MasterInnoMinds has gained extensive experience in clinical trails and reporting since we started offering contracted business for our clients in 2014. We prepare your data submission package so you can submit your data with confidence. We do also also verify whether CDISC-related submission documents created by other vendors satisfy the latest regulatory requirements. Submissing ready data pacakge services:

 

SDTM (Standard Data Tabulation Module) Package:

− SDTM datasets in xpt format - derived from CDASH/Raw data according to SDTM specifications 

− Annotated Case Report Form (aCRF)

− Define.xml - a data definition file describing structure and content of the dataset 

− Study Data Reviewer’s Guide (SDRG) - data description and conformance 

− Annotated Pinnacle 21 conformance report

− Additonal supporting documents

 

ADaM (Analysis Data Module) Package:

− ADaM datasets in xpt format - derived from SDTM according to Statistical Analysis Plan and ADaM specifications 

− Define.xml - describes format and derivation of analysis variables 

− Analysis Data Reviewer’s Guide (ADRG) - links between SDTM datasets, ADaM datasets and TFL in the clinical study report (CSR) 

− Program codes used to generate TFL from ADaM datasets

− Annotated Pinnacle 21 conformance report

− Additonal supporting documents