The event for industry thought leaders and decision makers is just around the corner, and we’re hoping you’ll attend. Even if you can’t attend, we’re still giving you the opportunity to enter to win a SONOS wireless speaker…just because we like you. 

  Dr. Robert Califf, a cardiologist who has spent most of his career at Duke University, was confirmed by the Senate on February 24, 2016, to be the next FDA commissioner, following President Barack Obama’s nomination in September 2015. 

With the continued move towards digital securing patient data has moved to the top of the list for many healthcare organizations. I sat down with David Chou (@dchou1107) to talk about data and device privacy and security and get his perspective on the challenges and what organizations can be doing to protect themselves and their […]