Γ
π Search anything on the website
Β
Powering 25% of FDA SEND Submissions
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
XBIOMβ’ Solutions Platform
End-to-end platform for clinical & nonclinical data automation
Single Track Processing
Deliver Study Reports + SEND submissions in 2β3 weeks
XBIOMβ’ VDR, Study Data I/O, Curation
Securely exchange, organize & curate study data in one place
XBIOMβ’ MDR, Smart Transformer, eDV
Transform and standardize metadata for regulatory-ready submissions
XBIOMβ’Β UDM, Repository
Store all study data in a unified, analysis-ready repository
XBIOMβ’ Regulatory Submission
Package and submit SDTM, ADaM & TFLs for regulatory agencies
XBIOMβ’ Nonclinical Insights
Analyze and compare data across nonclinical studies
XBIOMβ’ Clinical Insights
Run cohort analyses and build statistical analysis plans
eDataValidator
Validate SDTM, ADaM & SEND datasets against CDISC standards
XBIOMβ’Β 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 β 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
CDISC SEND Face to Face at FDA
00
Days
00
Hrs
00
Mins
00
Secs
Apr
01
2019
April 1, 2019
CDISC SEND Face to Face at FDA
April 1-5, 2019
Visit Here
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
XBIOMβ’ Solutions Platform
End-to-end platform for clinical & nonclinical data automation
Single Track Processing
Deliver Study Reports + SEND submissions in 2β3 weeks
XBIOMβ’ VDR, Study Data I/O, Curation
Securely exchange, organize & curate study data in one place
XBIOMβ’ MDR, Smart Transformer, eDV
Transform and standardize metadata for regulatory-ready submissions
XBIOMβ’Β UDM, Repository
Store all study data in a unified, analysis-ready repository
XBIOMβ’ Regulatory Submission
Package and submit SDTM, ADaM & TFLs for regulatory agencies
XBIOMβ’ Nonclinical Insights
Analyze and compare data across nonclinical studies
XBIOMβ’ Clinical Insights
Run cohort analyses and build statistical analysis plans
eDataValidator
Validate SDTM, ADaM & SEND datasets against CDISC standards
XBIOMβ’Β 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 β 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