CDISC Membership
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $10,000 to $25,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 541990 All Other Professional, Scientific, and Technical Services
- Points of contact
-
- tbd@fda.gov
- Christopher Scott christopher.scott@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration (FDA) is seeking to renew its annual membership with CDISC (Clinical Data Interchange Standards Consortium), a critical standard-setting organization for clinical and non-clinical data reviews. The procurement aims to maintain the FDA's leadership in global regulatory health data standards, with an estimated solicitation release date of July 1, 2026, and an anticipated award date of September 1, 2026. The contract falls under the NAICS code 541990 for Professional, Scientific, and Technical Services.
The annual membership is estimated to cost between $16,000 and $18,000 and is considered a strategic investment to support the FDA's regulatory review modernization efforts. The primary point of contact for this opportunity is Christopher Scott, who can be reached at christopher.scott@fda.hhs.gov within the Food and Drug Administration. While specific performance location details are not provided, the contract will support the FDA's ongoing participation in developing and maintaining critical data standards for clinical and non-clinical reviews.
Forecast text
The CDISC standard serves as the foundational data standard for FDA's daily operations in conducting clinical and non-clinical reviews. Our continued participation in CDISC discussions and standard development ensures that FDA maintains its position as the leading global regulatory health authority in establishing critical data standards. Without proper data standards like CDISC, FDA cannot effectively modernize the regulatory review process. The annual membership renewal cost ($16K-$18K per year) represents a minimal investment that enables FDA to exercise leadership in the global regulatory review arena.
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