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  • ENGLISH
  • FRANCAIS
  • Services
    • Services Overview
    • Clinical Trial Operations
      • Protocol Development and Study Design
      • Feasibility and Study Start Up
      • Patient Recruitment
      • Project Management
      • Clinical Operations
      • Centralized Monitoring
      • Decentralized Clinical Trials (DCT)
      • Centralized eTMF
      • Medical Services
    • Regulatory and Drug Development Consulting
      • Clinical Strategy
      • Nonclinical
      • Chemistry, Manufacturing, and Controls (CMC)
      • Regulatory Affairs
      • GxP Strategy Consulting
      • Publishing and Submissions
      • Medical Writing
    • Government and Public Health Services
    • Biometrics
      • Biostatistics and Statistical Programming
      • Data Management
    • Clinical Pharmacology Modeling Simulation
      • Clinical Pharmacology Integrated Drug Development
      • Model Informed Dose & Drug Development (MIDD)
      • Pharmacometrics (PMx), Pharmacokinetics, Pharmacodynamics (PK/PD)
      • DMPK and Translational Discovery and Development
  • Therapeutic Expertise
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Statistical Programming

  • Biostatistics and Statistical Programming
  • Biostatistics
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  • Biostatistical Consulting

Our team has CDISC expertise and can set up a CDISC strategy that fits corporate, financial, and regulatory goals. We have created CDISC, SDTM, and ADaM–compliant datasets for over 60 studies and have performed many CDISC-compliant regulatory submissions. Our experience includes:

  • Ongoing studies, historical databases, and legacy conversions
  • Programming specifications for SDTM and ADaM
  • SDTM and ADaM domains (SAS datasets/transport files)
  • SDTM annotated CRF (acrf.pdf)
  • Define.xml files for SDTM and ADaM
  • Reviewer’s guides in multiple formats (e.g., PHUSE standard) including validation confirmation and Pinnacle 21 notes
  • Study program guides that provide details on how programs and macros are used to create the SDTM and ADaM domains

Contact Us

Let us partner with your team on bringing new therapies to light. Get in touch to get started.

CONTACT US

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