Access to CDISC foundational standards metadata as library
Rich programmer utilities including standard directory tree / storage locations and programmer utilities for troubleshooting, review and quality checks
EG/ SDD/ LSAF
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MetaTransform- Data Transformation Engine
Our Solution
Standardized approach to generate data transfer specifications, data flow and data sets based on source and target data states and mapping of metadata
Data states can be any relational data including CDASH, SDTM, and ADaM
Define.xml is defined right at the beginning to avoid issues down the line
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MetaStands- Standards Management Module
Our Solution
Concise & adequate metadata design to support operational efficiency for managing data standards across studies, therapeutic areas
Legacy data conversion
Comparisons between studies, study to standard, versions of standards, initial to final study data spec., etc
Access to CDISC foundation standards metadata as library
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MetaNymous- Data Anonymization Module
Our Solution
Deidentifies data at multiple levels using the metadata design to meet regulatory requirements, making the data available while protecting the privacy of study subjects
Consistent anonymizations across data states such as SDTM and ADaM
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MetaReports- Statistical Reporting Module
Double programming spaghetti code approach is always time consuming and involved significant manual verification and inconsistencies between SAP, shells and outputs.
Our Solution
Assists in creating tables and listings. Focused on titles and footnotes at this time
Can be customized to build sponsor based TFL shells
Title / Footnote storage and automation to reports
E3 Structure and Content of Clinical Study Reports COMPLIANCE
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MetaDefine- Regulatory Submission Module
Our Solution
Create programming-related deliverables for eCTD submissions, including define.xml schema version 2 and SAS transport files
Enhanced define in html format for submission as printable define
STUDY DATA TECHNICAL CONFORMANCE GUIDE COMPLIANCE
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