10-12 Weeks to 2-4 Weeks. $20K+ Cost to $6K Per Study.
Generate submission-ready Study Reports and SEND datasets simultaneously from your LIMS, histopath, and bioanalytical data—no manual transcription, no reconciliation delays, no quality gaps.
Your current process is costing you weeks and tens of thousands per study
Traditional Dual-Track Process
PointCross Single-Track Process
Win bids on price and timeline while improving your margins
Traditional Approach Cost
PointCross Single-Track Cost
Your Competitive Advantage
From as-collected data to submission package in one seamless flow
Direct Source Integration
Connect to your existing systems without disruption:
- LIMS (Provantis, Pristima, Ascentos)
- Handwritten necropsy notes (OCR)
- Histopathology PDFs and annotations
- Bioanalytical data from any source
- Protocol versions and amendments
AI-Powered Compilation
Intelligent processing and validation:
- Auto-detect protocol deviations
- Generate computed signals across domains
- Create templated displays with drill-down
- Flag noteworthy findings
- Ensure data completeness and quality
Study Director Review
Maintain complete control and oversight:
- Review AI-generated draft sections
- Flag signals for inclusion
- Add interpretations and annotations
- Approve or edit each section
- Full CFR Part 11 compliance and audit trail
Concurrent SEND Generation
One lock, dual outputs—perfect alignment:
- SEND.xpts from same source data
- Define.xml auto-generated
- nSDRG with flagged signals
- Comprehensive conformance validation
- Zero reconciliation required
Built on proven technology trusted by research organizations
Universal Data Model
Repository for all collected data accessible for any purpose—bio-stats, report generation, and regulatory submission.
Version Control & Amendments
Automated tracking for multiple protocol amendments with full change history and conformance checking against each version.
Automated Reconcilers
Check “As Expected” (from protocol/amendments) against actual study conduct, flagging deviations for Study Director review.
Metadata Repository
Templates, standards, terminologies, and mappings for transformation to SEND SDTM—customized to your organization.
Signal Detection & Analysis
Computed signals across clinical pathology, observations, necropsy, histopath, bioanalytical, and multi-omics data.
Quality & Compliance
CFR Part 11 compliant with full audit trails, electronic signatures, version management, and QA/audit support documentation.
See it work with your actual data before any commitment
What You Provide
- Completed non-GLP study (can be retrospective)
- Study report template
- Protocol with amendments
- LIMS extracts from your system
- Handwritten/scanned records
What We Deliver
- AI-generated Study Report (your template)
- Complete SEND datasets with Define.xml
- Side-by-side comparison vs. your process
- Timeline and cost analysis
- Integration assessment for your systems
Timeline: 2-4 weeks • Investment: $0 for qualified CROs
