Service Chain

SDTM

  • SDTM CRF Annotation
  • Specification & coding
  • SDTM data generation
  • Pinnacle21 checking
  • SDRG preparation
  • Define.xml generation
  • Issue Tracking

ADaM and TLFs

  • TLF mock-up development
  • Specification & coding
  • ADaM data generation & validation
  • Pinnacle21 checking
  • ADRG preparation
  • Define.xml generation
  • TLF generation and validation

Biostatistics

  • Study Design
  • Protocol Development
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)
  • NDA Submission
  • Regulatory Interactions
  • Manuscript / Abstract Development
  • DMC Management and DMC Charter

ISS / ISE Services

picture
  • ISS / ISE strategies
  • ISS / ISE SAP
  • Gap analysis & consistency
  • Mock-up development
  • Integrated ADaM

30+ Projects

ISS/ISE Experience

  • TLF
  • Validation: pooled vs Individuals
  • Data submission readiness
  • Unique method to handle repeat deliverable

Validation Keys

Q2 has independent SDTM/ADaM/TFL validation systems, checking and reviewing including e.g.: mapping, integrity, logic, compliances, opencdisc, metadata and PPV, to ensure our effective deliverables with excellent quality.

validation

Copyright ©2018-now Q2 Business Intelligence

logo