Clinical Programming

We provide the following services under Clinical Programming:

Tables/Listings/Graphs (TLGs) Programming & Support:

  • Phase I-IV Clinical Study Reports
  • Interim Analysis
  • Blinded Data Review
  • Drug Safety Monitoring Boards
  • Manuscripts, Publications and Posters
  • Ad Hoc Reports

Submissions:

  • Creation of Integrated Databases
  • TLGs to Support ISS/SCS
  • TLGs to Support ISE/SCE
  • Submission Ready Transport files (CDISC standards as required)
  • Patient Profiles/Listings
  • Product Defense
    - Rapid Responses
    - Regulatory Queries (FDA & EMEA)
    - Ad Hoc and What If Scenarios
  • Assistance with Design of Integrated Databases, Transport Files and Patient Profiles

Other Programming Capabilities:

  • Creation of Derived Datasets for Statistical Analysis
  • Patient Summaries for Narratives
  • Creation of TLG Requirements/Specifications
  • Programming Code and Validation/QC Documentation
  • Adherence to System Development Lifecycle (SDLC) Processes

Regulatory Submission Support Based on Strong Science and Strength of Process. The difference is in the data!

Contact Us Today!