MetaVate | Algorics

Why MetaVate?

End to end transparency in data flow from CDASH through SDTM, ADaM and associated TFLs.

Gain atleast 50% efficiency on data transformation & submission.

Plug & Play engine to achieve modular or end to end automation.

MetaExec MetaTransform MetaStands MetaNymous MetaReports MetaDefine

MetaVate is a fully integrated modular solution with a unique, metadata-driven data transformation engine designed to support the creation of any target data sets from any source data sets, including SDTM, ADaM and third-party data. This platform can be utilized by data-mapping specialists, increasing the efficiency of statistical programmers to focus on more complex tasks. MetaVate’s architecture is built to complement any existing infrastructure investments, and is agnostic to operating systems, versions of statistical software, and metadata repositories.

With MetaVate, we believe the complete spectrum of statistical programming will be transformed thus increasing efficiencies exponentially.

MetaExec- Statistical Computing Environment

The current clinical technology environment poses limitations in business workflows for automation, information availability and access. Most technology solutions are working in silos to solve different organizational problems but are not sustainable or scalable.

Our Solution

Establishes a standard SAS execution environment
Scripting across platforms
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

Typically, approaches for transforming different data states can be diffused and scattered. ADaM transformation is challenging due to study level derivations and Define.xml which is seen as the last step, is prone to data structure errors.

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

Studies built over time have different metadata design and hence add complexities for cross study analysis, data aggregation and operational inefficiencies

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

Through clinical development, deidentification and anonymization of individual patient data as per regulatory requirements and at the same time safeguarding data privacy of trial participants, has been a consistent challenge.

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

The manual arrangement of multiple metadata definitions (SDTM, ADAM, ARM) in Define-XML is highly time consuming and inefficient.

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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