PointCross Launches Xbiom SIMS, a Digital Transformation Platform for Preclinical Study Operations

SIMS is a secure, integrated environment for planning, conducting, analyzing, and reporting nonclinical safety studies

FOSTER CITY, CA, UNITED STATES, November 9, 2026 /EINPresswire.com/ — PointCross Life Sciences today launched Xbiom SIMS (Study Information Management System), a preclinical study data platform designed for the digital transformation of CRO and sponsor laboratory operations. SIMS brings protocol planning, study conduct, compliance and operational oversight into one connected workflow; drives scheduling and resource planning from digital protocols and digitized SOPs; integrates in-life and bioanalytical data to compute concordance and treatment-relatedness signals as data is collected; and assists Study Directors in drafting study reports, with instant, concurrent generation of submission-quality SEND datasets. As studies run, Study Directors and sponsor monitors share live study visibility, with onboard statistical calculations, configurable visualization templates, and near real-time digital monitoring.

SIMS integrates seamlessly with PointCross’ Single Track™, which identifies treatment-relatedness for each marker on every subject and supports the Study Director’s determinations through over 75 checks for signal concordance, using fold-change against control and baseline across all as-collected data. Because SIMS and Single Track™ run on the same time-stamped study record, the workflow drafts the study report and produces validated, submission-ready SEND datasets the moment the report is ready — traceable to the as-collected data, and up to 6 weeks faster — allowing CRO operations to recapture margin and sponsors to accelerate program timelines.

Automation supports the Study Director’s judgment; it does not replace it. Determinations of biological significance, adversity and NOAEL/NOEL, and the conclusions of the study, remain with the Study Director. SIMS supports GLP and non-GLP studies alike, from nonclinical safety assessment for pharmaceutical and biologic submissions to agrochemical registration and environmental toxicology studies conducted under EPA, OECD and other regulatory frameworks.

“SIMS comes at a time when labs and CROs are looking to evolve beyond legacy LIMS architecture — or are outgrowing spreadsheet-based collection methods. The demands on study data management are increasing: supporting new approach methodologies (NAMs), developing virtual control groups, delivering on innovative study designs, and reporting in a compressed timeframe, while improving operational agility and digital traceability. A modern study data management system must therefore extend far beyond data collection, empowering sponsors with access to their digitized study data,” said Rahul Madhavan, Vice President of Strategic Programs at PointCross Life Sciences.

SIMS supports GLP (21 CFR Part 58, OECD), 21 CFR Part 11 audit trails and e-signatures, and IQ/OQ/PQ validation packages, with go-live in 4 to 6 months.

About PointCross Life Sciences

Since 2007, PointCross has supported CROs and sponsors with platform technology that accelerates and assures the quality of nonclinical analysis and reporting — from SEND dataset preparation, study data validation and study report automation to the digitization and integration of cross-study data repositories with safety signal detection and visualization — all on SOC 2 compliant infrastructure.

Media Contact: Kavan Palangappa | ask@pointcross.com | +1-650-350-1900
Learn more: https://www.pointcross.com

Rahul Madhavan
PointCross Life Sciences
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