Home page
Company Info Services Our products Publiccation Associations
CDISC Services

CDISC Data Standards Implementation

  • Transform Existing Data to CDISC SDTM Data Models.
  • Verify and Validate Data for Compliance to Data Standards.
  • Manage Metadata of All Standards for Future Implementations.
  • Generate Data Definition Documentation in DEFINE.XML and DEFINE.PDF.
  • Generate Annotated CRF with New CDISC Variables.

CDISC Services

Data standards can make data and its associated programs more portable. Team members working with these standards work more collaboratively and become more efficient. This makes the development and validation of SAS? programs within a regulated environment much more efficient. Meta-Xceed's CDISC service provides your team with expertise on the latest CDISC Submission Data Model. This allows you to submit your data in the proper standards and be fully compliant.

CDISC Compliance and Data Integrity Service 

  • Analyze existing data with CDISC standards
  • Establish and apply data transformation to CDISC standards
  • Evaluate data integrity before and after CDISC models
  • Maintain standards among existing data structures
  • Reconcile interpretations of CDISC standards
  • Generate validated code to perform transformation to CDISC

Prepare Electronic Submission Documentation

  • Capture all metadata for submission data
  • Generate domain documentation (define.pdf) in both PDF and XML formats
  • Maintain updates to documentation as data changes with change control

Data Standards and CDISC Tools Suite
MXI offers comprehensive set of tools for Data Standardization which works effectively with your clinical data analysis/reporting and submission processes. The tools provide you with efficient methods to become compliant with regulatory requirements. This automates the process and delivers data with greater accuracy and integrity.

  • Sy/Validate - User friendly tools for performing validation and change control of SAS programs.
  • Transdata  - Transdata can be used to efficiently transform your SAS data into standards.
  • CDISC Builder - CDISC Builder is a suite of tools which optimize the creation of your CDISC submission datasets.
  • Definedoc  - Definedoc contains macros and interactive tools which automate the process of documenting your electronic submission datasets.
  • CDISC Reports  - Generate validated code from a library of standard safety summary and listing upon CDISC SDTM and ADaM datasets.



For more information, please contact MXI .

     Meta-Xceed Inc. © 2016
Bookmark and Share
Meta-Xceed, Inc. - SAS Consulting, SAS Alliance Partner, Clinical Analytic Software Solutions, SAS Biotech Pharmaceutical Consulting, CDISC Services, CDISC Compliance and Data Integrity Service, Electronic Submission Documentation, SAS System Validation

Clinical Analytic Software Solutions SAS Consulting SAS Alliance Partner SAS CFR Part 11 Compliance SAS Software Development SAS Biotech Pharmaceutical Consulting SAS Biotech Pharmaceutical Consulting SAS Consulting SAS Alliance Partner Clinical Analytic Software Solutions SAS Biotech Pharmaceutical Consulting Clinical Analytic Software Solutions CFR Part 11 Compliance SAS Alliance Partner SAS Software Development SAS Biotech Pharmaceutical Consulting SAS Data Standards SAS Data Quality SAS Data Integrity SAS Data Audit SAS Data Versioning CDISC Data Standards SAS Data Transfer Utility SAS Data Conversion Utility Clinical Analytic Software Solutions Adverse Event Data Coding Adverse Event Data Mapping Adverse Event Auto Coder Adverse Event Autocoder MedDRA Coder MedDRA Autocoder MedDRA Auto Coder Costart Coder Costart Autocoder Costart Auto Coder Who Drug Coder Who Drug Autocoder Who Drug Auto Coder SAS Analysis Tools SAS Reporting Tools SAS Batch Submit SAS Report Standards SAS Log Evaluation SAS Page X of Y Tool Table of Contents SAS Output SAS Output TOC SAS Code Development SAS Development Environment SAS Macros Management SAS Output Management SAS Output TOC First Page SAS Output SAS Log Runtime SAS Program Search and Replace Tool SAS Program Validation SAS Program Validate SAS Program Audit Trail SAS Program Versioning SAS Program Version Control SAS Program Change Control SAS Program Verification SAS Program CFR Part 11 Compliant SAS Data Standards Scheduling of SAS Jobs SAS Clinical Information Management SAS Web-based Clinical Information SAS ESUB FDA Submission

SAS Benchmark SAS System Benchmark SAS Software Benchmark SAS Performance SAS Performance Benchmark SAS Performance Test

