ADAPT Contract Research Organization - Sources Sought

Closed Pre-Solicitation Posted

Solicitation number
75N992-24-RFI-103
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Bethesda, Maryland, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The Advanced Research Projects Agency for Health (ARPA-H) Resilient Systems Office is seeking to procure Contract Research Organization (CRO) services to support the ADvanced Analysis for Precision cancer Therapy (ADAPT) program. The ADAPT program aims to revolutionize cancer treatment by developing new adaptive strategies that target the evolution of cancer. The CRO will provide clinical trial management, oversight, operations, and research support services to accomplish the program's objectives, which include developing biomarkers of treatment response and a clinical trial infrastructure that supports adaptive therapies. ARPA-H is seeking feedback on the draft Performance Work Statement, which outlines the key tasks required, including study operations and review, biological testing of patient samples, centralized clinical and research data management, regulatory submission support, and general logistical and administrative support.

This opportunity is not set-aside and does not have any incumbent contractors identified. The estimated effort is for a 5-year period with 1,700 patients enrolled, each with multiple tissue and liquid biopsies. ARPA-H is looking for responses to the Request for Information by September 26, 2024, which will be used for market research purposes only and will not result in a reimbursement for response costs.

Notice text

The Advanced Research Projects Agency for Health (ARPA-H) Resilient Systems Office seeks to support the procurement of Contract Research Organization (CRO) services for the ADvanced Analysis for Precision cancer Therapy (ADAPT) program. The ADAPT Program aims to revolutionize cancer treatment by developing new adaptive strategies targeting the evolution of cancer. The program will examine a tumor’s behavior as it changes and will then match each patient’s evolving cancer with the best available therapy. ADAPT will revolutionize cancer care by bringing new science and medicine together to map and target tumor changes that improve survival for patients with metastatic cancer. Key objectives include development of biomarkers of treatment response that can inform and improve patient care decisions, and a clinical trial infrastructure that supports adaptation of therapies iteratively using biomarkers.  

The ADAPT Program will include linked evolutionary clinical trials undertaken in breast, colon, and lung cancers.

The Contractor will provide Clinical Trial Management, Oversight, Operations, and Research support services to accomplish the mission.  The Contractor will provide ARPA-H and its performers with management and research support services, including, but not limited to, systems and tools to assist in the effective oversight and administration of its clinical research program. In addition, the Contractor will provide adjunct expertise and resources to assure rigorous and efficient clinical study documentation, clinical site monitoring, data and safety monitoring, data management support, and regulatory compliance.

This RFI serves to request feedback on the draft tasks within the PWS. Specifically, ARPA-H is looking for feedback, questions, or areas of clarification on tasks within the PWS.

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