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

To get started follow these simple steps


  • Request an online demo or a demo video from regulatory@pointcross.com
  • If there is interest, enter into an NDA or confidentiality agreement.
    Download here for our standard Mutual NDA or send your standard NDA to regulatory@pointcross.com

  • Once NDA is place your site will be activated and online training will be provided
  • Contact regulatory@pointcross.com for any optional services for study models, trial design, SEND merging or standardization services, quality checking of SEND against Study Reports


Download our presentation on SEND Managed Services and SaaS Regulatory Nonclinical

Click here for information on our on-premise version of DSIMS


Pricing


  • No monthly subscription
  • One time fee for set-up and online training – Fee Waived for all sites set up in 2019
  • A single one-time charge of $4,000 for each unique StudyID managed in Xbiom Regulatory
    No limits on time, users or # of studies Minimum of 4 studies per year or $16,000 per year
  • Fixed priced Study Modeling, Data Standardization or quality checking services – quoted on request


Email us at regulatory@pointcross.com to set up an online demo or a on-site meeting or call us at +1 844-382-7257 in US.

  • Downloada free white paper on the Xbiom Workbench for Regulatory Nonclinical Submissions and Studies

    Email : regulatory@pointcross.com

    Phone : +1 844-382-7257in US.



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