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PointCross Life Sciences
PointCross | AI-Powered Study Reports & SEND Generation
2+ Weeks
Faster Report Delivery
From Data Lock to Sponsor Delivery
100%
Report-SEND Alignment
One Dataset, Two Deliverables: Study Report & SEND
$10k
Cost Reduction per Study
Lower costs. Higher margins. Better outcomes.
0
Weeks to SEND
Instant SEND Dataset on Data Lock
THE CHALLENGE

Study Report & SEND timelines take 8+ weeks at traditional CROs

Weeks of Manual Work

Study directors spend hours manually transcribing data from LIMS, histopathology systems, and bioanalytical platforms into Word templates—a time-intensive, error-prone process.

Duplicated Effort, Compounded Delays

SEND teams wait for Study Report completion, then separately wrangle the same source data to create SEND datasets. This duplicated effort adds 5-6 weeks of unnecessary lag time and introduces reconciliation risks.

Quality & Compliance Risk

Manual transcription and dual data entry create discrepancies. Late-stage corrections cascade through both deliverables, triggering costly rework cycles and jeopardizing submission timelines for Sponsors.

CURRENT DUAL TRACK PROCESS
Current Dual Track Process

LEGACY PROCESS TAKES 8-10+ WEEKS FOR STUDY REPORT AND SEND GENERATION

THE SOLUTION

Study Reports Delivered 2 Weeks Faster; SEND Dataset Available at Time of Study Report Generation

1
Integrate with As-Collected Data Sources LIMS • Histopath • Bioanalytical
2
Generative AI Augmented Study Report Generation shaped in the Study Director's style and report structure; allows Study Director to focus on interpretation of study data, including Pharmacological & Biologic Reasoning, Assessment of Computed Signals
3
SEND is Ready at the Time of Study Report Generation version controlled Study Report and SEND datasets allows review while final, submission ready SEND packages are generated only after Study Data Lock following final approval of Study Report
4
Review & Submit Study Directors review and approve narrative text, automatically flagged QC findings including master list of deviations from protocol; SEND datasets pass validation and QC checks using Xbiom's facilities including eDataValidator
  • ✓
    AI-Generated Narratives with Study Director Review

    Xbiom™ generates Report Sections based on Study Director and Study Templates, Actual data and records from Study Conduct, and where needed in comparison with Protocol and CoA provided by Sponsor Client. Create coherent, compliant study narratives automatically, following regulatory standards and your organization's templates.

  • ✓
    SEND Generation at the Time of Study Report Finalization

    Study reports and SEND datasets generated simultaneously from the same source data, ensuring perfect alignment and minimizing time for reconciliation.

  • ✓
    Full Traceability

    Every data point traces back to as-collected source data with complete audit trails. Changes propagate automatically with version management to maintain consistency between Study Report and SEND.

  • ✓
    Smart Quality Checks

    Built-in validation checks for regulatory-submission compliant SEND datasets

SINGLE TRACK PROCESS
Single Track Process
THE IMPACT

Transform your CRO's efficiency and competitiveness

2 weeks

Faster Study Report Delivery

Complete study reports that previously took weeks now ready 2 weeks faster. Win more competitive bids with accelerated timelines.

$10K

Cost Savings on Average for Each SEND Dataset

Re-capture cost savings to improve study margins.

100%

Consistency & Traceability between Study Report and SEND Dataset - Built In to the Single-Track Process

Shared source-of-truth from as-collected data ensures perfect alignment between study reports and SEND datasets. No manual reconciliation delays.

Zero

Weeks to SEND

5-6 weeks faster study deliverable package.