Write SAP and TFL shell, power sample size calculation, randomization scheduling, statistical reviews of Data Management Plans (DMP) and electronic Case Report Forms (eCRFs).
aCRF annotation, SDTM domain and ADaM dataset specifications, SDTM mapping, ADaM data set generation, Independent validation of SDTM and ADaM datasets, Pinnacle 21 validation.
Staffing Stragety
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