Reduce Time to NDA Approval
Increase the probability of regulatory success with evidence-driven engagement. Automate SEND dataset generation, validate with eDV, and ensure 100% data verification.
- 21 CFR Part 11 Compliant
- Reduce Programming by 75%
- Used by FDA CDER
Comprehensive Data Solutions
Whether you need a fully managed Data Concierge service or an enterprise platform for self-service analytics, PointCross delivers.
Data Concierge
A white-glove virtual team service. We handle data curation, standardization, and analysis for your nonclinical and clinical studies—saving you 70% vs internal staffing.
Explore Services →Regulatory & Standards
Ensure 100% compliance with FDA/PMDA requirements. From SEND dataset preparation to automated SDTM generation and eDataValidator.
View Capabilities →XBIOM™ Platform
The unified R&D data platform. Ingest, standardize, analyze, and visualize data across the entire drug development lifecycle in one secure environment.
Discover XBIOM →Legacy Modernization
Unlock the value of past studies. We digitize static PDFs and legacy formats into searchable, analysis-ready datasets in just 3-5 weeks.
Modernize Data →Clinical Operations
Streamline clinical trials with real-time interim monitoring, biosample tracking, and automated data flows from EDC to SDTM.
Optimize Ops →Biomarker Data
Integrate complex omics and biomarker data with clinical and nonclinical datasets for true translational insight and precision medicine.
Explore Biomarkers →SEND Services & eDataValidator
Ensure 100% submission readiness with our industry-leading validation tools and expert services.
Rapid SEND Automation
Reduce data programming time from 6-8 weeks to 1-2 weeks. Our automated platform handles dataset generation with precision.
100% Data Verification (eDV)
Eliminate validation issues with eDataValidator. Verify study reports against datasets accurately before submission.
Why Regulatory Success is at Risk
Time-Consuming Submission Prep
Traditional programming delays essential regulatory engagement.
Data Inconsistencies
Manual validation misses discrepancies leading to pushback.
Delayed Signal Detection
Waiting for lockouts prevents early detection of toxicological trends.
Solutions by Job Role
We understand the unique challenges of your role. See how PointCross empowers your specific function in the drug development lifecycle.
Biometrics & Data Management
Automate SDTM generation, validate datasets instantly, and reduce data wrangling costs with our Data Concierge service.
Toxicologists & Safety Scientists
Visualize safety signals across studies, access interim data in real-time, and generate digital study reports without IT delays.
Regulatory Affairs
Ensure 100% submission readiness. Verify SEND/SDTM compliance before submission and get expert correction support.
Clinical Operations
Gain control over trial data flow. Track biosamples, monitor interim trial progress, and integrate biomarker data seamlessly.
Enterprise-Grade Security & Compliance
Built for regulated environments. Trusted by FDA CDER and leading Pharma sponsors.
21 CFR Part 11
Fully compliant records management system with complete audit trails.
GDPR & EU Data Protection
Compliant with applicable data protection laws for personal data processing.
ISO 9001:2015
Quality Management System incorporates processes complying with ISO standards.
Enterprise Security
SSO (AD, LDAP, SAML), encryption, and fine-grained access controls.
Ready to accelerate your R&D data operations?
Whether you need to submit an NDA next month or modernize your entire legacy archive, PointCross has the platform and people to make it happen.
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PointCross Life Sciences Inc. delivers proven life sciences software solutions to support drug development through a suite of Nonclinical and Clinical offerings.
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