EOI:: IMPLEMENTING THE PRESIDENTS DEPARTMENT OF GOVERNMENT EFFICIENCY COST EFFICIENCY INITIATIVE (MARCH 19, 2025)::EOINOTICE OF TERMINATION FOR CONVENIENCEBESPOKE GENE THERAPY CONSORTIUM COORDINATIO

Iqvia Government Solutions Inc., Falls Church VA

Investigators

Abstract

Bespoke Gene Therapy Consortium Coordination Center (BGTC CC) Electronic Data Capture (EDC) Platform Support This action is to obtain cloud-based electronic data capture (EDC) software and provide services to provision it in accordance with NCATS data environment standards to support clinical data management and analysis requirements of the Bespoke Gene Therapy Consortium (BGTC). The BGTC is part of the Accelerating Medicines Partnership (AMP) program, a public–private partnership among NIH institutes and centers (IC), the U.S. Food and Drug Administration (FDA), multiple pharmaceutical and life sciences companies, and nonprofit and other organizations. The AMP program, which is managed by the Foundation for the NIH (FNIH), aims to improve current models for developing diagnostics and therapies. NCATS is the lead NIH IC for BGTC, one of several NCATS-led programs aligned with the NCATS’ mission to re-engineer the translational research process so new treatments and cures for diseases can be delivered to patients faster. The BGTC is establishing platforms and standards to speed the development and delivery of customized or “bespoke” gene therapies (GT) that could treat millions of people affected by rare diseases, including diseases too rare to be of commercial interest. BGTC program management is performed through the BGTC Coordination Center (BGTC CC). The BGTC CC coordinates consortium development of early-stage gene therapy drug candidates (currently 7 candidates) to treat selected rare diseases. Gene therapy development includes early-stage drug development, pre-clinical evaluation, regulatory preparation, and program platform operations in advance of initiating clinical trials. To meet the data management requirements for this gene therapy effort, the BGTC CC is developing a centralized regulatory and Quality Management System (QMS)-compliant Electronic Data Capture (EDC) and electronic Clinical Outcome Assessment (eCOA) platform that will be used by all participants in this drug development effort. The BGTC has standardized on Metadata Rave, a commercial, widely used cloud-based EDC software as a service (SaaS), as the platform for secure clinical trial data services. To meet the requirements for privacy, security, and long-term sustainability of all data collected in support of the BGTC, the Government will contract for the cloud platform services that support BGTC data collection, dissemination, analysis, integration, reporting, and management. Rare Diseases