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Clinical Data Management &
Biostatistics
CDM tool:
Data management
runs on internationally approved and validated CDMS, SAS Pheedit
3.0 which undergoes exhaustive quality control testing and
quality assurance oversight from CRF design through database
lock.
CDM
services,
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Protocol
design and review
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Case Report
Form (CRF) design, review and production.
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Database
design
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Data entry
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Data
validation/verification
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Medical
review.
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Medical term
coding.
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Lab Data
transformation from non-central Laboratories.
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Quality
management procedures
Biostatistics services,
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Design,
Randomization, Sample size calculation
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Data
manipulation
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Statistical
Analysis
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Periodic data
monitoring and safety reviews (DSMB)
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Unscheduled
interim analyses
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Post-hoc and
exploratory analyses
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Formal interim
and final analyses
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Statistical
consulting
CDM
Infrastructure,
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A robust IT
infrastructure is in place to ensure complete accountability
of the data being processed with validated 24 × 7 physical and
data security, redundant power and internet connectivity
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Dedicated IT and DBA support
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Data backup and Disaster recovery policy.
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SAS Pheedit 3.0
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SAS 9.1.3 for Data Analysis
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Business Object (Crystal reports) 11.0 for CDM reporting
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WinNonlin® 5.2,Kinetica 4.4.1 for Pharmacokinetic Analysis
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MedDRA for Medical coding
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WHODD for drug coding
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