The industry wide Signal detection challenge is to identify Drug Drug Interaction for a Serious Adverse Event. Well…. it is not that challenging when it is just Drug and Drug and an Event. The challenge comes if it is Drug Drug Drug Drug and Event and Lab value. Let us discuss in details…. in the…
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CRO was using InForm for Case processing. How to upload all InForm data in to Argus? Any thoughts?….
Non-Interventional Study = Medicinal product is prescribed in the usual manner (Example: Acetaminophen only) Interventional Study = Participants are assigned to receive one or more interventions so that researchers can evaluate the effects of the interventions. (Study medication (Acetaminophen ) with Cantaloupe juice and Aspirin)
Commonly used abbreviations in Pharmaceutical Industry ACRO Academic Research Organization CDMoP Clinical Data Monitoring Plan CRA Contract Research Associate CRO Contract Research Organization CSR Clinical Study Report CTTI Clinical Trials Transformation Initiative DM Data Manager DMon Data Monitoring – All raw and source data review activities by a sponsor that guarantee the protection of trial…
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What is BI Publisher? Its a component of OBIEE (Oracle Business Intelligence Enterprise Edition) where a developer can create a layout (just the layout) for complex-layout report. Examples: The following report has two totals at the bottom. This is simple, why to use BI publisher for it? Well, its just an example of Row-level columns.…
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What is Argus Analytic? Its a reporting environment for Argus safety application. Oracle integrated the OBIEE (Oracle Business Intelligence Enterprise Edition) an Oracle report development tool with Argus application for reports creating and publishing. Drag and drop User interface lets the User choose the column needed to build a simple report. Complex reports (meaning the output…
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Empirica Signal and Topics: Long topic… in a nutshell, use “Empirica Signal and Topics” application (hosted by Oracle) to find Safety Signal in the FDA’s AERS data and WHO Vigibase data. Create a topic (Example. To find “fabriel neutropenia” in Oncology_Drug_1) Search for Signals Track the signal Share the signal with your group for review and comments.…
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JReport – A Business Intelligence Visualization Tool
What is NOS in MedDRA Preferred Terms? Why do they use it? Example: Abdominal hernia NOS Abdominal hernia NOS gangrenous Abdominal hernia NOS, obstructive Blood alkaline phosphatase NOS Blood alkaline phosphatase NOS abnormal Blood alkaline phosphatase NOS decreased Blood alkaline phosphatase NOS increased Blood alkaline phosphatase NOS normal Why do they do it?
End Point: Phase 1 Primary End Point is Safety Phase 2 End Point is Efficacy Phase 3 End Point is Efficacy with fewer Mortality. Phase 4 End Point is Efficacy – Post-Marketing or Spontaneous reports. Baseline: Coming up….