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 […]
Posts Tagged ‘pharmacovigilance’
Researchers Are Scouring EHR And FAERS Data For Safety Signals
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 […]
FDA Reprimanded For Poor Tracking Of Post-Market Safety Data
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 […]
3 BI And Analytics Trends That Are Hard To Deny
According to IBM, we generate 2.5 quintillion bytes of data every day. And, 90% of the data that exists today, whether found in your clinical systems, on social media, or on your mobile devices, has been gathered within the last two years. All of that is what we call “big data.” As the volume […]
How Bad Data In FAERS Wreaked Havoc On Regeneron
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 […]
Good Chance Your Doctor Doesn’t Know Your Med’s Real Indication
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 […]
FDA Wants To Hear About Innovative Technology In Clinical Trials
Over the last decade, the life sciences industry has gone from running clinical trials on paper or, in many cases, in Excel, to leveraging comprehensive web-based systems, such as electronic data capture (EDC) and clinical trial management systems (CTMS). But, in more recent years, the widespread use of mobile technology has enabled even more […]
Study Confirms Use Of Clinical Systems Has Increased
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 […]
93 More Companies Chose Oracle Health Sciences Solutions
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 […]
The Troubles With Adverse Event Reporting
According to the September/October edition of the Impact Report released by the Tufts Center for the Study of Drug Development (CSDD), the reporting of adverse events (AEs) by healthcare professionals is inadequate. In particular, regulatory submissions are an issue due to the lack of critical information provided on submission forms, which can inadvertently alter […]
Why Clinical Trial Data Isn’t Enough
Life sciences organizations are in the business of developing drugs and medical devices. Hitting key milestones and moving trials to the next phase has always been a priority. Throughout this entire process, the collection and analysis of clinical and safety data is essential in taking products to subsequent stages, and ultimately getting them approved […]
What Are CAPAs And Why Are They Important?
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 […]