slides - Spatial Database Group

Database Design for Clinical Trial
Xiaoqing He & Gilsinia Lopez
Build an essential online resource for
tracking side effects of $1 trillion worth
of prescription meds sold around the
 Applications for both healthcare
professionals and patients
 Increase transparency throughout the
healthcare and pharmaceutical industries
Current status
75 % data capture – paper based
 Data inconsistencies
 Data Entry error
 Only 10 percent of data are reported
Electronic data capture – eCRF
Problems with eCRF
 Filled with misspelling
 Misclassification
 Out of date
Adverse Events Inc. (RxFilter ™)
RxFilter – 17 step data normalization
 Normalizes the FDA’s adverse events
reports into a single report, and
standardizes the data for improved
accuracy of adverse drug event
Achievements and Claims of
Adverse Events Inc.
Lamictal and Keppra, which are classified as
may be “as dangerous to a fetus as drugs
currently listed” should be placed in a more
risky category
measure medication side effects and
ensure high quality standards to protect
patient safety
 supports companies with competitive
intelligence and data to inform drug
marketing decisions and business
development strategies.
Relationship With Course
Relevant to chapters of Conceptual modeling
and Relational Database Design
 Data collecting, Standardizes and Normalizes
the data
 Basic of Functional Dependencies and
[1]Luke Timmerman, Biotech, Startups, IT, Sep. 2011,
[2]Business Wire, Sep. 2011,
[3]Picture 3-6 is from
[4]Picture 1 is from
[5]Picture 2 is from

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