What Project Data Sphere does

Project Data Sphere operates an open-access oncology data sharing platform and a set of closed-access precompetitive research programs, functioning as an independent 501(c)(3) subsidiary of the CEO Roundtable on Cancer (CEORT). The open-access platform houses 252+ de-identified clinical trials and 250,000+ patient records, made available to qualified researchers worldwide at no cost. Closed-access precompetitive projects convene pharmaceutical companies, academic institutions, the FDA, and technology partners around jointly developed AI-driven oncology tools, including autoRECIST (a deep learning system for RECIST 1.1 tumor assessment shown to reduce inter-radiologist variability by approximately 30%), the Total Tumor Burden Index (a volumetric 3D tumor quantification model), and AI-enabled tools within the 2017-launched Immune-Related Adverse Events (irAEs) Initiative. The irAEs Initiative further incorporates the ASPIRE physician community, the STORIES patient community, and has driven the establishment of new ICD-10-CM codes for immunotherapy safety reporting through FDA collaboration.

The business model is that of a 501(c)(3) nonprofit: the platform is offered free of charge to academic and clinical researchers, with no disclosed pricing for data access or tool usage. Revenue, where it exists, derives from member organizations, philanthropic donations, and pharma/industry partnership contributions supporting the mission rather than from direct commercial software sales. The go-to-market is a community-led, precompetitive model — engagement is driven through the parent CEO Roundtable on Cancer's 500+ Gold Standard accredited organizations, 11 FDA-PDS Symposia, FDA Grand Rounds presentations, and thought-leadership channels including the Precision Signals podcast and active social media presence. The primary "customers" in practice are research collaborators and contributing institutions rather than revenue-paying buyers, which distinguishes PDS from commercial oncology analytics vendors.

Name

Project Data Sphere

Legal name

Project Data Sphere

Website

https://ceoroundtableoncancer.org

Company type

Private

Founded year

2001

Operating status

Operating

Headcount range

1–10 employees

Short description

Project Data Sphere operates an oncology data sharing platform and precompetitive research programs, serving pharmaceutical companies, academic institutions, the FDA, and technology partners with 252+ de-identified clinical trials, AI-driven oncology tools including autoRECIST, and the global irAEs Initiative.

Ownership category

akta.pro rank

Product category

Oncology Clinical Research Data Platform

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417), Software Publishers (51321)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Computer Programming, Data Processing, Etc. (7370)

akta.pro primary industry

Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM)

akta.pro secondary industries

Scientific Data Management & Data Platforms (SDMS/Data Lakehouse for R&D) (HLAGAJAC), Biostatistics, Statistical Computing & Clinical Programming (SAS/R/Pipelines) (HLACAOAO)

Keywords

• Oncology data sharing
• Clinical trial platform
• Precompetitive cancer research
• AI tumor assessment
• Medical imaging analytics

Headquarters

HQ city

Cary

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

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

Revenue model

1. Nonprofit Operations: Project Data Sphere operates as a 501(c)(3) nonprofit subsidiary of the CEO Roundtable on Cancer. Revenue appears to come from organizational membership, donations, and potentially pharmaceutical/industry partnerships supporting the mission. The platform offers open-access data sharing at no cost to researchers.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Project Data Sphere operates an open-access oncology data-sharing platform hosting 252+ clinical trials and 250,000+ de-identified patient records, paired with AI-driven research tools (e.g., autoRECIST) and named precompetitive research programs that enable pharmaceutical companies, academic researchers, regulators, and technology partners to conduct collaborative cancer research.

Product overview

Project Data Sphere operates as an independent 501(c)(3) subsidiary of the CEO Roundtable on Cancer, offering two complementary programs: an open-access data sharing platform housing 252+ de-identified clinical trials and 250,000+ patient records, and closed-access precompetitive research projects enabling collaboration between pharma, academia, the FDA, and technology partners on AI-driven oncology tools. The portfolio includes autoRECIST (deep learning-powered tumor assessment automation), the Total Tumor Burden Index (volumetric 3D tumor quantification), the irAEs Initiative (immune-related adverse events research with AI tools), ASPIRE and STORIES communities, and the Precision Signals Podcast—all unified under the mission to accelerate cancer research through data sharing and AI-powered oncology tools.

