The Dual-Track Constraint
In standard nonclinical CRO operations, Study Report generation and SEND dataset preparation are performed as separate, sequential processes. The Study Report track integrates data from LIMS and ancillary sources, applies biostatistical analysis, determines clustering and exclusions, identifies noteworthy findings, and produces the final report. This process typically requires 4-6 weeks after study completion.
SEND generation can begin only after the Study Report is finalized because SEND datasets require metadata that emerges from the report, including clustering decisions (NOMDY), subject exclusions, and correlations between observation domains. The SEND track extracts this metadata, re-processes the underlying data into CDISC SEND IG format, validates conformance, and generates Define.XML and nSDRG documentation. This adds an additional 4-6 weeks.
The result is duplicated data processing, manual reconciliation between outputs, and 20-40 hours of Study Director time per study consumed by coordination rather than scientific interpretation.
Single Track Architecture
Single Track resolves the sequential dependency by processing Study Report and SEND requirements through a unified workflow.
Continuous Data Ingestion Xbiom™ integrates directly with CRO LIMS systems and ingests data continuously throughout study conduct. Data is harmonized and standardized into the Unified Data Model (UDM) in real time. By study completion, the data foundation is already structured and prepared for downstream processing.
Auto-Computed Biostatistics and Signal Detection Following study completion, Xbiom™ automatically computes biostatistics and safety signals based on protocol specifications. Statistical test selection follows standard methodology (Shapiro for normality, Levene’s for homogeneity, appropriate parametric or non-parametric tests based on data characteristics). Signals are classified by direction and magnitude (I, I+, I++, D, D+, D++) and flagged for Study Director review.
SEND Metadata Population SEND metadata populates in the Metadata Repository (MDR) in parallel with biostatistics computation rather than sequentially after Study Report completion. Trial Summary parameters, Trial Design domains (TA, TE, TX, DM, EX), and controlled terminology mappings are captured as part of the unified workflow.
AI-Assisted Draft Report Generation Xbiom™ uses generative AI to produce draft Study Report sections from structured data and computed findings. The AI translates tabulated results into narrative prose following standard nonclinical report conventions. Study Directors review, edit, and approve all generated content. Scientific interpretation remains with the Study Director; AI handles mechanical drafting.
Unified Data Lock and Dual Output Generation Following Study Director review and approval, a single data lock governs both outputs. The finalized Study Report and SEND dataset generate from the same UDM source with identical analytical decisions applied. Consistency between outputs is architectural rather than reconciliation-dependent.
Applicability
Single Track applies to all nonclinical studies requiring a Study Report. For the approximately 30% of studies requiring SEND datasets (primarily GLP studies destined for FDA or PMDA submission), Single Track eliminates the dual-track architecture and delivers both outputs simultaneously. For studies requiring only the Study Report, Single Track provides automated draft generation and accelerated delivery.
Platform Components
Single Track leverages existing Xbiom™ platform components:
- UDM (Unified Data Model): Normalized, harmonized data repository serving as the single source for all outputs
- MDR (Metadata Repository): Governance of controlled terminology, SEND metadata, and transformation mappings
- Smart Transformer: Automated conversion of source data to SEND-compliant format with appropriate controlled terminology
- eDataValidator: Conformance validation against FDA and PMDA business rules prior to submission
- IGO (Integrated Graphics Object): Signal visualization and TFL generation for Study Director review
Technical Specifications
- LIMS Integration: Adaptors available for Pristima, Provantis, and other common nonclinical LIMS platforms
- Standards Support: CDISC SEND IG 3.0, 3.1; current CDISC Controlled Terminology versions; Define.XML 2.0
- Compliance: SOC 2 Type II, ISO 9001:2015, ISO 27001:2022, 21 CFR Part 11
- Deployment: SaaS (AWS hosting); alternative hosting environments available
- Validation: PointCross provides validation evidence documentation for GLP qualification
Operational Metrics- Table Format
| Metric | Dual-Track | Single Track |
| Timeline (Study Report + SEND) | 8-10 weeks | 1-2 weeks |
| Per-Study Processing Cost | $18K-$27K | $9K-$14K |
| Study Director Coordination Time | 20-40 hours | 4-8 hours |
| Report-SEND Reconciliation | Manual | Architectural |
Implementation
Initial deployment focuses on non-GLP studies to minimize disruption to qualified workflows. PointCross provides configuration, onboarding, and training as part of the implementation engagement. On-demand virtual support (Data Concierge) is available for complex study designs, specialized biostatistical analysis, and report generation assistance.
For GLP studies, PointCross supports validation and qualification activities with complete documentation. Transition to GLP proceeds following successful non-GLP deployment and SOP alignment.
Minimum commitment: 50 studies per year.
Experience
PointCross prepares 25% of SEND submissions to FDA. Zero technical rejections across 10,000+ studies. 850+ sponsors and CROs served globally. 25 years of regulatory data operations.