Regulatory Compliance

  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 […]

  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 […]

  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: 

  Several days ago, I wrote about how the life sciences industry, including government organizations, is struggling when it comes to the reporting of clinical trial results to the ClinicalTrials.gov database. Unfortunately, other issues plague the industry, including one that The New York Times reported on January 14, 2016. The Government Accountability Office (GAO) found […]

  The life sciences industry could learn a little something from Southwest Airlines’ “Transfarency” campaign, in terms of reporting clinical trial results. A recent investigation by the publication STAT found significant violations in the reporting of clinical trial results to the ClinicalTrials.gov database. Most academic research institutions, drug companies, and even the National Institutes of […]

  An interesting thing happened in pharma and investing. It involved Regeneron and their July 24, 2015 FDA-approved cholesterol drug, Praluent. Forbes outlined the situation, which caused Regeneron stock to drop significantly, in a January 6, 2016 article. According to Matthew Herper, a Forbes columnist, investors got a hold of data from the FDA’s Adverse […]

  Last week, I wrote that Vice President Joe Biden was going to meet with cancer researchers to talk about regulatory questions revolving around precision medicine. Today, we know much more about the cancer “moonshot” President Obama charged Biden with in this week’s State of the Union address. In a post on the publishing platform […]

  We’ve been getting a lot of requests, lately, to help companies decommission their old GxP systems. The systems were once validated and still contain GxP data that might someday need to be reviewed or analyzed, but they’re no longer being actively used. They’re just sitting there, taking up server space, undergoing basic IT maintenance, […]

  According to STAT, Vice President Joe Biden is meeting with over a dozen of the nation’s top cancer researchers today to talk about regulatory questions revolving around precision medicine. As you might recall, Biden’s son, Beau, recently died of brain cancer at the age of 46. 

  On December 17, 2015, the FDA issued a warning letter to Sun Pharmaceuticals Industries Ltd. in Gujarat, India. Sun Pharma’s website boasts that it is the “World’s 5th Largest Specialty Generic Pharmaceutical Company” with over 2,000 products in more than 150 markets across the globe. When an organization that large winds up with a […]