Differentiator

Problem solved

Functional benefit

Brands

• autoRECIST: Deep learning-powered automation of RECIST 1.1 tumor assessments—reducing ~30% inter-radiologist variability.
• Total Tumor Burden Index (TTBI)
• Immune-Related Adverse Events (irAEs) Initiative
• Precision Signals Podcast

Quantifiable outcome

• Reduces inter-radiologist variability in RECIST 1.1 tumor assessments by approximately 30%
• +1 more outcomes

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature3 records

Partnerships

Four partnerships are on record, tiered core.

• FDAcoreStrategic or Co-development PartnerFDA collaborates with Project Data Sphere on multiple initiatives including: AI-driven tumor assessment validation (autoRECIST presented at FDA Research Grand Rounds), establishment of ICD-10-CM codes for immune-related adverse events, and hosting of 11 FDA-PDS Symposia. The FDA is a key partner in precompetitive research projects and harmonized clinical trial reporting standards development.
• Pharmaceutical CompaniescoreStrategic or Co-development PartnerPharma companies participate in closed-access precompetitive research projects through Project Data Sphere, collaborating on AI-driven oncology tools development. They also contribute clinical trial data to the open-access platform and benefit from shared analysis capabilities.
• Academic InstitutionscoreStrategic or Co-development PartnerAcademic researchers access the open-access data platform and collaborate on precompetitive oncology research alongside pharma, FDA, and technology partners. Academic institutions contribute expertise and research capabilities to joint AI tool development initiatives.
• Technology PartnerscoreTechnology or IntegrationTechnology partners collaborate on AI-driven oncology tool development, providing technical infrastructure and AI/ML capabilities. These partnerships enable the development of tools like autoRECIST and TTBI, combining domain expertise in oncology with advanced technology capabilities.

Scale indicators6 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Vivli: Vivli operates a clinical research data sharing platform enabling anonymized IPD sharing across sponsors and academic researchers. Like PDS, it focuses on precompetitive data exchange and is mission-aligned, but covers multiple therapeutic areas beyond oncology.
• Sage Bionetworks: Sage Bionetworks is a nonprofit research organization that builds open-data platforms (e.g., Synapse) and runs precompetitive consortia for biomedical data sharing and analysis. Comparable to PDS in mission, nonprofit structure, and emphasis on collaborative analytics infrastructure.
• Yale Open Data Access (YODA) Project: YODA Project facilitates responsible sharing of clinical trial data with external investigators, mirroring PDS's mission of making de-identified trial data broadly available for independent research. Both operate as neutral data-sharing intermediaries rather than commercial analytics vendors.

Emerging players

• Flatiron Health: Flatiron aggregates oncology real-world data from EHRs and partners with academia and pharma for research. While primarily commercial and focused on real-world (not trial) data, it shares PDS's oncology focus and emphasis on structured, research-grade datasets.
• COTA Healthcare: COTA curates oncology real-world data and analytics for providers and life sciences. Like PDS, it is oncology-focused and data-centric, but emphasizes real-world evidence rather than clinical trial data sharing.
• Tempus AI: Tempus builds oncology data and AI platforms combining molecular and clinical data for precision medicine. Comparable to PDS in applying AI to oncology data at scale, but operates commercially with much broader molecular profiling and clinical-decision offerings.
• Foundation Medicine: Foundation Medicine provides genomic profiling and partners with pharma on oncology data initiatives. It overlaps with PDS in oncology data collaboration with pharma and FDA, though focused on molecular rather than clinical trial data.

Broad incumbents

• Medidata (Dassault Systèmes): Medidata provides industry-leading EDC, CTMS, and clinical trial analytics used by most major sponsors. As a broad incumbent in clinical trial informatics, it overlaps with PDS in trial data management but operates commercially at much larger scale and lacks a nonprofit, open-access model.
• Veeva Systems: Veeva offers life sciences cloud software including CTMS, eTMF, and clinical data solutions used across pharma R&D. Comparable as a life-sciences data/informatics platform, but commercially focused and far broader in scope than PDS's oncology-specific mission.
• IQVIA: IQVIA is a global leader in clinical research services and life sciences analytics, with deep pharma relationships and proprietary trial/real-world data assets. Comparable in serving pharma oncology research needs, but commercial, end-to-end, and far larger in scale than PDS.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/ceocancerfight
• YouTubeyoutube.com/@PrecisionSignals
• LinkedInlinkedin.com/company/project-data-sphere-llc

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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

Frequently asked questions about Project Data Sphere