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 It compares the scope and intent of each agency’s draft guidance, highlighting MHRA’s broader inclusion of hybrid and augmented trial designs as a more flexible, patient-centered model.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…)

PISCATAWAY, NJ, July 23, 2024 — The Clinical Research Data Sharing Alliance (CRDSA) is pleased to announce the appointment of two new board members: Stephen Pyke of Parexel and Veronica Miller of the Forum for Collaborative Research. (more…)