This Government Contract opportunity from Department Of Health And Human Services was posted on May 13, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.
Regulatory Compliance Consulting for Clinical Trial Artifacts
Contract Overview
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The contract seeks advisory services to ensure the Vitrium platform’s deployment aligns with FDA, HIPAA, and ICH-GCP regulatory standards for the handling of clinical trial data. The work involves guiding implementation to meet stringent requirements around data integrity, privacy, and compliance in clinical research environments, with a focus on securing sensitive trial artifacts throughout their lifecycle. The services are intended to support compliance readiness and operational adherence in a highly regulated healthcare and research context. This is a subcontract under the National Institutes of Health, part of the Department of Health and Human Services, with performance located in Rockville, Maryland, 20852. The solicitation was posted on May 13, 2026, and responses are due by May 23, 2026. The NAICS code 541611 identifies the work as management consulting services, indicating a focus on strategic regulatory guidance rather than technical development or system implementation. The contract does not specify a set-aside designation and provides no point of contact information, suggesting the opportunity is open to qualified vendors with demonstrated expertise in pharmaceutical and clinical trial regulatory compliance.
General Info
Agency
NAICS
Place of Performance
Rockville, MD, 20852, USASet-Aside
Documents
This scope was carved out of NIH-NOI-26-2280816.
The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.
VITRIUM SECURITY ENTERPRISE LICENSE
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Timeline
Submission Closed
Organization & Contact Information
Full Description
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