FDA CDER Sources Sought: Risk Evaluation and Mitigation Strategy (REMS) Integration Pilot

Notice ID: FDA-75F40124S00181

The purpose of this contract is to (1) provide technical support for a real-world REMS integration pilot, and update the REMS Integration FHIR Implementation Guide (IG), that can advance the REMS integration standard based on real-world learnings; and (2) demonstrate through a technical pilot, automation of routing of REMS through the REMS ecosystem, including when there is more than one REMS administrator for a given REMS drug.

The primary objectives of this contract are to provide technical support services, taking an agile approach, in support of the FDA/CDER REMS integration pilot which include:

1. Continue to support the REMS integration real-world pilot, providing technical support to sites that are implementing the prototype. This also will require working with the CodeX REMS Integration Use Case community of stakeholders.
2. Update the FHIR implementation guide for REMS integration to make sure that learnings from the pilots are incorporated and can be used by future implementers and to enable a feasible and scalable solution.
3. Develop the technical approach utilizing cotemporary health data standards (e.g., HL7 FHIR and NCPDP) that interfaces with EHR systems and pharmacy information systems (PIMS) to provide appropriate REMS routing of REMS requirements and corresponding data to the correct REMS administrator based upon the unique drug product at the National Drug Code (NDC) level to be dispensed or administered to the patient.
4. Conduct a REMS routing pilot to demonstrate that the REMS integration solution can be employed for REMS drugs that require routing to different REMS administrators.

Task 1: Study Implementation and Execution

The Contractor shall provide technical support for the execution of the real-world REMS integration pilot(s) as part of the CodeX REMS Integration pilot team.

Activities may include:

• Provide technical site support during implementation based on experience with standards-based implementation
• Work with the HL7 CodeX REMS Integration Use Case Community and establish participating clinical sites for their technical staff to configure their respective information technology systems and implement the REMS integration prototype at their sites
• Provide regular updates on CodeX use case calls, with solicitation of input throughout the process based on issues that arise
• Address bug reports from stakeholders as applicable
• Maintain and update accessible REMS integration prototype webpage on cloud-based server
• List of issues and learnings identified throughout implementation
• Updates to implementation guide as needed based on pilot findings, working with the HL7 CodeX REMS Integration Use Case Community
• Updates to prototype as needed based on pilot findings
• Complete evaluation and report
• Document considerations for sites and other organizations who want to implement this or a similar approach in the future
• Support the HL7 balloting process and finalization of an updated REMS integration FHIR IG based on the pilot experience
• Support publication of results in a peer-reviewed journal
• Final report and presentation, including evaluation and next steps for commercialization / transition …

The period of performance (PoP) shall be twelve (12) months from the date of award.

Read more here.

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