What PointCross Life Sciences does

PointCross Life Sciences is a privately held software company that provides AI-augmented clinical and nonclinical data automation platforms for pharmaceutical sponsors and contract research organizations. The company's core focus is regulatory-grade data standardization and submission, with particular depth in SEND (Standard for Exchange of Nonclinical Data) preparation for the FDA and PMDA. PointCross serves more than 500 sponsor and CRO organizations globally — including 5 of the top 15 pharmaceutical companies and major CROs such as IQVIA and ICON — and claims to power approximately 25% of FDA SEND submissions with a stated record of zero technical rejections.

The company's technology foundation is the Xbiom platform, a modular, AI-augmented data automation system built on machine learning, a proprietary Universal Data Model (UDM), and now RAG-enabled Large Language Model capabilities deployed within customer firewalls. Xbiom modules span the full data lifecycle: VDR for ingestion and curation, MDR (Smart Transformer) for metadata governance, UDM for unified analysis-ready storage, Regulatory Submission packaging for SDTM/ADaM/TFL, Nonclinical Insights and Clinical Insights for analytics, and IGO for publication-quality visualization. The flagship Single-Track Processing workflow generates compliant Study Reports and SEND datasets simultaneously from one data stream, compressing a traditional 10-week sequential timeline to 2–3 weeks and delivering 30–50% cost savings. The platform is ISO/IEC 27001:2022 and SOC 2 Type II certified and complies with EU GDPR, CalOPPA, and COPPA, supporting enterprise deployments.

PointCross generates revenue through three streams: monthly or annual SaaS subscriptions for the cloud-hosted Xbiom platform and the standalone eDataValidator product (publicly listed at $170 per user per month with volume discounts), on-premise software licenses for enterprises requiring in-environment deployment, and professional services including SEND dataset generation, SEND-ASSURE quality checks, interim study monitoring, automated SDTM and Digital Study Report generation, and Data Concierge managed services. Distribution combines direct enterprise field sales targeting pharma sponsors and CROs with a strategic channel partnership — most notably the 2024 Hexaware Technologies alliance for Clinical Data Automation as a Solution (CDaaS) — plus active participation in industry standards bodies (Platinum CDISC member, PHUSE contributor) and conferences (SOT, PHUSE Connect, Tri-Con, Bio-IT World). The company is headquartered in Foster City, California, with offices in Silver Spring (MD), Paris, Shanghai (APAC), and an engineering subsidiary in Bangalore, India.

Name

PointCross Life Sciences

Legal name

PointCross Life Sciences Inc.

Website

https://pointcrosslifesciences.com

Company type

Private

Founded year

2009

Operating status

Operating

Headcount range

51–100 employees

Short description

PointCross Life Sciences provides AI-augmented clinical and nonclinical data automation software for pharma sponsors and CROs, focused on SEND dataset preparation, regulatory submission packaging, and metadata management to support FDA and PMDA compliance.

Ownership category

akta.pro rank

Product category

Clinical Data Automation Software

NAICS

Custom Computer Programming Services (541511), Other Scientific and Technical Consulting Services (541690), Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Regulatory Information Management (RIM) & Submission Publishing Software (HLAGAJAL)

akta.pro secondary industries

Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM), Biostatistics, Statistical Computing & Clinical Programming (SAS/R/Pipelines) (HLACAOAO), Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)

Keywords

• Clinical data automation
• SEND dataset generation
• Nonclinical data standardization
• Regulatory submission software
• Drug safety informatics

Headquarters

HQ city

Foster City

HQ country

United States

HQ region

North America

Offices5 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Infrastructure, Operations, Marketing or Sales

Revenue model

1. SaaS Software Subscriptions: Monthly subscription-based access to Xbiom platform and eDataValidator, delivered as cloud-hosted SaaS with optional desktop companion tools.
2. Professional Services: SEND dataset generation services, SEND-ASSURE quality checks, data standardization services (SDTM, ADaM, SEND), interim study monitoring, and data concierge services.
3. On-Premise Software Licenses: On-premise installations of eDataValidator for organizations requiring integrated, qualified validated workflows subject to SOPs, with API integration capabilities.

