DIGITAL METADATA GOVERNANCE & CLINICAL REGULATORY COMPLIANCE

  • Management and governance of CDISC and corporate standards driven metadata, data models and study level models from protocol to submission with workflows and controls.
  • Solution for clinical trial data submissions in CDISC SDTM to comply with FDA and PMDA mandates.
  • 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