TheXbiom™ SUITE AND SERVICES

    Clinical Solutions

    Clinical Trial & Molecular Biomarker Research


    Semantically harmonize and integrate all your data from clinical trials, molecular and immuno biomarkers, bio-sample availability and bioinformatics into Xbioms’™ searchable warehouse with a universal data model to find cohorts, signals or do analytics across domains.

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    Clinical Metadata Governance & Regulatory Compliance


    Manage CDISC standards driven metadata and data models for all stages of clinical trials from protocols to eCRF to submission with validated workflows. Xbiom lets sponsors specify data models and receive studies from CROs in SDTM, to validate and package technically conformant clinical data for regulatory submissions to the FDA and PMDA.

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    Nonclinical Solutions

     

    Nonclinical Cross-Study Analytics & Warehousing


    Semantically harmonize and combine all your Nonclinical study data into Xbioms’™ searchable warehouse with a universal data model to find subjects, dose groups or studies that show safety signals or patterns of interest for analysis and cross domain views.

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    Xbiom Nonclinical Regulatory Submissions & Study Lifecycle


    Workbench for all practicing regulatory and data management teams at sponsors. Xbiom Nonclinical Regulatory Submissions and Study Lifecycle Solutions is offered as a Software as a Service on the AWS cloud, and is validated and qualified for regulatory use.

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    Driving

    Success For Our Valued Customers

    We thank our customers for their trust shown in us
    and take pride in our accomplishments.


    Our

    VISION

    To standardize and contextually integrate all data collected in discovery or nonclinical and clinical trials, with genomic and immune response data from the patient from their bio-samples or other, to support precision medicine development and translational research to discover treatments for illness and disease.

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    Effective March 15, 2021: Support for SEND DART IG 1.1 per FDA Data Standards Catalog
    ( FDA Announcement; FDA Data Standards Catalog)
    Our Software solution (Xbiom) and services are set up to accommodate DART IG 1.1, and we have been generating SEND datasets for DART studies including EFD, Fertility and Early Embryonic Development and Pre-Natal and Post Natal Development studies. We also have worked with multigeneration reprotoxic studies in the past. To learn more about our SEND conversion services, contact us at dsservices@pointcross.com.


    FDA to enforce the Technical Rejection Criteria (TRC) beginning Sept 15th, 2021 ( Technical Rejection Criteria for Study Data)

    The TRC has been added to the existing eCTD validation criteria to enforce compliance with the SEND requirements for study types modelled in an FDA supported SEND Implementation Guide (SENDIG) version. Beginning September 15, 2021, any electronic submission that does NOT pass the aforementioned validation criteria will be rejected. Our PointCross Validation engine has already been extended to ensure that all datasets are checked against the Technical Rejection Criteria. You can verify your datasets and make sure that they do pass the TRC by using our eDataValidator.