Overview

Biostatistics, Data Management, and Regulatory Publishing

VIMTA is committed to enhance data quality through best data management support systems and an integrated approach to prepare eCTD and CDISC implementation for smooth regulatory submission procedures

Services

Our BSDM services and activities include

Sample size estimation for PK and therapeutic end point studies
Generation of randomization schedules for varied study designs
Pharmacokinetic and statistical analysis of data for PK and In-VitroBE studies using SAS
Handling data for average bioequivalence, reference scaling approaches and other customized designs
Compilation of reports and compliance with ICH requirements
eCTD compilation and publishing using TRS toolbox 6.3 Pharma
Preparation of CDISC compliant data sets
Annotated CRFs
SDTM datasets with validation
ADaM datasets with validation
Reviewers guides for SDTM and ADaM
xmls for SDTM and ADaM