Pricing tiers

Go-to-market motion3 records

Distribution channels4 records

Marketing channels7 records

Core offering

PointCross Life Sciences develops and sells the Xbiom™ Clinical Data Automation Platform, an AI-augmented SaaS solution for nonclinical and clinical data management targeting pharmaceutical sponsors and Contract Research Organizations. Core functionality includes SEND dataset generation, SDTM and ADaM standardization, automated Study Report generation, metadata management, conformance validation (eDataValidator), and regulatory submission packaging with full traceability from raw data through FDA/PMDA submissions. The company also provides professional services for SEND generation, quality assurance (SEND-ASSURE), Data Concierge managed services, and biosample tracking.

Product overview

PointCross Life Sciences offers a unified Clinical Data Automation Platform (CDAP) called XBIOM™ for the global BioPharma industry. The platform uses a modular, Lego-block architecture consisting of interconnected modules: XBIOM™ VDR for data ingestion and exchange, XBIOM™ MDR for metadata repository and Smart Transformation, XBIOM™ UDM for unified data model repository, XBIOM™ Regulatory Submission for automated SDTM/ADaM/TFL generation, XBIOM™ Nonclinical Insights and XBIOM™ Clinical Insights for analytics, XBIOM™ IGO for visualization, and eDataValidator for validation. The flagship Single Track Processing capability uses AI to automatically generate both Study Reports and SEND datasets from a single unified data source in 2-3 weeks. Complementary services include SEND Dataset Generation, SEND-ASSURE quality checks, Digital Study Report Generation, Automated SDTM Generation, Data Concierge services, and Biosample Tracking. The platform is now RAG-enabled with AI LLM technology for plain English data queries.

Differentiator

Problem solved

Functional benefit

Brands

• Xbiom™: The Clinical Data Automation Platform - AI-augmented platform for clinical and nonclinical data management, automating study reports, SEND datasets, SDTM generation, and regulatory submissions.
• SEND-ASSURE
• eDataValidator™ (eDV)
• Single Track Processing
• Xbiom™ VDR
• Xbiom™ MDR (Smart Transformer)
• Xbiom™ UDM
• Xbiom™ Regulatory Submission
• Xbiom™ Nonclinical Insights
• Xbiom™ Clinical Insights
• Xbiom™ IGO
• CDaaS

Products and services

• XBIOM™ Solutions Platform End-to-end AI-augmented Clinical Data Automation Platform sold as cloud-hosted SaaS or on-premise installation for pharma sponsors and CROs. Provides modular architecture with AI LLM-powered RAG-enabled data access for clinical and nonclinical data management, supporting study reports, SEND datasets, SDTM/ADaM generation and regulatory submissions.
• XBIOM™ Single Track Processing AI-augmented processing capability for CROs and sponsors that automatically generates both compliant Study Reports and SEND datasets simultaneously from a single unified data source, delivering both outputs in 2-3 weeks after data lock with 30-50% cost savings versus traditional 10-week sequential workflows.
• eDataValidator (eDV) Standalone validation tool for SDTM, ADaM and SEND datasets against CDISC standards, FDA Technical Rejection Criteria and PMDA validation rules. Sold as a cloud subscription at $170/month/user with volume discounts or as an on-premise per-seat license, with API integration for enterprise SOPs.
• SEND Dataset Generation Service Professional service for preparing and generating SEND (Standard for Exchange of Nonclinical Data) datasets compliant with FDA requirements, including Trial Summary and Trial Design domains from protocol metadata. Offered to pharma sponsors and CROs needing outsourced SEND deliverables.
• SEND-ASSURE Quality Assurance Service Quality assurance service for SEND datasets ensuring conformance, consistency and quality prior to FDA submission. Performs 100% consistency checks against nonclinical study reports to identify discrepancies before regulatory submission.
• Digital Study Report (DSR) Generation AI-powered professional service for auto-generation of compliant nonclinical and clinical study reports from raw data. Generates draft report text and summary tables from annotated study signals within a CFR Part 11-compliant environment, with study director review before finalization.
• Automated SDTM Generation from EDC Professional service offering automated conversion of EDC data to SDTM-ready datasets using metadata-driven workflows with AI-augmented auto-mapping capability, supporting efficient clinical data transformation for pharma sponsors and CROs.
• Data Concierge (Data as a Service) Managed data services for nonclinical, clinical and translational data management, conversion and standardization. Includes digitization, analysis and warehousing of legacy clinical trial data, delivered as outsourced data operations for sponsors and CROs.
• Biosample Tracking for Specialty Assays Specialty biosample tracking and management service across specialty and translational assays. Integrates with LIMS, biomarker labs and other data sources to provide comprehensive biosample lifecycle management for translational medicine workflows.
• Clinical or Nonclinical Repository Centralized repository offering to store, search and visualize study data across clinical and nonclinical studies, powered by the Xbiom Universal Data Model. Used by sponsors and CROs to harmonize data across multiple trials and enable cross-study analytics.

