Bespoke Gene Therapy Consortium Coordination Center (BGTC CC) Electronic Data Capture (EDC) Platform Support   2

Background
The Bespoke Gene Therapy Consortium (BGTC) is part of the Accelerating Medicines Partnership (AMP) program, a public-private partnership involving NIH, FDA, pharmaceutical companies, and nonprofit organizations. The AMP program aims to enhance models for developing diagnostics and therapies.

Managed by the Foundation for the NIH (FNIH), the BGTC focuses on re-engineering the translational research process to expedite the delivery of new treatments for rare diseases. The BGTC is establishing platforms and standards for developing customized gene therapies that can benefit millions affected by rare diseases.

Work Details
The acquisition seeks cloud platform services to support data collection, dissemination, analysis, integration, reporting, and management of the BGTC. Specifically, it involves obtaining cloud-based electronic data capture (EDC) software and related services to meet clinical data management requirements.

The EDC/eCOA system will be developed under a task order from the NIH-wide Project, Program, and Portfolio (P3) Support Services Contract. This contract was awarded to Black Canyon Consulting, LLC as a single award contractor. The EDC system will utilize Medidata Rave as the standard commercial EDC across all gene therapy trials sponsored by BGTC.

Period of Performance
The period of performance for the task order is from 09/01/2023 through 08/31/2026.

Place of Performance
The services will be performed at the National Center for Advancing Translational Sciences (NCATS) located in Rockville, MD.