Clinical Research Data Sharing Alliance

What Clinical Research Data Sharing Alliance does

Clinical Research Data Sharing Alliance (CRDSA) is a non-profit consortium founded in 2021 and headquartered at c/o Genentech in South San Francisco, California, with a secondary presence in Piscataway, New Jersey. Its stated mission is to make clinical research data easy to share and easy to use. CRDSA convenes a multi-stakeholder membership spanning large biopharma sponsors (Amgen, AstraZeneca, Genentech, Roche, Takeda, IQVIA), academic medical centers (Duke Clinical Research Institute, University of Chicago, Flinders University), data intermediaries (Vivli, Project Data Sphere, Critical Path Institute), disease foundations (Michael J. Fox Foundation), and international bodies (Health Data Research UK, GA4GH, Data for the Common Good), and operates with approximately 14 employees.

CRDSA's core outputs are industry standards, assessment tooling, and increasingly AI-enabled software. Its standards portfolio includes CRDSA Std 1001 (Sharing Clinical Study Data) and CRDSA Std 2001 (Secondary Analysis of Clinical Study Data), both published in September 2024. It also publishes a free Data Sharing Assessment App, a Data Sharing Technology Assessment Framework built in R Shiny, and an External Controls white paper (October 2025). Its flagship technical product, Project Concordia, launched in February 2026, is an agentic AI data harmonization platform using autonomous agents and RAG-enhanced retrieval, validated on 16 trials across 11 sponsors covering approximately 7,000 patient records. CRDSA also operates AI Advisory Communities and technical work groups, and engages directly with FDA, EMA, and MHRA on data sharing policy.

The business model is membership-driven: for-profit members pay tiered annual dues ranging from $7,500 to $40,000, individual contributors pay $250 per year, and nonprofit and academic participants join free. With 15+ named member organizations and a 14-person staff, CRDSA operates at consortium scale rather than commercial SaaS scale, and its strategic positioning combines standards-body authority, applied AI tooling, and regulatory engagement to shape clinical research data sharing practices globally. Its tools and standards have reached 90+ countries with 27,000+ downloads, and the June 2025 GA4GH strategic partnership extends the alliance into the international genomics community.

Name

Clinical Research Data Sharing Alliance

Legal name

Clinical Research Data Sharing Alliance

Website

https://crdsalliance.org

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

11–50 employees

Ownership category

akta.pro rank

Product category

Clinical Research Data Sharing

NAICS

Professional Organizations (81392), Business, Professional, Labor, Political, and Similar Organizations (8139), Business Associations (813910), Scientific Research and Development Services (5417)

SIC

Services-Membership Organizations (8600), Services-Computer Programming, Data Processing, Etc. (7370)

akta.pro primary industry

Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF)

Keywords

• Clinical data sharing
• Data harmonization
• Healthcare data standards
• AI data platform
• Clinical research

Headquarters

HQ city

Piscataway, New Jersey

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Membership Dues: Annual membership dues from for-profit companies tiered by employee count. Four tiers ranging from $7,500 to $40,000 annually based on organization size.
2. Individual Membership Fees: Individual contributor memberships billed at $250 per year on anniversary date.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels6 records

Core offering

CRDSA is a multi-stakeholder nonprofit alliance that advances clinical research data sharing through published standards (CRDSA Std 1001 and Std 2001), assessment tools (Data Sharing Assessment App and Data Sharing Technology Assessment Framework), and the development of Project Concordia, an agentic AI platform for clinical data harmonization. The organization operates as a member consortium funded by tiered membership dues, providing collaborative governance and resources to biopharma, academic, nonprofit, and technology partners.

Product overview

CRDSA is a multi-stakeholder nonprofit alliance that develops a platform-plus-standards approach to clinical research data sharing. The flagship initiative is Project Concordia, an agentic AI platform that delivers clinical data harmonization as scalable infrastructure. Supporting this core platform are published standards (CRDSA Std 1001 and Std 2001), assessment tools (Data Sharing Assessment App and Data Sharing Technology Assessment Framework), and collaborative work groups and AI Advisory Communities. Together these products and programs address the end-to-end process of clinical data sharing from standards development through data harmonization to secondary research use.

Differentiator

Problem solved

Functional benefit

Brands

• Project Concordia: CRDSA's flagship initiative - a purpose-built agentic AI platform to deliver clinical data harmonization as scalable infrastructure, transforming months of manual data management into an auditable, reproducible pipeline.