Quantifiable outcome

• 30-50% cost savings per nonclinical study compared to traditional sequential workflow
• +5 more outcomes

Named customers13 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

Yes

API docs

API detail

Core technology

AI maturity

App detail

AI capability7 records

Feature7 records

Partnerships

Five partnerships are on record, tiered core, minor and major.

• Hexaware TechnologiescoreChannel Partner/ Reseller/ Distributor · 21 October 2024Strategic partnership where Hexaware launched Clinical Data Automation as a Solution (CDaaS) powered by PointCross' Xbiom platform. This collaboration enables Hexaware to offer PointCross's data automation capabilities to their broad range of pharma sponsor customers, combining Hexaware's clinical solutions expertise with PointCross's data automation platform for enhanced data accuracy, compliance, and operational efficiency.
• InterpretOmicsminorStrategic or Co-development PartnerStrategic partnership for clinical and genomic biomarker management for drug development, enabling integration of genomic biomarker data with clinical trial data within the Xbiom platform.
• CAC EXICAREminorImplementation/ SI/ Consulting PartnerStrategic implementation partnership for pharma and biotech companies in Japan to support CDISC implementation using PointCross solutions.
• Amazon Web Services (AWS)coreTechnology or IntegrationPartnership for joint workshops on biomarker and translational research. PointCross leverages AWS cloud infrastructure for SaaS delivery of Xbiom platform, with AWS hosting and data protection agreements compliant with EU GDPR requirements.
• RochemajorStrategic or Co-development PartnerJoint collaboration with Roche on utilizing SEND data potential for three main business cases: real-time study monitoring, simultaneous report and SEND data review, and cross-study analysis. Developed RoDEo user interface for integrated SEND data utilization.

Scale indicators10 records

Recent moves5 records

Expansion highlights6 records

Emerging players

• Dotmatics: Dotmatics offers a scientific data platform spanning R&D informatics, with emerging presence in clinical and translational data workflows that increasingly overlap with Xbiom's analytics modules.
• TetraScience: TetraScience provides a scientific data cloud for life sciences R&D with AI/ML capabilities, competing in the same 'data harmonization plus AI' lane as Xbiom UDM, particularly for translational and biomarker data.

Broad incumbents

• Medidata Solutions (Dassault Systèmes): Medidata's Rave EDC, eCOA, and Clinical Data Studio compete with Xbiom's clinical SDTM/ADaM and trial data management offerings as part of a much broader clinical trial technology suite.
• Oracle Health Sciences: Oracle's Clinical One and InForm EDC platforms compete with Xbiom in clinical trial data capture and submission automation, with deeper enterprise reach and integration into Oracle's broader health stack.
• Certara: Certara combines regulatory software and scientific consulting services, with overlaps in regulatory submission technology and life sciences data analytics — adjacent to PointCross's SEND and submission automation capabilities.
• ArisGlobal: ArisGlobal's LifeSphere platform covers regulatory, safety, and clinical data workflows for pharma, overlapping with PointCross's RIM and regulatory submission capabilities.
• Veeva Systems: Veeva's Vault CDB and Vault EDC platforms offer clinical and regulatory data management at scale. While broader in scope, Veeva competes with PointCross in clinical SDTM/ADaM submissions and CRO workflow automation.
• SAS Institute: SAS's Clinical Trials Data Transformation and biostatistics platforms overlap with PointCross's SDTM/ADaM/TFL offerings. Xbiom Regulatory Submission explicitly supports SAS interfaces, indicating SAS as both partner and competitor.
• MasterControl: MasterControl's quality and regulatory information management platform overlaps with PointCross's regulatory submission and SEND-ASSURE quality assurance capabilities within pharma quality workflows.

Direct peers

• Instem: Instem provides SEND/preclinical software solutions and study data management platforms for life sciences. It is the most direct competitor to PointCross's nonclinical SEND and study reporting offerings.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/pointcross_ls
• YouTubeyoutube.com/user/PointCrossInc
• LinkedInlinkedin.com/company/pointcross-life-sciences

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about PointCross Life Sciences