PointCross launches Xbiom SIMS for preclinical study operations

PointCross Life Sciences has launched Xbiom SIMS, a digital platform for planning, running and reporting nonclinical safety studies across CRO and sponsor labs. The system is designed to speed study reporting, improve traceability and support regulatory workflows for GLP and non-GLP programs.

Why it matters: - PointCross is targeting preclinical study operations that still rely on legacy LIMS tools or spreadsheets. - Xbiom SIMS is designed to connect study planning, execution, analytics and reporting in one workflow. - The platform aims to shorten study timelines and improve digital traceability for CROs and sponsors. - PointCross says the workflow can help recapture CRO margin and accelerate sponsor program timelines.

What happened: - PointCross Life Sciences launched Xbiom SIMS, a Study Information Management System for preclinical study data management. - The launch centers on nonclinical safety studies for CRO and sponsor laboratory operations. - The platform brings protocol planning, study conduct, compliance oversight and operational tracking into one connected environment. - The system also supports live visibility for Study Directors and sponsor monitors as studies run.

The details: - SIMS uses digital protocols and digitized SOPs to drive scheduling and resource planning. - The platform integrates in-life and bioanalytical data to compute concordance and treatment-relatedness signals as data is collected. - SIMS assists Study Directors in drafting study reports and generates submission-quality SEND datasets at the same time. - The workflow includes onboard statistical calculations, configurable visualization templates and near real-time digital monitoring. - SIMS integrates with PointCross Single Track™, which identifies treatment-relatedness for each marker on every subject. - Single Track™ supports Study Director determinations with more than 75 checks for signal concordance using fold-change against control and baseline across as-collected data. - SIMS and Single Track™ operate on the same time-stamped study record. - PointCross says the combined workflow can produce validated, submission-ready SEND datasets up to 6 weeks faster. - Automation supports the Study Director’s judgment and does not replace it. - Decisions on biological significance, adversity, NOAEL/NOEL and final study conclusions remain with the Study Director. - SIMS supports GLP and non-GLP studies. - The platform is built for pharmaceutical and biologic submissions, agrochemical registration and environmental toxicology studies under EPA, OECD and other regulatory frameworks. - SIMS supports GLP compliance under 21 CFR Part 58 and OECD standards. - The platform also supports 21 CFR Part 11 audit trails and e-signatures. - Validation support includes IQ/OQ/PQ packages. - PointCross says go-live can take 4 to 6 months. - The company has supported CROs and sponsors since 2007 with tools for SEND dataset preparation, study data validation, study report automation, cross-study repository digitization, safety signal detection and visualization. - PointCross says its infrastructure is SOC 2 compliant. - The company lists media contact information at ask@pointcross.com and +1-650-350-1900. - More information is available at the company’s announcement. - PointCross also shared a LinkedIn page at the company’s LinkedIn page.

Between the lines: - The launch reflects a broader push to replace manual and fragmented study management with integrated digital workflows. - PointCross is pitching SIMS as both an operational tool and a compliance system, which matters because preclinical work must balance speed with regulated documentation. - The emphasis on NAMs, virtual control groups and compressed reporting timelines suggests the platform is aimed at newer study designs as well as traditional workflows.

What’s next: - CROs and sponsors adopting SIMS will need to validate the platform and move through implementation before go-live. - PointCross is positioning the product for use across safety assessment, registration and toxicology programs under multiple regulatory regimes. - The company is betting that faster report generation and cleaner traceability will be enough to pull users off legacy systems.

The bottom line: - PointCross is turning preclinical study management into a digital, connected workflow built to speed reporting without shifting scientific judgment away from Study Directors.