Posts Tagged ‘clinical trials’

The electronic transmission of adverse event information to stakeholders, using the International Conference on Harmonisation “E2B” standard, is an essential component of global drug safety and pharmacovigilance operations. E2B(R3), the latest version of the International Standards Organization (ISO) Individual Case Safety Report (ICSR) standard, includes new requirements with which product manufacturers and the organizations that […]

In September, leaders from Pfizer, Otsuka, Quintiles, Roche and Eli Lilly & Co. to name a few, will be convening at the ‘Mobile in Clinical Trials’ event in Boston to discuss the uses and barriers to mobile technology in clinical trials. Mobile and web-based technology platforms are on the rise for clinical trials and post-approval […]

Then we’ve got a special webinar, just for you. On July 21, we will be having a fireside chat with our client, Alliance Foundation Trials (AFT), a research organization that develops and conducts cancer clinical trials. The chat will include a few presentation slides, so that you’re not looking at a blank screen, but much […]

There’s been a lot of talk recently about SharePoint 2016. This latest version is especially appealing to life sciences companies because it supports the flexibility of a hybrid on-site/cloud implementation. That means that organizations who aren’t quite ready to fully embrace the cloud have the power to host certain features in-house behind their firewall and […]

Now that June 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 May – they’re ranked in order of popularity, with number one being the most viewed piece. Gartner’s List Of 5 Cool Vendors […]

We’ve talked a lot in this blog about the use of electronic health records (EHRs) in clinical trials. Recently, my colleague wrote about it on our healthcare blog, so, I thought I would share her post with my pharma and CRO friends. While our previous posts focused on the use of EHR for subject recruitment […]

The Food and Drug Administration has issued a draft guidance stating that in order to see the highest success, clinical trial leaders must use electronic health records (EHR) that promote health data interoperability. In the draft guidance entitled Use of Electronic Health Record Data in Clinical Investigations, the FDA indicated that health data interoperability may […]

The deployment of business process management (BPM) strategies in a digital world revolves heavily around leveraging software platforms to automate pieces of or even complete processes. Whether you’re in clinical operations, safety and pharmacovigilance, or a back-office department, BPM technology solutions can be used to address virtually any business challenge that involves a process. Join […]

If there’s one list that gets a lot of touch attention in life sciences, it’s Gartner’s Cool Vendors in Life Sciences. While the name of the list helps grab attention on its own, the companies it features are typically just as interesting. This year’s list happens to carry a few companies that we’ve blogged about, […]

Now that May 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 April – they’re ranked in order of popularity, with number one being the most viewed piece. From Laptops To Tablets: Eli Lilly Bought […]

If you’re an avid reader of this blog, you’ve probably seen several posts highlighting Quintiles, the world’s largest contract research organization (CRO). That’s for good reason. Not only is the global CRO at the top of its game, when it comes to running all aspects of clinical trials for their clients, they’re leading the way […]

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 […]