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CLINICAL ANALYTIC SOFTWARE SOLUTIONS SAS SOFTWARE DEVELOPMENT AND CONSULTING BIOTECH PHARMACEUTICAL EXPERTISE SAS CFR PART 11 COMPLIANCE EFFECIENCY  ACCURACY EXPEDIENCY
Services
 

Meta-Xceed has a highly skilled and experienced team providing clients with support from phase 1 through the regulatory submission process. We have expertise in statistical programming, biostatistics, data management, medical writing and project management. Our services can be accompanied by our own software or we can develop customized solutions based upon the client's requirements.

We specialize in services in the areas of: SAS Consulting, SAS Validation, CDISC Standards, CDISC SDTM and CDISC Training.

   

CDISC Services

  • SDTM Transformation from Legacy and Operational Data Structures
  • ADaM Implementation
  • CDISC Compliance and Data Integrity Service
  • Prepare Electronic Submission Documentation (define.pdf).
  • Perform Systems Validation

SAS Programming

  • Tables, Listings and Graphs
  • Analysis Datasets
  • Validation of SAS Programs
  • Patient Profiles and CRF Tabulations
   

Biostatistics

  • Develop Statistical Analysis Plans
  • Statistical Review of Tables, Listings and Graphs
  • Produce Statistical Reports
  • Represent Client at FDA Meetings
  • Write Statistical Methods for Protocols
  • Plan and Develop Protocols
  • Design and Develop Clinical Plans

System Validation

  • Write Study Reports
  • Prepare NDAs
  • Produce Protocols
  • Generate Manuscripts
  • Provide IND Updates
  • Write SOPs
 
   

Project Management

  • Manage the CRO Process
  • Manage Budget, Timelines, and Deliverables
  • Produce RFP and Review Bids

Data Management

  • Design Case Report Forms
  • Design Custom Databases
  • Perform Data Entry
  • Manage Discrepancies
  • Provide Electronic Case Report Form Review
  • Generate Monitoring and Status Reports
  • Deliver Data in CDISC Models
   
     Meta-Xceed Inc. © 2006
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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