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- Xbiom - Version REGULATORY - Workbench ...
Xbiom - Version REGULATORY -Workbench for Nonclinical Regulatory Study Planning, Preparation and Submission Packaging
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
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- 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
- 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.