About
About Us
Our story, leadership, mission
Careers at PointCross
Join our global team
Conferences and Events
Where to find us
Partners
Strategic collaborations
Solutions
SEND Services
SEND Dataset Preparation
SEND-ASSURE QC of SEND Datasets
SEND Quote Generation
Interim Study Monitoring
Interim Monitoring of Nonclinical Studies
Interim Monitoring of Clinical Trials
Digital Study Report (DSR) Generation
Auto-generate compliant study reports from your data
Automated SDTM Generation from EDC
Convert EDC data to SDTM-ready datasets automatically
Biosample Tracking for Specialty Assays
Track and manage biosamples across specialty & translational assays
Clinical or Nonclinical Repository
Centralized repository to store, search & visualize study data
Products
XBIOM™ Solutions Platform
End-to-end platform for clinical & nonclinical data automation
Single Track Processing
Deliver Study Reports + SEND submissions in 2–3 weeks
XBIOM™ VDR, Study Data I/O, Curation
Securely exchange, organize & curate study data in one place
XBIOM™ MDR, Smart Transformer, eDV
Transform and standardize metadata for regulatory-ready submissions
XBIOM™ UDM, Repository
Store all study data in a unified, analysis-ready repository
XBIOM™ Regulatory Submission
Package and submit SDTM, ADaM & TFLs for regulatory agencies
XBIOM™ Nonclinical Insights
Analyze and compare data across nonclinical studies
XBIOM™ Clinical Insights
Run cohort analyses and build statistical analysis plans
eDataValidator
Validate SDTM, ADaM & SEND datasets against CDISC standards
XBIOM™ IGO - Immersive Graphics Object for TFL generation
Generate publication-quality Tables, Figures & Listings (TFLs)
Services
Data Standardization
SEND for Nonclinical
SDTM for Clinical
ADaM for Clinical
Biomarker Assays
Data Quality Assurance
SEND ASSURE
SEND ASSURE and Corrections
Data Concierge – Data as a Service
Nonclinical
Clinical & Translational
LEGACY STUDIES
Digitization, Analysis and Warehousing of Legacy Clinical Trial Data
Resources
PointCross Blog
Latest insights & blogs
Clinical Resources
Whitepapers & technical guides
Nonclinical Resources
SEND, GLP study materials
All Resources
Webinars, Whitepapers and others
Case Studies
Customer success stories
SRR Files & Template
Ready-to-use submission-ready report templates
Contact us
Contact Us
Request a Demo
About
About Us
Careers at PointCross
Conferences and Events
Partners
Solutions
SEND Services
SEND Dataset Preparation
SEND-ASSURE QC of SEND Datasets
SEND Quote Generation
Interim Study Monitoring
Interim Monitoring of Nonclinical Studies
Interim Monitoring of Clinical Trials
Digital Study Report (DSR) Generation
Automated SDTM Generation from EDC
Biosample Tracking for Specialty Assays
Clinical or Nonclinical Repository
Products
XBIOM™ Solutions Platform
XBIOM™ VDR, Study Data I/O, Curation
XBIOM™ MDR, Smart Transformer, eDV
XBIOM™ UDM, Repository
XBIOM™ Regulatory Submission
XBIOM™ Nonclinical Insights
XBIOM™ Clinical Insights
eDataValidator
Single Track Processing
Services
Data Standardization
SEND for Nonclinical
SDTM for Clinical
ADaM for Clinical
Biomarker Assays
Data Quality Assurance
SEND ASSURE
SEND ASSURE and Corrections
Data Concierge – Data as a Service
Nonclinical
Clinical & Translational
LEGACY STUDIES
Digitization, Analysis and Warehousing of Legacy Clinical Trial Data
Resources
PointCross Blog
Clinical Resources
Nonclinical Resources
All Resources
Case Studies
SRR Files & Template
Contact us
Contact Us
Request a Demo
Face-to-Face
CDISC
SEND
at
FDA
Home
By using this website, you agree to our
cookie policy
Close
