The Orbit Blog

Signal Management
Katherine Long

When Signal Management is the Answer to Signal Detection Challenges

The pharmacovigilance industry is locked in a race toward ever-more complicated signal detection algorithms. Cutting-edge technology like artificial intelligence, machine learning, and Big Data analytics is top-of-mind. While data science dominates the conversation, safety teams often overlook methods to optimize their approach to detection that do not require expensive data innovation programs. In this article,

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Periodic Reporting
Richard Long

Build-vs-Buy: How implementing a pre-configured PV Tracking solution will get you there faster

Most Pharma companies rely on passive tools—such as spreadsheets and email—for tracking and managing their Risk Management Plans (RMPs) and Additional Risk Minimization Measures (ARMMs). However, passive tools are inefficient. So, what can Pharma companies do to scale? The answer is: utilize modern technology strategies for managing these processes. However, the first decision they should

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Signal Management
Dan Feith

Tracking your Signals in EVDAS

So you found a potential safety signal in Eudravigilance EVDAS… now what? The EMA introduced and made available (to MAH’s and national competent authorities) the Eudravigilance Data Analysis System (EVDAS). This is great for companies and agencies who need advanced signal detection for post market surveillance. Included in EVDAS are tools to review case counts

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