DIEM Computing Services, Inc.

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Statistical Consulting, SAS Program Development and Data Standards Implementation
Welcome
This site offers you the opportunity to learn more about DIEM Computing Services, Inc. Established in 1999, DIEM provides professional services in statistical consulting, data analysis, implementation of data standards, project management, and process documentation. DIEM is now a member of PharmaStat, LLC.
Services

Study Design and Set-up

Statistical Analysis and SAS Programming

Data Standards Implementation

Project Management

Process Documentation

Medical Coding and Reporting


Study Design and Set-up
  • Support in clinical development plans and individual study protocols
  • Advise on clinical trial study design and protocol development
  • Sample size estimations and power calculations
  • Protocol input and statistical sections
  • Write randomization plans
  • Generate subject randomization lists and emergency unblinding envelopes

Statistical Analysis and SAS Programming
  • Write comprehensive statistical analysis plans (SAP) for Phases I through IV clinical trials
  • Summarize data including customized data displays
  • Develop SAS programs for summary tables, figures and listings. Statistical analyses include preparations for Biologics License Application (BLA), New Drug Application (NDA), or Pre-Market Application (PMA) and updates of Investigational New Drug (IND). Other statistical analyses include pharmacokinetics, dose response relationships, bioavailability, animal studies, decision rules, discovery projects, screening bioassay analysis, and gene expression treatment comparison
  • Act as an independent group to generate and distribute unblinded reports for Data Safety Monitoring Board (DSMB) interim data review. Provide statistical analysis on unblinded data
  • Generate integrated summaries of safety and efficacy
  • Write stand-alone statistical reports
  • Validate final reports
  • Perform exploratory data analysis and meta analysis by using advanced statistical methods
  • Support publications with quality tables and graphics

Data Standards Implementation
  • Review and provide input on case report form (CRF) design
  • Write data management plans (DMP)
  • Provide meta data specifications based on the Clinical Data Interchange Standard Consortium (CDISC) standards
  • Map clinical data to conform with Standard Data Tabulation Model(SDTM) structure
  • Validate data structures
  • Define analysis data specifications to conform with Analysis Data Model(ADaM) structure

    Medical Coding and Reporting
    • Provide Adverse Event (AE) or Serious Adverse Event (SAE) coding based on the current MedDRA (FDA recommended) dictionary
    • Provide medication / drug coding based on the current WHO-DRUG dictionary
    • Provide safety update for Annual Report
    • Design and create SAE reporting system for on-going clinical trials or post marketing surveillance.