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"In a clear presentation it gave a perfect insight into our struggle with SDTM and legacy data"

Organon

Aims and ScopeĀ 

Articles published in the journal will cover topics related to statistical programming, program and application development as well as current technologies, software and tools used for programming. Regulatory requirements and standardization are discussed in addition to the managerial aspects of programming in the pharmaceutical and life sciences industry.

Topics include but are not limited to:

  • Statistical programming
  • Representation of clinical data
  • Fundamental programming techniques and macros
  • Publishing of results
  • Electronic submission of clinical data
  • Statistical Routines
  • Laboratory data
  • Pharmacokinetic and Pharmacodynamic programming
  • Program and Application development
  • Software development lifecycle
  • Validation and quality management
  • Development, implementation and use of clinical data management, remote data capture and Pharmacovigilance systems
  • Regulatory environment and regulations
  • Development of standards
  • CDISC Implementation
  • Use and implementation of medical dictionaries
  • Project and resource planning
  • Working with consultants/ CROs
  • Off-shoring and working in global teams
  • Metrics
  • Training and education programs
  • Infrastructure and IT support