WHY SHOULD SPONSORS CONSIDER XBIOM?

  • Nonclinical studies are being outsourced to CROs and Bio-Analytics Service companies but Sponsors:
    • Own and execute their drug programs

    • Define the studies that must be conducted

    • Decide the SEND IG and CT versions to be used and meeting FDA Business and CDISC Conformance Rules

    • Are responsible for regulatory submissions and defending regulatory questions and challenges

    • Need to avoid meeting FDA Technical Rejection Criteria

  • Control the process from planning to submission on a validated software as a service system without breaking capital budgets and incurring data management costs

  • Access Data Services at every stage by SEND specialists who keep abreast with the ongoing changes in standards, IG, CTs and Validation Rules


Xbiom™REGULATORY WORKBENCH FOR NONCLINICAL SUBMISSIONS AND STUDIES

AVAILABLE IMMEDIATELY . SOFTWARE AS A SERVICE . AWS CLOUD

Workflows for planning submissions and studies Seamless encrypted interactions with CROs Define Study and Trial Design Models Merge SEND study components and validate SEND studies provided by CROs QC Dashboards, Quality Tools and Validators