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REQUIREMENT The scope of activities FDA may require of the contractor shall include the capability to conduct multiple Phase I clinical trials within a year and at times in parallel, and the provision of a full range of services to support the clinical trials and reporting of the results. All clinical trials shall be carried out in a timely fashion and in compliance with all FDA regulations and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines. The contractor should also be able to provide laboratory studies including bioanalytical/biomarker/omics support that includes determination of drug concentration, anti-drug antibodies, and multiple pharmacodynamic biomarkers. Any bioanalytical/biomarker work shall be carried out in a timely fashion. Unless otherwise specified, method validation shall be performed in compliance with FDA’s Bioanalytical Method Validation Guidance (https://www.fda.gov/media/70858/download). Sample analysis does not need to be performed under complete Good Laboratory Practice (GLP) guidelines. The Contractor shall ensure adequate contracting support is provided to the FDA. This Statement of Work (SOW) has been divided into 2 Performance Areas: A) Overall Clinical Operations Support and Clinical Trial Execution in Healthy Subjects or Patients and B) Bioanalytical/Biomarker/’Omics’ Analysis and Laboratory Support. To qualify for award, organizations must have in-house capabilities in Performance Area A, which will represent the majority of the work. Organizations may either have in-house or sub- contracting capability for Performance Area B. See the Section C Statement of Work (SOW) for the full requirement. 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