Tuesday, November 26, 2024

NIH RFI: NIEHS Clinical Trials Management Software (CTMS)

Notice ID: 75N96023Q00005

Description

The NIEHS Clinical Research Unit (CRU) utilizes Clinical Conductor software as a system to maintain and manage many clinical research operational processes, including planning, managing and tracking 50-75 studies from beginning to end, regulatory management, visit workflows, participant status of 7500 unique individuals, study milestones, and financial reporting. The Clinical Conductor software is installed on an on-premises server within the NIEHS data center. Advarra, the manufacturer of Clinical Conductor software is changing their support model to discontinue support for on-premises installations in favor of a hosted solution. The NIEHS cannot take advantage of the economies of a cloud hosted solution unless that solution is FEDRamp authorized, ready, or in process.

The NIEHS CRU seeks information on commercial CTMS solutions to provide automation of workflow for entire study operations including but not limited to the following:

General

  • The system must allow on-premises hosting or be FEDRamp authorized, ready, or in process.
  • Professional services for migration of data from Advarra Clinical Conductor to a new system.
  • Professional services for training clinical staff in the use of the system.

Read more here.

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