Perficient is sponsoring Oracle Industry Connect April 10-11 in New York City, and we would like our valued clients to be there. Several key representatives from our life sciences practice will be available to discuss any of your ongoing or upcoming initiatives. Mike Grossman, General Manager Dennis Dougherty, Business Development Executive Rudolf Coetzee, Business Development […]
Posts Tagged ‘pharmacovigilance’
Interest In AI And Cognitive Is Rising In Pharma
Artificial intelligence (AI), cognitive computing, and machine learning are becoming more common in the industry. The need to scour and analyze large sets of data is giving life sciences companies new intelligence that would never have been realized before. The technology is making a big impact on healthcare decisions and patients. When it comes to […]
Building Better Safety Profiles With Real-World Data & Evidence
The use of real-world data has exploded in recent years and will continue playing a crucial role in 2018. Almost every major pharmaceutical and medical device company conducts real-world studies to build better safety profiles for their products, as well as support initial study findings. Real-world data can come from a variety of sources including […]
EMA Issues Brexit Guidance To Pharma
Pharmaceutical companies selling their products in the UK need to consider the impact Brexit will have on their operations. Some changes will need to be made before the UK leaves the European Union on March 30, 2019. In a press release, the European Medicines Agency (EMA) said: “The guidance document outlines the practical and simplified […]
Top 5 Pharma & Medical Device Blog Posts From October 2017
Now that November 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 October – they’re ranked in order of popularity, with number one being the most viewed piece. Aggregate Report Preparation In Safety […]
Aggregate Report Preparation In Safety And Pharmacovigilance
Aggregate report preparation represents one of the single most time- and resource-intensive pharmacovigilance regulatory requirements, which is why many companies are interested in more automated solutions that are fit-for-purpose. What we typically recommend to clients is a focused approach that optimizes as much as their internal workflow as possible. We also recommend that subject matter […]
FDA Ciphers Update: What To Consider If You Have Argus Safety
The FDA has decided that it will update the ciphers for their Electronic Submissions Gateway (ESG), but what does this mean for you? Here is the message that was received: FDA Electronic Submissions Gateway (ESG) will update ciphers and SSL protocols in Production on Saturday, January 20, 2018 at 9:00 PM EST. Please make sure […]
Argus Safety 8.1.1 – 2 Things To Know
Oracle Argus Safety 8.1.1 was officially released today, so I thought I would share a question that came up recently from a hosting customer. The customer asked us what the difference between Argus Safety 8.1 and 8.1.1 is. While there are your standard bug fixes and improvements, there are two significant changes that companies should […]
Top 5 Pharma & Medical Device Blog Posts From August 2017
Now that September 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 August – they’re ranked in order of popularity, with number one being the most viewed piece. What The FDA Requires Of […]
Top 5 Pharma & Medical Device Blog Posts From July 2017
Now that August 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 July – they’re ranked in order of popularity, with number one being the most viewed piece. All You Need To Know […]
What Pharmacovigilance Means And Why It Matters
Pharmacovigilance, or the practice of monitoring the effects of medicines after they have been released for commercial use, was expanded in 2002 by the World Health Organization (WHO) to include signal detection as a way of improving patient care and improving the overall health and safety of the general public. Today, pharmacovigilance activities should also […]
All You Need To Know About Oracle Argus Safety 8.1 In 30 Minutes
Hi everyone, it’s Indy here. For those of you who may not recognize my name, I’ve been helping lead our Argus Safety installations for the past few years. I wanted to drop a quick note to personally invite you to the webinar I’ll be presenting next week. It’ll be relatively short, by design, but it […]