clinical research data sharing alliance
The Clinical Research Data Sharing Alliance is a multi-stakeholder nonprofit consortium that develops technical standards, frameworks, and AI tooling (notably the Project Concordia agentic AI platform) to enable responsible sharing of clinical research data among biopharma, academia, nonprofits, technology vendors, and regulators.
- Company typePrivate
- Founded2021
- HeadquartersSouth San Francisco, United States
- Headcount1–10
- GTM typeB2B
- OfferingSoftware
What clinical research data sharing alliance does
The Clinical Research Data Sharing Alliance (CRDSA) is a multi-stakeholder nonprofit consortium established in 2021 that convenes biopharmaceutical companies, academic institutions, nonprofit organizations, data-sharing platforms, technology companies, and regulators to advance responsible sharing of clinical research data. Headquartered c/o Genentech in South San Francisco, CA, the alliance operates with a small staff of 1-10 employees under CEO Aaron Mann and Co-founder Virginia Nido, with board representation from major life sciences organizations including Amgen, AstraZeneca, Roche, Takeda, Novartis, and Parexel.
CRDSA's core deliverables include published technical standards (CRDSA Std 1001 and CRDSA Std 2001), a Data Sharing Assessment App, a Data Sharing Technology Assessment Framework, and an External Controls white paper. Its most technically ambitious product is Project Concordia, an agentic AI platform that uses retrieval-augmented generation (RAG)-enhanced pipelines and multi-step AI agents to harmonize clinical study data across formats and sponsors; a working prototype has been validated against 16 trials across 11 sponsors covering approximately 7,000 patient records. The alliance's resources have been downloaded over 27,000 times across more than 90 countries, indicating broad geographic reach relative to its operating scale.
The organization operates a tiered membership model: for-profit members pay between $7,500 and $40,000 depending on tier, individual memberships cost $250, and nonprofit and academic participation is free. CRDSA has established a strategic partnership with the Global Alliance for Genomics and Health (GA4GH) and convenes an annual summit alongside AI Advisory Communities that shape cross-sector working groups on data sharing.
clinical research data sharing alliance firmographics
Firmographics- 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
- 1–10 employees
- Short description
- The Clinical Research Data Sharing Alliance is a multi-stakeholder nonprofit consortium that develops technical standards, frameworks, and AI tooling (notably the Project Concordia agentic AI platform) to enable responsible sharing of clinical research data among biopharma, academia, nonprofits, technology vendors, and regulators.
- Ownership category
- akta.pro rank
clinical research data sharing alliance industry classification
Industry- Product category
- Clinical Research Data Sharing
- NAICS
- Business Associations (813910), Research and Development in the Physical, Engineering, and Life Sciences (54171)
- SIC
- Services-Membership Organizations (8600), Services-Prepackaged Software (7372)
- akta.pro primary industry
- Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF)
- akta.pro secondary industry
- Medical Writing & Regulatory Submission Support CROs (HLAGAAAG)
Keywords
Where clinical research data sharing alliance is headquartered
LocationHeadquarters
- HQ city
- South San Francisco
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
clinical research data sharing alliance business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales, Others
Revenue model
- Membership Dues: CRDSA generates revenue through tiered annual membership dues. For-profit companies pay based on employee count: Tier 1 (2–99 employees) $7,500; Tier 2 (100–999 employees) $15,000; Tier 3 (1,000–9,999 employees) $25,000; Tier 4 (over 10,000 employees) $40,000. New members are prorated for the first year mid-year membership, billed annually on January 1st thereafter. Nonprofit/academic/NGO/health authority members pay no dues but are asked for a minimum non-contractual resource allocation to one or more working groups. Individual contributors pay $250 per year.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Subscription | Annual | Tier 1 For-Profit (2–99 employees) |
| Subscription | Annual | Tier 2 For-Profit (100–999 employees) |
| Subscription | Annual | Tier 3 For-Profit (1,000–9,999 employees) |
| Subscription | Annual | Tier 4 For-Profit (over 10,000 employees) |
| Subscription | Annual | Nonprofit/Academic/NGO/Health Authority |
| Subscription | Annual | Individual Contributor |
Go-to-market motion2 records
Distribution channels3 records
Marketing channels8 records
clinical research data sharing alliance product offering
Product offeringCore offering
CRDSA is a nonprofit consortium that develops and publishes clinical research data sharing standards (CRDSA Std 1001 and Std 2001), assessment frameworks (Data Sharing Assessment App and Data Sharing Technology Assessment Framework), and the Project Concordia agentic AI platform that automates clinical data harmonization across multi-stakeholder trial data. Its offerings are designed for biopharmaceutical companies, academic institutions, data platforms, and health authorities engaged in secondary analysis and regulatory reuse of clinical study data.
