Xbiom™ Platform Introduces AI-Enabled Automated Workflow that Eliminates Redundant Processes, Reduces Costs by 50%, and Accelerates IND-Enabling Regulatory Submission Readiness by 2-4 Weeks
FOSTER CITY, Calif., Dec. 18, 2025 /PRNewswire-PRWeb/ -- PointCross today announced general availability of an AI-augmented transformative single-track process for nonclinical data management. The innovation enables simultaneous generation of submission-ready Study Reports and digitized SEND datasets, eliminating redundant workflows that currently cost the industry an estimated $150 million annually while reducing turnaround time and increasing margins for Contract Research Organizations (CROs) and Sponsor Laboratories.
The Xbiom™ Nonclinical Study Data Management platform seamlessly compiles Study Reports for Study Directors while automatically generating SEND (Standard for Exchange of Nonclinical Data) formatted submittable data packages—all from a single governed data stream.
Addressing Critical Industry Inefficiency
The in vivo nonclinical industry currently operates two separate labor-intensive processes using the same source data: Study Report generation and SEND dataset creation. Each track consumes approximately $75 million annually. This duplicative approach, dating to pre-2014 FDA SEND mandate decisions, contrasts sharply with clinical trial data management where regulatory standards integrate efficiently into unified workflows.
"Traceability of the SEND dataset to the Study Report, and from the Study Report to the data collection system, remains the most important quality attribute for analysis rigor and submission quality," said Rahul Madhavan, VP, Strategic Programs. "That traceability is robustly maintained with single-track processing, lowering costs while reducing data fragmentation."
The Single-Track Solution
Xbiom's single-track workflow delivers unprecedented efficiency without altering existing nonclinical workflows:
- Automatically generates validated SEND datasets, Define.xml, and nSDRG upon study lock with full regulatory compliance (FDA TCG 8.1.2, 8.1.3, 4.1.3)
- Seamlessly ingests LIMS and non-LIMS data while computing statistics and auto-generating Study Report tables, figures, and narratives
- Eliminates reconciliation and separate QC checks between Study Reports and SEND datasets
- Integrates with all major LIMS platforms without workflow disruption
"This mirrors how clinical trial data management works with SDTM and Clinical Study Reports," Madhavan explained. "SEND becomes a natural by-product of data analysis and Study Report generation."
Transformative Value Proposition
For typical repeat-dose toxicology studies where CROs invest $10,000+ in Study Report generation and another $10,000+ for SEND production, organizations can:
- Reduce overall study costs by 30-50%
- Improve operating margins by 10+ percentage points
- Accelerate submission readiness by 2-4 weeks
- Ensure 100% consistency between Study Reports and SEND datasets
With approximately 6,000 nonclinical studies submitted to FDA annually, this SaaS solution addresses substantial market opportunity in an increasingly competitive environment.
The platform is currently operational with validated regulatory compliance (IQ, OQ, PQ) and includes comprehensive capabilities: templated TFLs, biostatistics, automated PK calculations, smart transformers for specialty assays, eCTD table generation, and real-time monitoring with validation checks.
About PointCross
PointCross is a leader in nonclinical data management and regulatory compliance solutions, trusted by over 300 Sponsor and CRO customers annually. The Xbiom™ platform provides comprehensive automation for in vivo preclinical studies, combining deep expertise in toxicology, pharmacokinetics, and regulatory science with advanced data management capabilities.
Media Contact:
Andrew Parry
PointCross Life Sciences
1 (650) 350-1900
https://pointcrosslifesciences.com/
Media Contact
Andrew parry, PointCross Life Sciences, 1 650-350-1900, [email protected], https://pointcrosslifesciences.com/
SOURCE PointCross Life Sciences
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