Products and services

• Project Concordia - Agentic AI Data Harmonization Platform A purpose-built agentic AI platform that delivers clinical data harmonization as scalable infrastructure. It uses autonomous AI agents with orchestration and retrieval pipelines to transform months of manual data management into auditable, reproducible pipelines running in hours. Validated prototype covers Demographics Domain with 16 trials, 11 sponsors, and approximately 7,000 patient records. Targeted at biopharma sponsors, academic researchers, and platform partners in the clinical research ecosystem.
• CRDSA Std 1001: Standard for Sharing Clinical Study Data Standard (v1.0) published September 2024 that promotes data completeness, consistency, interoperability, and information transparency for clinical study data sharing. Used by biopharma sponsors, academic institutions, and data platforms to standardize how clinical study data is shared for secondary research.
• CRDSA Std 2001: Standard for Secondary Analysis of Clinical Study Data Standard (v1.0) published September 2024 that helps researchers conduct robust analyses and objectively interpret findings generated from the use of shared patient data. Targeted at researchers, biostatisticians, and data scientists performing secondary analyses on shared clinical trial data.
• Data Sharing Assessment App A 15-question scored rubric designed to objectively measure the completeness and quality of a proposed data sharing plan, commitment, or data contribution. Translates principles from CRDSA's Standard for Sharing Clinical Study Data into a structured instrument. Available free to data contributors, researchers, and platform owners.
• Data Sharing Technology Assessment Framework Framework to help data contributors, platform owners, and researchers determine the requirements and use cases important to their data-sharing initiatives. Available as R Shiny web application and Excel-based tool. Used by organizations evaluating technologies for clinical data sharing programs.

Quantifiable outcome

• Resource downloads: 27,000+
• +3 more outcomes

Named customers15 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability4 records

Feature4 records

Partnerships

One partnership is on record.

• Global Alliance for Genomics and Health (GA4GH)coreStrategic or Co-development Partner · 1 June 2025CRDSA and GA4GH agreed to a Strategic Partnership in June 2025. As organizations sharing passion in developing standards for clinical research data sharing, the mutual collaboration aims to foster greater progress in the data sharing community. Both organizations develop standards that advance data sharing practices.

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Health Data Research UK (HDR UK): UK-based national health data research institute and CRDSA member. Both convene multi-stakeholder communities around clinical and health data interoperability with overlapping academic and regulatory engagement.
• ClinicalStudyDataRequest.com (CSDR): Industry-led clinical trial data request platform pioneered by GSK and now used by multiple sponsors. CRDSA's senior advisor Andrew Freeman led the program at GSK that created CSDR and Vivli, making it a direct predecessor and adjacent platform.
• Global Alliance for Genomics and Health (GA4GH): International standards organization for genomic and health data sharing. As of June 2025, GA4GH and CRDSA operate under a strategic partnership, jointly advancing data sharing standards with overlapping membership and complementary domains.
• MRCT Center of Brigham and Women's Hospital and Harvard: Multi-stakeholder convener focused on clinical research ethics, transparency, and data sharing. CRDSA board member Rebecca Li previously led MRCT, and both organizations influence clinical trial data sharing practice through standards and policy work.
• Yale Open Data Access (YODA) Project: Clinical trial data sharing platform operated by Yale University. YODA and CRDSA both broker access to clinical study data for secondary research and compete for sponsor participation and methodology credibility.
• CDISC: Standards body for clinical research data. CRDSA's Std 1001 and Std 2001 sit alongside CDISC's data standards (CDASH, SDTM, ADaM); both compete for influence over how clinical trial data is structured and shared.
• Vivli: Clinical research data sharing platform and CRDSA member organization. Vivli operates a data sharing ecosystem for individual participant-level clinical trial data; CRDSA develops complementary standards and AI harmonization tooling for the same ecosystem.
• Critical Path Institute (C-Path): Independent nonprofit focused on regulatory science and data sharing, and a CRDSA member. C-Path develops data platforms and regulatory-grade methodologies overlapping with CRDSA's secondary use and external controls work.
• Project Data Sphere: Independent CEO Roundtable on Cancer initiative for oncology data sharing, and a CRDSA member. Both organizations operate in the clinical trial data sharing space with overlapping sponsor constituents.
• TransCelerate BioPharma: Nonprofit biopharma consortium focused on clinical trial collaboration, including data sharing initiatives. CRDSA's CEO previously led TransCelerate's COVID-19 patient-level data sharing program, and both organizations convene pharma sponsors around shared clinical research infrastructure.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/@CRDSAlliance
• LinkedInlinkedin.com/company/crdsa

Revenue estimate

Valuation estimate

Number of profiles

Profiles16 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Clinical Research Data Sharing Alliance