Posts Tagged ‘drug safety’

  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 […]

  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. 

  In less than a month, Oracle will be hosting Oracle Health Sciences Connect Europe, a free event that is geared towards users of Oracle’s life sciences applications, as well as partners of the software company. The one-day meeting will take place on March 22, 2016, in London and will provide information on product roadmaps, […]

It’s not easy to sift through and make sense of the vast amount of data posted each day by patients or their caregivers via social media. When it comes to unstructured data (e.g., abbreviations and acronyms), it’s even more difficult. However, it’s critical to evaluate the constant chatter to help detect or prevent possible issues, […]

  Similar to many industries, but arguably one of the most challenging, the life sciences sphere undergoes regulatory and compliance changes. Each country, group of nations, and regulatory body proposes different guidelines at different times. And, even though it could take several years for the changes to go into effect, when they do, you’d better […]

  Patients who are being treated for diseases, such as cancer, often require multiple drugs to manage their conditions. For example, patients are often prescribed drugs that treat the actual disease, while others are meant to manage side effects from those drugs. Many of these patients can probably attest to inquiring about or doing their […]

  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 […]

  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 […]

  This is bizarre. It turns out that many doctors don’t know what the real, FDA-approved indications are for the medications they’re prescribing. In a Wall Street Journal article that discusses the risks of off-label uses for prescription drugs, the author cites a 2009 study of 1,199 physicians (mostly primary care doctors and psychiatrists) that […]

  Last week, I attended a webinar that showcased the results of a study on the adoption of clinical trial software in life sciences. The study was conducted by a working group led by the Tufts Center for the Study of Drug Development, CDISC, and Oracle Health Sciences, and the results reiterated what we already […]

  And that was just this past year. So, I think it’s fair to say that Oracle’s software is the cream of the crop in the life sciences and healthcare industries. According to a press release issued by the company, close to 100 life sciences companies have signed on to use Oracle’s clinical and safety […]