End-to-End Biometrics

Our end-to-end biometrics services encompass comprehensive statistical programming and biostatistics solutions. We specialise in generating detailed tables, listings, and figures, as well as conducting PK/PD analyses. Our expert consultancy and advice ensure precise integrated summaries (ISS/ISE), providing robust support for your clinical and pre-clinical trial data needs. Our services can also be delivered as a Functional Service Provider (FSP).

Our services include:

Biostatistics

  • Writing of the statistical analysis plan (SAP)
  • Mock shell development
  • Consultancy for study design and protocol development
  • Interim analyses for Data Safety Monitoring Boards (DSMBs)
  • Pharmacokinetic non-compartmental analysis (PK)
  • Statistical consultancy
  • Integrated Summary of Safety (ISS) / Integrated summary of efficacy (ISE)
  • Ad hoc, post hoc and exploratory analyses

Programming

  • Creation of SDTM and ADaM datasets
  • Development of tables, listings, and figures (TLFs)
  • All CDISC related deliverables including:
    • Define-XML
    • Annotated/bookmarked CRF
    • Reviewer’s Guides (ADRG, SDRG)
  • Data and edit checks programming

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