Biostatistical Services and Programming

inSeption collaborates with other organizations who share in our commitment to quality and exhibit an ability and proven expertise in providing high quality deliverables on time and within budget.

Overview of expertise:

  • Adaptive and traditional trial design
  • Protocol development
  • Statistical Analysis Plan development
  • EDC implementation (eg, Medidata RAVE, Oracle OC/RDC and Oracle InForm, OpenClinica)
  • Data management, including data standardization (CDASH) for clinical study submissions
  • Biostatistics, including interim analysis, Data Monitoring Committee (DMC) support, topline reviews, and CSR support
  • SAS Programming (eg, SDTM/ADaM datasets, TLFs, and ISS/ISE support)
  • Validated and compliant e-submission data package preparation (eg, SDTM annotated CRF, define.pdf, or define.xml)
  • Pharmacovigilance support