Product overview
CRDSA operates as a multi-stakeholder alliance with a unified platform strategy centered on Project Concordia — an agentic AI data harmonization platform — supplemented by published standards (CRDSA Std 1001 and 2001), assessment tools (Data Sharing Assessment App, Data Sharing Technology Assessment Framework), and research publications. The portfolio is designed to address the end-to-end lifecycle of clinical data sharing from preparation standards through secondary analysis and regulatory use, with Project Concordia serving as the flagship AI-powered infrastructure for scalable data harmonization.
Differentiator
Problem solved
Functional benefit
Brands
- Project Concordia: Flagship initiative - an agentic AI platform for clinical data harmonization
- CRDSA Std 1001
- CRDSA Std 2001
Products and services
- Project Concordia A purpose-built agentic AI platform designed to deliver clinical data harmonization as scalable and reproducible infrastructure, transforming months of manual data management into auditable pipelines running in hours. It serves biopharmaceutical sponsors, academic researchers, and clinical data platforms needing to harmonize multi-stakeholder clinical trial data for secondary research use.
- CRDSA Std 1001: Standard for Sharing Clinical Study Data A published standard (v1.0) that promotes data completeness, consistency, interoperability, and information transparency for clinical study data sharing. It is intended for data contributors (sponsors), data sharing platforms, and researchers across the clinical development ecosystem.
- CRDSA Std 2001: Standard for Secondary Analysis of Clinical Study Data A published standard (v1.0) that helps researchers conduct robust analyses and objectively interpret findings from shared patient data, encompassing the end-to-end research process. It is targeted at academic researchers, biostatisticians, and secondary data analysts.
- Data Sharing Assessment App A 15-question scored rubric application that translates the principles in CRDSA's Standard for Sharing Clinical Study Data into a structured instrument to objectively measure completeness and quality of data sharing plans, commitments, or data contributions. It serves data contributors, researchers, and platforms.
- Data Sharing Technology Assessment Framework
Quantifiable outcome
- Transformed months of manual data management into an auditable, reproducible pipeline running in hours through the Concordia platform
- +3 more outcomes
Companies that use clinical research data sharing alliance
Customer profileNamed customers16 records
Segments5 records
Ideal customer profiles5 records
clinical research data sharing alliance technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability3 records
Feature4 records
clinical research data sharing alliance partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- Global Alliance for Genomics and Health (GA4GH)coreCRDSA and GA4GH agreed to a Strategic Partnership beginning June 24, 2025. As organizations sharing passion in developing standards for clinical research data sharing, CRDSA and GA4GH's mutual collaboration is expected to foster greater progress in the data sharing community. CRDSA's CEO Aaron Mann presented at the GA4GH 9th Plenary Meeting (2021), and Bron Kisler participated as presenter/panelist in the 'Building Bridges to Industry and Clinical Care' panel. GA4GH is also listed as a member organization of CRDSA.
Scale indicators4 records
Recent moves6 records
Expansion highlights6 records
clinical research data sharing alliance competitors and assessment
Company assessmentBroad incumbents
- CDISC: Established global standards organization for clinical trial data structure and submission (CDASH, SDTM, ADaM). CDISC is the incumbent in clinical research data standards; CRDSA's Std 1001/2001 are complementary but compete for adoption attention with CDISC's broader, longer-established portfolio.
Direct peers
- Critical Path Institute (C-Path): Non-profit that accelerates medical product development through consortia-driven data sharing and regulatory science collaboration. C-Path's Ramona Walls (Director, Data Collaboration Center) sits on CRDSA's board, and C-Path is a CRDSA member; both develop data standards for clinical research reuse.
- Clinical Trials Transformation Initiative (CTTI): Multi-stakeholder public-private partnership co-founded by FDA and Duke that drives improvements in clinical trial design, conduct, and oversight. CRDSA co-founder Virginia Nido serves on CTTI leadership teams; both organizations serve overlapping biopharma, academic, and regulator stakeholders.
