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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

Closed
Federal

Contract Overview

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

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NAICS: 541611
New
SLED
Pinellas County SBE Consultants per the Consultant Competitive Negotiations Act (CCNA)
Solicitation # 26-0853-RFQ-CCNA
Pinellas County's Office of Management and Budget is seeking to establish a pool of certified Small Business Enterprise (SBE) consultants under the Consultant Competitive Negotiations Act (CCNA). This ongoing solicitation aims to increase the utilization of SBEs for professional services including engineering, architectural, landscape architecture, planning, coastal management, construction management, and survey and mapping. The program specifically targets work assignments that do not exceed the 150,000 dollar local market threshold. To be eligible, firms must be located in Pinellas, Hillsborough, Pasco, or Manatee counties, employ no more than 50 full-time staff, and meet annual gross revenue limits of 3 million dollars for selective goods and services or 8 million dollars for construction providers. Applicants are evaluated based on the ability of professional personnel, experience and past performance, and SBE status, requiring a minimum score of 75 points to be accepted onto the shortlist. Required submission documents include an introduction letter, a completed SF-330, a Pinellas County SBE certificate, professional Florida licenses, and a signed insurance statement. All engineering and survey deliverables must adhere to the latest Pinellas County CADD Standards Manual and Kit. Insurance requirements include 1 million dollars for professional liability and commercial general liability per occurrence, with specific mandates for tail coverage and naming Pinellas County as an additional insured.
OMB - PURCHASING

POSTED

1 day ago

DEADLINE

in almost 5 years

AI 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

Providing FDA, HIPAA, and ICH-GCP compliance consulting for secure Vitrium clinical trial data deployment.

Agency

Department Of Health And Human Services → National Institutes Of Health OlaoView Agency

NAICS

541611 - Administrative Management and General Management Consulting ServicesView NAICS

Place of Performance

Rockville, MD, 20852, USA

Set-Aside

NONE

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.

View the prime solicitation

VITRIUM SECURITY ENTERPRISE LICENSE

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Timeline

PhaseClosed
Posted

subcontract

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health Olao
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Health And Human Services → National Institutes Of Health Olao
View Agency Profile
Office AddressN/A
ContactsNo contact information available

Full Description

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Provide advisory services to ensure the Vitrium platform’s deployment meets FDA, HIPAA, and ICH-GCP requirements for handling clinical trial data.

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