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Clinical Trial Management and Coordination

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Contract Overview

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

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This subcontract for Clinical Trial Management and Coordination supports the Department of Defense TBIPHRP projects by providing day-to-day management of clinical trials for prime contractors. The scope of work includes managing data and clinical coordinating centers, standardizing procedures across various research sites, and overseeing the secure transfer of data, specimens, and imaging products. These operations are executed using Clinical Trial Management Systems and strict secure data transfer protocols to ensure operational efficiency. The project requires strict adherence to FDA regulatory compliance, Good Clinical Practice guidelines, and IRB approvals. The primary deliverables consist of completed clinical trial data sets and all necessary regulatory filings. This effort is categorized under NAICS code 541710 and is managed through the Department of the Army USAMRRA.

General Info

Subcontract for DoD TBIPHRP clinical trial management, coordination, and FDA regulatory compliance.

Agency

Department Of Defense → Department Of The Army -- UsamraaView Agency

NAICS

541710 - Research and Development in the Physical, Engineering, and Life SciencesView NAICS

Place of Performance

Not specified

Set-Aside

NONE

Documents

This scope was carved out of HT942526TBIPHRP.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

DoW Traumatic Brain Injury and Psychological Health, Clinical Trial Award

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Timeline

PostedMay 6

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Organization & Contact Information

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AgencyDepartment Of Defense → Department Of The Army -- Usamraa

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Defense → Department Of The Army -- Usamraa

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Office AddressN/A

ContactsNo contact information available

Full Description

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Performs day-to-day management of clinical trials for prime contractors on Department of Defense TBIPHRP projects. Manages data and clinical coordinating centers, standardizes procedures across research sites, and handles data transfer and specimen/imaging product sharing. Utilizes Clinical Trial Management Systems (CTMS) and secure data transfer protocols. Requires GCP and IRB approvals and FDA regulatory compliance. Delivers completed clinical trial data sets and regulatory filings.

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