South San Francisco, CA, Monday November 2, 2026 – Thanks to five years of commitment from our members and contributors, the Clinical Research Data Sharing Alliance (CRDSA) has achieved what it was founded to do and will cease to operate from the end of this year. What we built together stays open: for a minimum of three years from January 1, 2027, all resources created by CRDSA will continue to be freely available via our existing website.

CRDSA was established as a multi-stakeholder nonprofit alliance in 2021 as a neutral forum for organizations to collectively address the logistical, cultural, and policy challenges faced by both data contributors and research users. Since our founding, major accomplishments include the development and publication of over 20 resources, among them standards for sharing clinical study data and for secondary research use; best practices for data reuse in regulatory submissions; external controls policy advancement; and tools for evaluating data sharing plans and data contributions. Reflecting the value of this work, our membership during this period has grown to include biopharma companies, academic institutions, and nonprofit organizations engaged in clinical data sharing. Most recently, CRDSA’s work advanced the development of an AI-powered data transformation platform, capable of massively speeding up the process of standardizing disparate clinical study datasets.

CRDSA’s Board recognizes that the strongest demand for data harmonization has come from commercial organizations, and that operationalizing a commercial data product is beyond CRDSA’s organizational scope and nonprofit remit. A new commercial entity, A2Knowledge (A2K), has been formed and is better placed to lead this next phase of activity. A2K has been established under the leadership of CRDSA’s CEO and co-founder, Aaron Mann. We wish Aaron, and A2K, every success as he builds out this new business, and we are confident it will bring new value to the community CRDSA has served these past five years.

The Board is pleased to confirm a commitment by A2K to support academic and nonprofit organizations with preferential pricing over a core suite of clinical trial dataset transformation and harmonization offerings. Please contact A2K directly for details (see below).

Between now and the end of this year, Aaron, in concert with the Board, will work to ensure a managed wind-down of activities, including wrapping up the work of the various work groups and committees in place. We will not be accepting membership renewals or new applications for 2027 onward.

We take this opportunity to thank all those who have supported our endeavors over the past five years: our members, those who contributed their time and expertise to create the resources we have been able to publish; those who participated, whether as speaker, moderator or attendee, in the events we have staged; and all those who have provided valuable feedback to us as they have sought to make use of these resources.

If you have any questions relating to the closure of CRDSA, or about the resources we have published, please contact us at admin@CRDSAlliance.org.

To learn more about A2K and the academic/nonprofit research offering building on the work we have begun, please visit https://a2knowledge.com/research-program/ or contact Aaron Mann at aaron.mann@a2knowledge.com.

South San Francisco, CA, October 20, 2025 — The Clinical Research Data Sharing Alliance (CRDSA) is pleased to announce the publication of “External Controls – Evolving Regulatory Approaches”.

This October 2025 CRDSA white paper, External Controls—Evolving Regulatory Approaches, analyzes how MHRA, EMA, and FDA are approaching the regulatory use of externally controlled clinical trials. It compares the scope and intent of each agency’s draft guidance, highlighting MHRA’s broader inclusion of hybrid and augmented trial designs as a more flexible, patient-centered model. The paper also outlines implications for sponsors and regulators seeking globally harmonized standards, consistent evaluation frameworks, and reproducible methodologies.

CRDSA is delighted to announce the beginning of a Strategic Partnership with Global Alliance for Genomics and Health. As organizations that share passion in developing standards for clinical research data sharing, CRDSA and GA4GH’s mutual collaboration will be able to foster even greater progress in the data sharing community.

Read more in the official press release: https://www.ga4gh.org/news_item/ga4gh-and-crdsa-agree-to-a-strategic-partnership/

The Evidence Base, a news hub covering topics including real-world data and outcomes research, discusses the CRDSA’s recent October 22nd publication in “CRDSA releases report on data platforms supporting real-world data in regulatory submissions” emphasizing the significance of the paper and it’s role in providing recommendations for data platforms to better serve the clinical world.

South San Francisco, CA, October 22, 2024 — The Clinical Research Data Sharing Alliance (CRDSA) is pleased to announce the publication of “Data Reuse in Regulatory Submissions: The Role of Data Platforms.”

This paper examines the benefits and challenges of using supplemental and external controls in regulatory submissions. Data platforms are an integral part of the ecosystem, enabling trial sponsors to access and use patient data from real-world settings and prior clinical trials. The paper recommends specific steps data platforms can take to support sponsors in meeting health authority expectations. (more…)

PISCATAWAY, NJ, September 26, 2024 — The Clinical Research Data Sharing Alliance (CRDSA) is pleased to announce the publication of two new standards: the Standard for Sharing Clinical Study Data and the Standard for Secondary Analysis of Clinical Study Data. (more…)