SIMS Enhances Preclinical Study Data Management

FOSTER CITY, CA, UNITED STATES, November 9, 2026 /CourierPR/ -- PointCross Life Sciences today unveiled Xbiom SIMS (Study Information Management System), a digital platform designed to streamline and transform the operations of contract research organizations (CROs) and pharmaceutical and biotech sponsors in the realm of preclinical study data management. The new system, which brings together planning, execution, analysis, and reporting into a single, integrated workflow, is a significant step in the ongoing digital transformation of the preclinical study landscape.

SIMS is a secure, integrated environment that supports the planning and execution of nonclinical safety studies, a crucial aspect of drug development. The platform integrates digital protocols and standard operating procedures (SOPs) to facilitate scheduling and resource planning, ensuring that studies are conducted efficiently and in compliance with regulatory requirements. By integrating in-life and bioanalytical data, SIMS enables the computation of concordance and treatment-relatedness signals as data is collected, providing valuable insights into study outcomes.

One of the key features of SIMS is its ability to assist Study Directors in drafting study reports, with the system generating submission-quality SEND datasets in real-time, allowing for immediate review and submission. This capability not only accelerates the reporting process but also ensures that the data supporting the study conclusions is up-to-date and traceable to the raw data collected during the study.

PointCross Life Sciences, which has been supporting CROs and sponsors since 2007, has developed SIMS to meet the evolving needs of the industry. The platform is designed to handle the increasing demands of new approach methodologies (NAMs), the development of virtual control groups, and innovative study designs, all while maintaining compliance with regulatory frameworks such as GLP (21 CFR Part 58, OECD) and 21 CFR Part 11 audit trails and e-signatures.

The system's integration with PointCross' Single Track™, a tool that identifies treatment-relatedness for each marker on every subject, further enhances the platform's capabilities. Single Track™ 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. This integration ensures that the Study Director’s judgments are supported by the system’s data analysis, but the final determinations of biological significance, adversity, and NOAEL/NOEL remain with the Study Director, maintaining the integrity of the study’s conclusions.

SIMS is a modern study data management system that extends beyond data collection, empowering sponsors with access to their digitized study data. This capability allows for improved operational agility and digital traceability, which are essential in today’s fast-paced and increasingly data-intensive pharmaceutical and biotech industries.

PointCross Life Sciences is positioning SIMS as a critical tool for CROs and sponsors looking to evolve beyond legacy laboratory information management systems (LIMS) and traditional spreadsheet-based collection methods. The company claims that SIMS can help CRO operations recapture margin and sponsors accelerate program timelines, making it a valuable asset in the ongoing digital transformation of preclinical study operations.

The digital transformation of preclinical study operations is a significant development in the pharmaceutical and biotech industry, and SIMS represents a significant step forward in this evolution. By providing a comprehensive, integrated platform for planning, conducting, analyzing, and reporting nonclinical safety studies, SIMS is poised to play a crucial role in the future of drug development and regulatory compliance.