- Vivli: Clinical research data sharing platform that enables sponsors to share individual participant-level data from completed trials. CRDSA's Rebecca Li (Executive Director of Vivli) sits on CRDSA's board, and Vivli is itself a CRDSA member; both target the same biopharma and academic customers seeking to operationalize data sharing and reuse.
- TransCelerate BioPharma: Non-profit industry consortium of biopharma companies driving clinical trial collaboration, including historical trials data sharing initiatives. CRDSA leadership (Aaron Mann, Jules Desmond, Virginia Nido) has direct TransCelerate lineage, and both organizations produce shared data-sharing frameworks for the same biopharma members.
- Forum for Collaborative Research: UC Berkeley-affiliated neutral forum bringing together industry, regulators, patients, and researchers to advance regulatory science. Forum Director Veronica Miller sits on CRDSA's board; both operate as multi-stakeholder convening bodies for clinical research policy and data sharing.
- Global Alliance for Genomics and Health (GA4GH): International standards alliance for genomic and clinical data sharing. GA4GH entered a Strategic Partnership with CRDSA in June 2025; both organizations develop interoperable frameworks for sensitive health data sharing across jurisdictions and stakeholders.
- Project Data Sphere: Independent oncology-focused data sharing platform that hosts patient-level clinical trial data for secondary research. Project Data Sphere's president Jon McDunn sits on CRDSA's board; the organizations are complementary data-sharing infrastructure and standards partners within the same ecosystem.
Regional players
- Health Data Research UK: UK-based national institute coordinating health data research and infrastructure. Founding CRDSA board member Andrew Morris came from HDR UK; the organizations operate comparable multi-stakeholder data-sharing models across different geographies (US-led vs UK-led).
Emerging players
- Yale Open Data Access (YODA) Project: Academic-led clinical data sharing platform that mediates access to participant-level data from industry-sponsored trials. YODA is a more narrowly scoped academic counterpart to CRDSA's broader consortium model, targeting similar secondary-use researchers and sponsors.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
clinical research data sharing alliance social profiles
Digital presenceclinical research data sharing alliance financial estimates
Financial estimateRevenue estimate
Valuation estimate
clinical research data sharing alliance leadership team
Management profileNumber of profiles
Profiles16 records
clinical research data sharing alliance funding detail
Funding detailFunding overview
Funding rounds
Investors
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clinical research data sharing alliance M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about clinical research data sharing alliance
What does clinical research data sharing alliance do?
CRDSA is a nonprofit consortium that develops and publishes clinical research data sharing standards (CRDSA Std 1001 and Std 2001), assessment frameworks (Data Sharing Assessment App and Data Sharing Technology Assessment Framework), and the Project Concordia agentic AI platform that automates clinical data harmonization across multi-stakeholder trial data. Its offerings are designed for biopharmaceutical companies, academic institutions, data platforms, and health authorities engaged in secondary analysis and regulatory reuse of clinical study data.
Is clinical research data sharing alliance a public or private company?
clinical research data sharing alliance is a private company. It is classified as nonprofit foundation owned and is currently operating.
When was clinical research data sharing alliance founded?
clinical research data sharing alliance was founded in 2021. It employs 1 to 10 people.
Where is clinical research data sharing alliance based?
clinical research data sharing alliance is headquartered in South San Francisco, United States, in the North America region.
How does clinical research data sharing alliance make money?
One revenue line is on record: membership Dues.
Who are clinical research data sharing alliance's main competitors?
CDISC is listed as a broad incumbent. Direct peers are Critical Path Institute (C-Path), Clinical Trials Transformation Initiative (CTTI), Vivli, TransCelerate BioPharma, Forum for Collaborative Research, Global Alliance for Genomics and Health (GA4GH) and Project Data Sphere. Health Data Research UK is listed as a regional player. Yale Open Data Access (YODA) Project is listed as an emerging player.
Does clinical research data sharing alliance have an API?
No public API is recorded for clinical research data sharing alliance.
What industry is clinical research data sharing alliance in?
clinical research data sharing alliance's product category is Clinical Research Data Sharing. Its primary akta.pro industry code is HLAGAAAF, Clinical Data Management, Biostatistics & Statistical Programming CROs, with a secondary code of HLAGAAAG, Medical Writing & Regulatory Submission Support CROs. Its NAICS code is 813910 and its SIC code is 8600.