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Clinical Research Operations and Management System (CROMS) v2.0
National Institute on Aging
The buyer seeks to continue development, maintenance, and operation of a unified Clinical Research Operations & Management System (CROMS). The system will support NIA's extramural research program, managing a large clinical trial portfolio. The buyer requires services including system development, deployment, maintenance, analytics, and user support. The project involves migrating to NIH Cloud and implementing AI technologies to enhance data processing and decision-making capabilities.
- 10/15/2024 - Proposal Due Date
- 10/28/2024 - Industry Day
- Experience in developing clinical research IT systems for NIH or similar organizations
- Knowledge of clinical research, NIA scientific agenda, and AD/ADRD research domains
- Expertise in cloud-based IT environments and NIH cloud migration
- Experience supporting organizations conducting clinical trials and managing operational processes
- Expertise in managing Data and Safety Monitoring Boards (DSMBs)
- Maintain and enhance existing NIA CROMS components
- Develop new CROMS components and features
- Migrate NIA CROMS to NIH Cloud (STRIDES)
- Provide helpdesk and user support services
- Develop and maintain business models for clinical research processes
- Ensure system compliance with FDA and ICH requirements
- Develop NIA-wide reporting and analytics capabilities
- Implement AI and Gen AI technologies within CROMS
- Provide data management and quality control support
- Conduct computer system validation activities
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