Single Track Processing

Single Track Processing, powered by the Xbiom™ platform from PointCross Life Sciences, is an AI-augmented solution designed to unify the generation of Study Reports and SEND datasets into a single, governed workflow. Purpose-built for contract research organizations (CROs) and nonclinical study teams, it eliminates the duplicated effort and manual transcription that characterize traditional dual-track processes—delivering study reports up to two weeks faster and making SEND datasets available at the moment of study report finalization.

Traditional CRO workflows require study directors to manually transcribe data from LIMS, histopathology systems, and bioanalytical platforms into Word templates, while SEND teams separately wrangle the same source data after report completion. This legacy approach can take 8–10 or more weeks, introduces reconciliation risks, and creates costly rework cycles that jeopardize sponsor submission timelines. Single Track Processing addresses each of these pain points through a unified, data-driven pipeline.

Core Workflow Steps

1. Integrate with As-Collected Data Sources: The process begins by connecting directly to LIMS, histopathology, and bioanalytical platforms, ensuring all downstream deliverables are built from the same authoritative source data.
2. Generative AI-Augmented Study Report Generation: Xbiom™ drafts report sections shaped by the Study Director's style and report structure, drawing on actual study data and records, protocol comparisons, and Certificates of Analysis provided by the sponsor client. This allows Study Directors to focus on higher-value interpretation tasks, including pharmacological and biological reasoning and assessment of computed signals.
3. Simultaneous SEND Dataset Readiness: SEND datasets are generated concurrently with the Study Report from the same source data. Version-controlled Study Report and SEND datasets are available for review throughout the process, with final submission-ready SEND packages generated only after study data lock and final Study Report approval.
4. Review and Submit: Study Directors review and approve narrative text and automatically flagged QC findings, including a master list of protocol deviations. SEND datasets are validated using Xbiom's built-in facilities, including eDataValidator, ensuring regulatory compliance before submission.

Key Capabilities

• AI-Generated Narratives with Study Director Review: Report sections are automatically generated following regulatory standards and the organization's own templates, incorporating actual study records and sponsor-provided documents to produce coherent, compliant narratives.
• Simultaneous Study Report and SEND Generation: Both deliverables are produced from the same source data at the same time, ensuring perfect alignment and eliminating the need for manual reconciliation between the two.
• Full Traceability: Every data point traces back to as-collected source data with complete audit trails. Changes propagate automatically through version management, maintaining consistency between the Study Report and SEND dataset throughout the review cycle.
• Smart Quality Checks: Built-in validation checks ensure SEND datasets meet regulatory submission compliance standards before they are finalized and packaged.

Measurable Impact for CROs

• 2+ Weeks Faster Report Delivery: Study reports that previously required weeks of manual effort are completed significantly faster, enabling CROs to win more competitive bids with accelerated timelines.
• Zero Weeks to SEND: SEND datasets are available at the time of study report generation—eliminating the traditional 5–6 week lag between report completion and SEND delivery.
• $10,000 Average Cost Savings per Study: Reduced manual effort and eliminated rework cycles lower per-study costs, improving study margins and overall competitiveness.
• 100% Consistency and Traceability: A shared source of truth from as-collected data ensures perfect alignment between study reports and SEND datasets, with no manual reconciliation delays built into the single-track process.

Single Track Processing is part of the broader Xbiom™ Solutions Platform from PointCross Life Sciences, which also includes capabilities such as eDataValidator, regulatory submission tooling, and nonclinical and clinical data repositories. The solution is designed to support CROs seeking to modernize their nonclinical study reporting operations and deliver submission-ready packages to sponsors with greater speed, accuracy, and compliance confidence.