The RxView Blog

July 11, 2029 Wednesday - 9:01 AM. The Tech-Com Human Resistance succeeds in destroying Skynet's defensive grid located in Colorado, USA. The Skynet mainframe is breached by Resistance soldiers, and Skynet is deactivated, finally ending the War of the Machines and returning domain of planet Earth to humankind.

Perhaps, because I grew up on Terminator movies, the year 2020 feels like the future to me. It was 2029 when Skynet collapsed and here we are only nine short years away! Using Terminator math, the case processing AI is already turning on the human pharmacovigilantes and throwing the world of drug safety into a fight for its very existence!

Luckily for all of us, the War of the PV Machines is the stuff of science fiction.  However, the conflict, or more specifically the friction that exists within pharmacovigilance is at the top of our minds here at Advera Health.

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#5: How to Replicate a Clinical Meta-Analysis Study in Evidex

 

Overview: 

Traditionally, safety related meta-analyses have been costly, taken significant time to produce and can often miss relevant studies. Further, there has been no efficient way to test the outcome of those studies prior to initiation. This has led to a lot of unnecessarily wasted resources. 

Luckily, Advera Health with the help of machine learning, artificial intelligence, and data science is solving this problem for drug safety, epidemiology, and medical affairs departments of all sizes. 

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Thanks to everyone on the great feedback we have received on this blog series focused on pharmacovigilance best practices for clinical and early post-approval biopharma companies. We've discussed discussed the importance of understanding reporting and submission to FDA, taking control of your pharmacovigilance software and creating a shared services model with your CRO.

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Last week's blog post discussed the importance of taking control of your pharmacovigilance software. This week we discuss Best Practice #3: Using software to create a shared services model with your CRO.

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Last week's blog post discussed the importance of understanding what adverse events are reportable to FDA and how they are submitted. This week we discuss Best Practice #2: Take control of your software. 

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Last week's blog post introduced our new pharmacovigilance "best practices" series that we have put forward for clinical and early stage biopharma companies. This week we discuss Best Practice #1: Understand what is reportable and know how reports are submitted to FDA. 

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The idea of selecting, implementing, and deploying pharmacovigilance software is overwhelming for smaller companies. At larger pharma companies, teams of people, vendors, and consultants are dedicated to  implement the software and keep it running. Smaller clinical and early post-approval stage biopharma companies have to make do with significantly fewer resources and they are understandably quick to look for outside help.

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Traditionally, safety related meta-analyses have been costly, taken significant time to produce and can often miss relevant studies. Further, there has been no efficient way to test the outcome of those studies prior to initiation. This has led to a lot of unnecessarily wasted resources. 

Luckily, Advera Health with the help of machine learning, artificial intelligence, and data science is solving this problem for drug safety, epidemiology, and medical affairs departments of all sizes. 

Last week we announced the launch of Clinical Meta-Analysis in Evidex capability and we have provided a walkthrough with screen shots is below. This new analytical tool provides the capability to perform meta-analyses of safety issues using a cloud-based software-as-a-service platform.

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Since Salesforce ushered in the age of software-as-a-service (SaaS) 19 years ago, the market for software has changed dramatically, as have the products that companies have brought to market. 

The SaaS model has become so commonplace that even Salesforce itself had to clarify back in 2015 that “No Software” really meant, “No legacy software, just cloud software.” SaaS and software are now synonymous, in all but a few cases. Pharmacovigilance software is one of those few cases.

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