Medidata Solutions, Inc.

Medidata Solutions, Inc. is a foreign-owned, for-profit cloud-based software and data analytics company headquartered in New York that has been registered in SAM.gov since November 2007. The company specializes in electronic data capture, clinical trial management, and remote monitoring software solutions that support biomedical research and clinical studies across federal agencies. Medidata serves as a critical technology provider to the National Institutes of Health and its subsidiary institutes, delivering validated, federally and internationally compliant platforms that enable clinical sites to conduct remote monitoring activities and manage large portfolios of clinical trials.

Medidata Solutions has secured substantial federal contract awards totaling approximately $61.8 million through prime contract vehicles awarded by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Cancer Institute (NCI), all structured as firm fixed-price purchase orders and delivery orders with no small business set-aside designations. The company's primary offering through these awards has been its Remote Source Review (RSR) software-as-a-service platform, which enables electronic monitoring of clinical studies and site compliance verification. NIAID has been the primary customer for RSR renewals, with multiple purchase orders spanning from March 2021 through June 2026, ranging from approximately $91,820 to $2.67 million annually, supporting the Division of AIDS' clinical trial monitoring activities. Additionally, Medidata holds delivery orders under an indefinite delivery contract with the National Cancer Institute for hosting, maintenance, and professional services supporting the Medidata Rave electronic data capture system, with a $50.06 million delivery order awarded in September 2023 extending through August 2028 to support approximately 500 Cancer Therapy Evaluation Program studies. The company's contract work includes subscription services for study lanes, professional services for new study builds, post go-live support, and system maintenance, all performed on a sole-source basis under Federal Acquisition Regulation 13.106-1(b)(2), as NIAID determined Medidata was the only responsible source capable of delivering the validated platforms required for federal clinical studies. Medidata also serves as a subcontractor, having provided services under prime contracts awarded to Takeda Vaccines Inc. (November 2022) and Deloitte & Touche LLP (June 2023).

Medidata Solutions holds a single-award indefinite delivery contract with the National Cancer Institute valued at $74 million over five years, awarded September 1, 2023, with an ultimate completion date of August 31, 2028. This contract encompasses hosting, maintenance, and professional services for the Medidata Rave electronic data capture system and integrated ancillary software products including Targeted Source Data Verification, Electronic Patient Reported Outcomes, and Balance randomization software. The indefinite delivery contract structure allows the National Cancer Institute to issue task orders as needed to support its evolving clinical trials portfolio, with services including system hosting, maintenance support, training, consulting, and ancillary software licensing. Under this IDV framework, the National Cancer Institute has already awarded a $604.23 million firm fixed-price task order for professional services related to Rave's instance supporting the Center for Biomedical Informatics and Information Technology (CBIIT), with performance extending through August 31, 2029. The contract was specifically designed to provide clinical trials infrastructure support through the incumbent contractor's established electronic data capture platform to manage the National Cancer Institute's extensive research portfolio, demonstrating the federal government's reliance on Medidata's validated platform for mission-critical clinical research operations.