Posts Tagged ‘drug safety’

Pharmacovigilance

Pharmacovigilance During COVID-19: Finding the Best Information

There is no question that the pandemic COVID-19 has transformed life as we know it today. We are now operating in a different pharmacovigilance (PV) paradigm, adapting as we move daily. While patient safety remains the first priority, AEs will continue to come in for processing, and daily PV activities will continue. New therapeutic information […]

pharmacovigilance

22 Reasons To Attend Thursday’s Pharmacovigilance Surveillance Webinar

The challenge with all pharmacovigilance and safety surveillance is that it’s quite complicated. There is a lot of data and very few technical solutions that make analyzing safety data relatively simple. That’s where Perficient comes in. Join me, Kari Blaho-Owens, Ph.D., Director of Pharmacovigilance and Safety, Perficient, on February 6, 2020, at 10 AM CT, […]

Join Us At Oracle Industry Connect 2018

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 […]

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 […]

Post-Market Surveillance Of Drug Safety

This is the final post in our brief series on drug safety. If you missed any of the previous posts, here are the links: Why Monitoring Adverse Events And Drug Safety Signals Matters What Exactly Is An “Adverse Drug Reaction?” The Role Of Signal Detection In Drug Safety What Pharmacovigilance Means And Why It Matters […]

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