ADAPT Contract Research Organization - Sources Sought

Background
The Advanced Research Projects Agency for Health (ARPA-H) Resilient Systems Office (RSO) is seeking to procure Contract Research Organization (CRO) services for the ADvanced Analysis for Precision cancer Therapy (ADAPT) program. The mission of ARPA-H is to accelerate better health outcomes by supporting the development of high-impact solutions to society’s most challenging health problems.

The ADAPT program aims to revolutionize cancer treatment by developing adaptive strategies that target the evolution of cancer, specifically focusing on metastatic breast, lung, and colon cancers. The program will utilize linked evolutionary clinical trials to adjust drug treatments based on tumor evolution during multiple sequences of therapy.

Work Details
The Contractor will provide Clinical Trial Management, Oversight, Operations, and Research support services. Key tasks include:

1. Assessment and Assistance for Clinical Site Preparation, Initiation, and Activation; Study Documents and Reports:
- Serve as a technical expert for ARPA-H supported clinical study investigators ensuring compliance with applicable policies and standards.
- Provide support during study preparation, initiation, and site activation as requested by ARPA-H.
- Track all study documentation in an electronic Clinical Trial Management System (CTMS).
- Assist in writing, reviewing, and tracking study protocols and documents for quality and compliance with Good Clinical Practice (GCP).
- Develop protocols and complete forms for various committees such as IRBs and FDA.

2. Establish coordination among multiple ADAPT performers across different geographical locations for real-time clinical interventions and tumor biology assessments.

Place of Performance
The contract will be performed across multiple geographical locations where clinical trials are conducted.