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Statistical Services – Core Competencies
New Drug Application (NDA)
Statistical analysis
and statistical programming services for NDA and sNDA submissions (FDA)
Phase I through Phase IV Drug testing (Safety & Efficacy) for FDA
approval
Protocol Development and Protocol Review for Statistical Details
Generation of Statistical Analysis Plans (SAPs)
and Programming Specifications
Project Management and Generation of Tables, Listings & Graphs (TLGs)
Tools for e-Submission to FDA (including CDISC standards)
Tools for CDISC (Clinical Data Interchange Standards Consortium)
conversion of Legacy Studies
A suite of SAS Macros developed over several man years of experience
Health Economics &
Outcomes Research (HE&OR)
Proficient in
HE&OR studies and analysis methods –
ü
Resource Utilization
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Cost/Benefit Analysis
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Cost of Hospitalization/Procedures and Treatment Therapy
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Quality of Life
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Patient Reported Outcomes
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Drug Compliance and Drug Persistence (Drug Switches)
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Provide input to design of clinical trials mining large
scale databases
Expertise in processing large claims/survey databases –
ü
MarketScan (Thomson Reuters MedStat)
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i3 Data
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GPRD
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GE-EMR (Electronic Medical Records)
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NHANES Data (National Health & Nutrition Examination
Survey)
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NIS
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NHIS
Developed
a suite of macros in SAS and Packages/functions in S-Plus/R for Medical
Data Analytics using the above large claims/survey databases
Exploratory
Data Analysis (EDA) for Medical Affairs
Product Defense
Brand Development Activities include - Sales Aids, Marketing Messages etc.
Phase III-b and IV post-marketing support and label changes
Publication, Manuscript, Abstract and Poster Presentation Support
Pooled, subgroup and meta analyses on clinical trial data to help design
new clinical trials
Generation of SAPs
and Programming Specifications for EDA
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