Semantically harmonize and combine all your data from clinical trials, molecular biomarkers, bio-sample availability and bioinformatics into Xbioms’™ searchable warehouse with a universal data model to find cohorts, signals or do analytics across domains.
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.
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.
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.
Download the specification for Study Report Reference (SRR) files
NonClinical Study Report AS-TABulated in machine readable format for 100% consistency checking against SEND datasets.
Webinar: A cost effective way of automating 100% checking of your SEND datasets.
FDA's CDER now accepts Animal Rule (AR) for Vaccines and anti-virals in SENDIG-AR v1.0 standard as of March 15th, 2020.
Click here to find out more if you have time critical submissions which include these type of studies