A couple of weeks ago, a client of ours discovered a problem in the production (PROD) environment of one of their clinical systems. In the initial system implementation, they had opted for a single environment (without a sandbox, development, training, test, or validation environment), so they found themselves with no separate environment in which to […]
Posts Tagged ‘drug safety’
Canada’s New “Vanessa’s Law” Contains New Adverse Event Reporting Requirements
On November 6, 2014, Canada passed Vanessa’s Law, a new piece of legislation designed to protect patients from unsafe drugs and medical devices. The law comes after many complaints from citizens that the country wasn’t doing enough to oversee the safety of products sold in the marketplace or the clinical trials being conducted in the […]
Direct From The Pharmaceutical CEO To You The Consumer
What do our pharmaceutical product advertisements indicate about our national ideals, given the myriad of advertisements seen on the Internet, TV, in magazines, or heard on the radio here in the United States? Interestingly, the United States and New Zealand are the only developed nations that allow direct -to-consumer (DTC) advertising (Liang & Mackey, 2011). […]
Perficient’s Life Sciences Practice Lands On Fastest-Growing Bay Area Private Companies List
As 2014 comes to a close, a few last-minute accolades are being awarded. I recently wrote about BioPharm, a life sciences-focused IT consulting company that Perficient acquired in April 2014, being named to Inc. Magazine’s 5,000 fastest-growing private companies in the United States for 2014. Just yesterday, we received word that BioPharm was named to […]
Should You Be Afraid Of Ebola?
With the recent localized outbreak of Ebola in West Africa, much information and disinformation has made its way to the Internet and mainstreamed media outlets. Given the foggy haze of reality, I thought it would be helpful to publish a summary of important facts – as the science currently supports – about Ebola: how it […]
The One Feature CROs and AROs Love in Argus Safety
Oracle’s Argus Safety is a comprehensive safety and pharmacovigilance platform designed to enable pharmaceutical, biotechnology, and medical device companies, in addition to contract research organizations (CROs) and academic institutions (AROs) to focus on product safety and regulatory compliance. With the multi-tenancy feature in Argus Safety, CROs and AROs can provide services to multiple sponsors, while […]
To Hull and Back – What a Trip!
My recent trip to a new client in Hull, United Kingdom, reminded me of a Harvard Business Review management tip that is hard to argue. It conveyed three ways to start your client relationship right to ensure success: Make an accurate first impression. Make them feel comfortable, but also set clear expectations about what you can […]
Why We Love Signal Detection (And You Should, Too!)
The amount of time and money it takes for a drug or medical device to be developed and pushed to market is staggering and continues to grow. However, more often than not, once a product gets approved, the maker enjoys watching it flourish in the global marketplace for many years. Unfortunately, there are situations when […]
The Importance Of Interprofessional Education In Drug Safety
In recent years, we have seen many changes to the global “face” of product safety (FDA, 2009). Arguably, these changes modify the traditional focus of product safety from a case management and alert reporting strategy to include a more preventative, pharmacovigilance strategic focus. In order to successfully adopt these changes, it is critical that we […]
What It Means To Be #3633
Inc. magazine recently released its list of the 5,000 fastest-growing private companies in the United States for 2014, ranking companies by overall revenue growth over a three-year period. For the fifth year in a row, BioPharm Systems, a life sciences IT consulting company that Perficient acquired in April 2014, made the list. This accolade is […]