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.