SAS Cluster SAS Grid Cluster SAS Grid SAS SAS Cluster System SAS Cluster Servers SAS Grid Computing SAS Plugin for MS Office SAS MS Office Plugin SAS Plugin for Excel SAS Plugin for MS Word SAS Excel SAS MS Word SAS Macro Interfeace for MS Office Optimize Report Generation from CDISC Standards Generate Reports from CDISC Data SDTM Reports ADaM Reports Standard SAS Reports SAS Program Library SAS Macro Library CDISC Course CDISC Class SDTM Course SDTM Class CDISC Training CDISC Implementation Training CDISC Implementation Class MedDRA Training MedDRA Class WHO Drug Training WHO Drug Class AE Coding Training AE Coding Class Drug Coding Class Drug Coding Training DEFINE.PDF Training DEFINE .XML Training Domain Documentation Training Domain Documentation Class Data Definition Training Data Definition Class SAS Validation Training SAS Validation Class SAS System Validation Training SAS System Validation Class SAS Program Validation Training SAS Program Validation Class SAS Macro Training SAS Macro Class User Friendly SAS Macro Course User Friendly SAS Macro Training Programming Macro Training Programming Macro Class SAS Excel Course SAS Excel Training SAS MSOffice Course SAS MSOffice Training SAS MSWord Training SAS MSWord Course Change Control Training SAS Change Control Training SAS Program Change Control Training SAS Macro Change Control Training SAS Change Control Class SAS Program Change Control Class MedDRA Coding WHO Drug Coding MedDRA Coding Service WHO Drug Coding Service MedDRA Service WHO Drug Service Thesaurus Dictionary Management ADaM ADaM Consulting ADaM Service Analysis Datasets Analysis Datasets Consulting Analysis Datasets Service Annotated Case Report Form Annotated Case Report Form Consulting Annotated Case Report Form Service Annotated CRF Annotated CRF Consulting Annotated CRF Service Biostatistics Consulting Biostatistics Service CDISC ADAM CDISC ADAM Consulting CDISC ADAM Service CDISC Compliance CDISC Compliance Consulting CDISC Compliance Service CDISC SDTM CDISC SDTM Consulting CDISC SDTM Service Clinical Data Management Clinical Data Management Consulting Clinical Data Management Service CRF Design CRF Design Consulting CRF Design Service Data Management Service Design Case Report Form Design Case Report Form Consulting Design Case Report Form Service Discrepancy Management Discrepancy Management Consulting Discrepancy Management Service Edit Checks Edit Checks Consulting Edit Checks Service Electronic Submission Electronic Submission Consulting Electronic Submission Service SAS Consulting SAS Development Consulting SAS Development Service SAS Program Consulting SAS Program Service SAS Service SDTM Consulting SDTM Service Statistical Consulting Statistical Service Tables Listings and Graphs Tables Listings and Graphs Consulting Tables Listings and Graphs Service TLG Consulting TLG Service Coding Methodologies Contract Research Organizations CRO Data Library Managing Thesaurus Reconciling Dictionaries SAS Macros Table of Contents TOC Biostatistics Case Report Form Case Report Form Design Case Report Form Service CFR part 11 Clinical Data Management CRF Tabulations Custom Database Custom Database Consult Custom Database Design Custom Database Service Data Analysis Data Management Data Warehouse Design Clinical Plans Electronic case report Electronic submission FDA Submission IND Medical Device System Validation Ndas Prepare Patient Profile Consult Patient Profile Generator Patient Profile Service RFP SAS Consulting SAS Service SOP Consulting SOP Service Code Optimizer Data Models Data Standards Data Definition Define.xml Define.PDF Domain documentation Data Definition Documentation Coded Terminology Coded Terminology Management Coded Terminology Software SAS Format SAS Format Management CDISC Coded Terminology Coded Terms Coded Terms Coded Terms Software Controlled Terminology Control Terminology Controlled Terminology Management Control Terminology Management Control Terminology Software Controlled Terminology Software CDISC Controlled Terminology CDISC Control Terminology SAS Data Viewer Data Viewer Syview View SAS without lock SAS Dataset Viewer SAS Dataset View SAS Data View Optimize Report Generation from CDISC Standards Generate Reports from CDISC Data SDTM Reports ADaM Reports Standard SAS Reports SAS Program Library SAS Macro Library Extracting Oracle to SAS Configuring SAS/Access to Oracle Configuring Connection to Oracle Clinical Verify Environment Variables Verify Connection to Oracle. Assign SAS Dataset Labels Sort SAS Extract Annotate Case Report Form Batch Extract Views Validate Oracle Extract Extract OC OC Extract Views OCL Extract SAS Extracts