Pointcross Life Sciences

PointCross Life Sciences is a specialized software and services company delivering a comprehensive Clinical Data Automation Platform (CDAP) for the global BioPharma industry. The company serves pharmaceutical sponsors, contract research organizations (CROs), and life sciences organizations by streamlining all aspects of clinical and nonclinical data management, standardization, regulatory submission, and advanced analytics. PointCross solutions are designed to be compliant with CDISC, SEND, SDTM, ADaM, and FDA standards, supporting both IND, NDA, and BLA preparation workflows.

At the core of PointCross offerings is the XBIOM™ platform, a fully integrated Clinical Data Automation Platform that is now RAG-enabled with AI and Large Language Model (LLM) technology. XBIOM deploys secure LLMs within corporate firewalls alongside protected study data, enabling Retrieval Augmented Generation (RAG) capabilities that allow users to query stored clinical trial and nonclinical study data through plain English via a chat interface. This approach protects proprietary trial information from exposure to external or cloud-hosted AI services while making data accessible to both experienced researchers and new users without specialized training.

XBIOM™ Platform Modules

• XBIOM™ VDR, Study Data I/O, and Curation: Ingests, exchanges, and curates study data from any source, including Electronic Data Capture (EDC) systems, biomarker data from labs, and CROs, feeding into the Universal Data Model (UDM) repository.
• XBIOM™ MDR and Smart Transformer: Provides a Meta Data Repository and automated smart transformation for all source and destination standards, including terminology harmonization across clinical and nonclinical data.
• XBIOM™ UDM Repository: A Universal Data Model and future-proofed repository indexed for query masks and instant search, offering secure and scalable data warehousing.
• XBIOM™ Regulatory Submission: Automates the generation of submission-ready SDTM, ADaM, and Tables, Figures, and Listings (TFLs), and includes the eDataValidator™, a Statistical Computing Environment (SCE) with R and Python programming, and an interface to SAS.
• XBIOM™ Nonclinical Insights: Delivers analytics and visualization for all nonclinical studies sourced from LIMS, SEND datasets, biomarker lab assays, or bio-analytics platforms.
• XBIOM™ Clinical Insights: Provides analytics and visualization on searchable stratified cohorts, on-demand or SAP-driven statistical analysis, templated and custom plots and tabulations, and annotated TFL objects.
• XBIOM™ IGO (Immersive Graphics Object): An integrated visualization application for generating tables, listings, and figures for research and publication purposes.
• eDataValidator (eDV): Offers limitless validation of clinical SDTM and ADaM as well as nonclinical SEND datasets, serving as a single solution for IND, NDA, and BLA preparation.
• Single Track Processing: An AI-augmented approach that simultaneously produces compliant study reports and submission-ready SEND datasets from a single governed data source, delivering both within 2–3 weeks after data lock with reported 30–50% cost savings.

Solutions and Services

• SEND Services: Includes SEND dataset preparation, SEND-ASSURE quality control of SEND datasets, and SEND quote generation for nonclinical regulatory submissions.
• Digital Study Report (DSR) Generation: Automated generation of digital study reports for nonclinical safety studies.
• Interim Monitoring of Nonclinical Studies: Ongoing monitoring and oversight of nonclinical study data compliant with applicable regulatory standards.
• Interim Monitoring of Clinical Trials: Interim study monitoring services for clinical trials in compliance with CDISC, PDMA, and FDA standards.
• Automated SDTM Generation from EDC: Streamlined, automated conversion of EDC data into submission-ready SDTM datasets.
• Biosample Tracking for Specialty Assays: Tracking and management of biosamples used in specialty assay workflows.
• Clinical or Nonclinical Repository: Centralized, secure data repository solutions for both clinical and nonclinical study data.

Data Standardization and Quality Assurance Services

• SEND standardization for nonclinical studies
• SDTM and ADaM standardization for clinical studies
• Biomarker assay data standardization
• SEND ASSURE quality control and corrections services
• Data Concierge (Data as a Service) for both nonclinical and clinical and translational data
• Digitization, analysis, and warehousing of legacy clinical trial data

Core Platform Capabilities

• Efficient data management and curation for clinical and nonclinical datasets
• Future-proofed, secure, and scalable data warehousing
• Standardization and harmonization to ensure compliance with regulatory submission standards
• Advanced analytics and visualization to transform data into actionable insights
• Significant reduction in programming efforts for CROs and sponsors, optimizing processes and enhancing productivity

Compliance, Deployment, and Industry Engagement

• Compliant with CDISC, SEND, SDTM, ADaM, PDMA, and FDA regulatory standards
• Secure on-premise and firewall-protected deployment options to safeguard proprietary trial data
• AI LLM integration deployed within corporate firewalls, ensuring no exposure of sensitive data to external cloud-hosted AI services
• Active participation in industry events including the Society of Toxicology (SOT) Annual Meeting and ToxExpo
• Webinar programming covering topics such as automating study reports and SEND integration in nonclinical safety studies
• Established partner network and commitment to quality, information security, and data privacy policies

PointCross combines deep regulatory expertise with advanced automation and AI-driven technology to help BioPharma organizations accelerate their data workflows, reduce costs, and maintain compliance across the full lifecycle of clinical and nonclinical research.