Eugene Sefanov

  If you have children, you know what it like is to give them a shot or any other type of medication. You also know what’s it’s like to take them to the doctor and have a “stranger” give them a simple checkup, let alone convince them to comply with more intrusive requests. That’s why […]

  A couple of weeks ago, I wrote about a warning letter that was issued to a pharmaceutical company last month. I highlighted one of the FDA’s findings, which had to do with the company’s standard operating procedures (SOPs) having an insufficient amount of detail about their process for collecting adverse events. Today, I want […]

  What do you do when the largest contract research organization (CRO) in the world agrees to appear in a video promoting several products? You watch, of course! Quintiles recently recorded a video that features the company’s president of clinical development discussing their use of Oracle Health Sciences solutions, such as Siebel Clinical Trial Management […]

  If you really think about it, it’s quite astonishing that Viagra sales in 2014 grew 47% in China, a country in which discussing sexual health-related topics has long been considered taboo. So, what caused this surge in sales?

  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. 

  Warnings letters stink, as they can impact a company’s image, stock value, and much more. That’s why companies should do everything in their power to make sure they follow FDA regulations to a “T.” 

  It’s not uncommon for sponsors and CROs to perform version upgrades on their clinical and safety systems or move away from certain ones altogether. They’ve been doing it for years. But why, when it impacts so many different parts of a company, both operationally and financially? The answer is relatively simple: Because what’s at […]

  The pharma industry undoubtedly gets a bad rap. “Drug companies charge too much.” “They are only in it for themselves.” And it goes on and on. But are these accusations truly justified? In a recent Forbes opinion piece, John Lechleiter, Chairman, President, and Chief Executive Officer of Eli Lilly, brilliantly debunks the more common […]

  I’m not going to get into whether prescribing or using drugs for off-label purposes makes sense – you can decide that for yourself. However, what I will tell you is that it’s a hot topic in the industry right now. Pharmaceutical companies continue to lobby the FDA to eliminate any prohibition of off-label promotion […]

  I recently stumbled upon the picture on the right on LinkedIn and it reminded me of a conversation that I had with my mother, who is an architect by trade. She told me that many roads came to be what they are today, not by well-thought-out plans, but rather by people and animals getting […]

  I have a thing for listening in on earnings calls, as I often hear interesting tidbits from executives about their businesses. On a recent call, I found it fascinating to hear the CEO of a biopharmaceutical company specifically address the progress they’re making on one of their clinical trials. He literally got down to […]

  A recent article that I read alluded to the fact that regulatory bodies are struggling to keep their websites updated, which could lead to misinformation or a lack of information for consumers and companies interested in a country’s regulations and policies. The story specifically pointed to the English and Korean versions of South Korea’s […]