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Office of Biostatistics Cytel Software

Active

Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

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The Office of Biostatistics requires Cytel software to support critical review functions involving power and sample size calculations, adaptive clinical trial designs using EAST, and exact statistical analyses via StatXact. The contract is driven by the need for specialized statistical tools that enable accurate and compliant regulatory evaluations, particularly those requiring precise methodologies not fully supported by standard software. Increased costs are attributed to upgrades and additional licensing for StatXact procedures linked to SARGE in SAS environments, reflecting expanded usage and enhanced computational demands. The procurement is forecasted by the Food and Drug Administration under NAICS code 519130, with no set-aside designation, and will be managed through the Center for Drug Evaluation and Research acquisitions office, with inquiries directed to the Cder Acquisition Liaison. The contracting officer position remains to be determined at this stage.

General Info

Procurement of Cytel software for FDA biostatistics to enhance statistical review and trial design.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

519130 - Internet Publishing and Broadcasting and Web Search PortalsView NAICS

Place of Performance

US

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

PostedMay 25

forecast

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Organization & Contact Information

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AgencyFood and Drug Administration → Food And Drug Administration

Contacts2 people available

OfficeN/A

Organization / Agency

Food and Drug Administration → Food And Drug Administration

Office AddressN/A

Contacts

Cder Acquisition Liaison

contact@example.gov

To Be Determined To Be DeterminedContracting Officer

Full Description

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Office of Biostatistics Cytel Software Required for review work, specifically power and sample size calculations, adaptive designs (EAST), exact statistical calculations (StatXact). Increased cost driven in part by additional cost due to increase in costs of StatXact Procs with SARGE (SAS).

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