SAM #75N98026R00034

NHGRI IDIQ for Clinical Research Support and Proteus Syndrome Protocol Services

The National Institutes of Health is seeking a small-business contractor to provide clinical research support for National Human Genome Research Institute protocols through a three-year IDIQ. - Government buyer - Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Human Genome Research Institute (NHGRI). - Acquisition office: NIH Office of Acquisitions and Logistics Management (OALM), R&D Branch B. Work also involves NHGRI’s Office of the Clinical Director (OCD) and, for an evaluation task order, the Social and Behavioral Research Branch (SBRB). - Requested services - Clinical research and trial management, protocol monitoring and development, data management, site management, statistical design and analysis, and bioinformatics or other analytical support. - Regulatory affairs, including IND/IDE support; pharmacovigilance and medical monitoring; quality assurance; and Data and Safety Monitoring Board (DSMB) administration and reporting. - Task Order 1 supports the continued-treatment period for Proteus syndrome protocol 20-HG-0034, a Phase 2 study of MK-7075 (miransertib). Work includes monitoring, database and case-report-form support, IND and FDA meeting support, medical monitoring, and statistical/DSMB reporting. - Evaluation-only task orders describe OCD support for protocol monitoring and quality assurance, data management, IND/IDE regulatory support, DSMB operations, statistical expertise, and task-order coordination; and SBRB statistical support. These evaluation task orders are not awarded with the parent contract. - Requirements and considerations - Staff should have relevant clinical trial, regulatory, statistical, and data-management expertise, particularly in rare and genetic diseases, human genetics and genomics, gene and cell-based therapies, and pediatric and adult research. - The contractor may handle sensitive participant-level clinical, genetic/genomic, laboratory, and safety information. Security and privacy requirements apply to a Moderate-impact system involving PII, including incident reporting, personnel screening and training, and data protection. - Quarterly and final technical reports are required; reports must be electronic and Section 508 compliant. Database support may use CTDB, REDCap, or another Government-designated system. - Work is primarily performed at the contractor’s site, with some travel to NHGRI at the NIH campus in Bethesda, Maryland. Task orders may be time-and-materials or firm-fixed-price. - OEMs and vendors - No manufacturers, OEMs, or contractor vendors are identified. MK-7075 (miransertib) is named as the study drug, not as a product being purchased. CTDB and REDCap are named as possible data-management systems. - Contract scope and value - The IDIQ has a three-year ordering period and a possible extension of up to six months. Its stated minimum value is $50,000 and maximum value is $4,000,000. - No equipment or other product purchases, product part numbers, or product quantities are specified.

Description

The goal of this acquisition is to acquire a contractor that offers a full range of (1) clinical research services, including clinical research management, statistical design and analysis, protocol development and data management, clinical site management, pharmacovigilance services, quality assurance, and regulatory affairs support; (2) specialty services, including DSMB services; (3) analytical solutions, including bioinformatics, and (4) integrated clinical trial management through an organized system of tracking clinical trials. The contractor should be capable of providing these services, as required under the individual task orders, to support NHGRI clinical research protocols and related activities within the scope of this IDIQ contract. The contractor should be capable assigning qualified personnel with experience in clinical trial design and regulatory requirements, especially as relates to studies of rare diseases, genetic conditions, gene therapy (including via AAV9 vectors), and pediatric as well as adult populations, as applicable to individual task orders.

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