Clinical Regulatory Compliance

  • Solution for clinical trial data submissions in CDISC SDTM to comply with FDA and PMDA mandates.
  • Workflows and technology for specifying data standards with CROs that deliver clinical study data in SDTM.
  • Accept and validate data from CROs with centralized data management and provisioning to biostatisticians and programmers for data analysis.
  • Plan interim and final submissions, package M5 folders with ISS, ISE and TFLs for submitted studies.

Xbiom™Regulatory - Clinical