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PointCross Single-Track | Cut Study Delivery Time by 75%
SINGLE-TRACK STUDY REPORTING & SEND

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.

75%
Faster delivery than dual-track
$8-12K
Saved per study in operating costs
100%
Data consistency—one source of truth
THE DUAL-TRACK BOTTLENECK

Your current process is costing you weeks and tens of thousands per study

Traditional Dual-Track Process

Weeks 1-6
Study Director manually compiles report from LIMS exports, paper records, histopath PDFs
Week 7
Draft report finalized after multiple QC cycles
Weeks 8-12
SEND contractor re-enters same data, reconciles against final report
Week 13+
Multiple reconciliation rounds for discrepancies
Total: 10-13 weeks to delivery

PointCross Single-Track Process

Week 1
AI compiles all as-collected data, auto-generates draft sections with protocol deviation detection
Week 2
Study Director reviews AI-generated draft, flags signals, adds interpretations
Week 3
Final report approved, SEND datasets generated simultaneously from same locked data
Week 4
Both deliverables validated and submission-ready
Total: 2-4 weeks to delivery
THE BOTTOM LINE

Win bids on price and timeline while improving your margins

Traditional Approach Cost

Study Report (6-7 weeks labor) $6,000
SEND Generation (external) $12,000
Reconciliation & QC cycles $3,000
Total Per Study $21,000

PointCross Single-Track Cost

Automated Study Report $2,500-3,500
SEND Generation (concurrent) ~$3,000
Reconciliation $0
Total Per Study $5,500-6,500

Your Competitive Advantage

$8,000 – $12,000
Saved per study • Reinvest in growth or win more competitive bids
HOW IT WORKS

From as-collected data to submission package in one seamless flow

1

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
2

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
3

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
4

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
ENTERPRISE-GRADE PLATFORM

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.

ZERO-RISK PILOT PROGRAM

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

Contact: [email protected]