SIMS offers a secure, integrated environment for planning, conducting and reporting nonclinical safety studies – with live visibility from protocol through data collection to study report and SEND
FOSTER CITY, CA | November 9, 2026
PointCross Life Sciences today launched Xbiom SIMS (Study Information Management System), a preclinical study dchata 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,
– 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: Rahul Madhavan | [email protected] | +1-650-350-1900
Learn more: https://www.pointcross.com