Regulatory Services Engagement with Regulatory Authorities on Patient-Reported Outcomes... Tender

Procurement Summary

Country : USA

Summary : Regulatory Services Engagement with Regulatory Authorities on Patient-Reported Outcomes (Pros)

Deadline : 26 Jan 2024

Other Information

Notice Type : Tender

TOT Ref.No.: 95032844

Document Ref. No. : FY24-CIMC-24-01_Consultant_01

Financier : Other Funding Agencies

Purchaser Ownership : Public

Tender Value : Refer Document

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Tender Details

Request for proposals are invited for Regulatory Services: Engagement with Regulatory Authorities on Patient-Reported Outcomes (Pros)

The Consultant agrees to hold the prices in its offer firm for 60 days from the date
specified for the receipt of offers unless another time is specified in the addendum of the
RFP.

Scope of Work
The FHI 360 project seeks a consultant to lead engagement with regulatory authorities around PRO
measures (PROMs) for CIMCs in contraceptive clinical trials, with an initial focus on FDA avenues
for engagement through the various initiatives on patient involvement during drug development
that are outside of pathways regarding a specific contraceptive product (i.e., a specific drug, device,
biologic, or combination product to prevent pregnancy). Examples of these avenues include the
FDA-s patient-focused drug development initiatives within the Center for Drug Evaluation and
Research (CDER) and Center for Devices and Radiological Health (CDRH), including Critical Path
Innovation Meetings (CPIM), the Clinical Outcome Assessment (COA) Qualification Program, and
the Medical Device Development Tools (MDDT) Qualification Process.
Consultant work will include:
• Providing regulatory advice and guidance to the project.
• Preparing and submitting documents to SRAs with project team oversight.
• Attending and/or leading virtual meetings with SRAs, representing the project with project
team members.
• Developing and updating strategies for regulatory engagement on CIMC PROMs.
Example deliverables/milestones include:
• Provide detailed feedback on a regulatory engagement strategy proposed by FHI 360
• Prepare and submit the request for a CPIM to FDA
• Prepare materials for CPIM and submit to FDA
• Lead CPIM
• Prepare and submit Letter of Intent to COA QP and/or Proposal to MDDT Qualification
Process
• Prepare any updated regulatory engagement strategy to FHI 360, as needed
Intended timeline: Q1-Q3 of 2024
Location of Work: The consultant may work remotely from any location with a reliable internet
connection that permits scheduling meetings during normal business hours in the US Eastern time
zone (UTC-5/UTC-4

Timetable and Address for Submission
Proposals are due no later than 5:00 PM EST (UTC-5) on Friday, January 26, 2024. Required
documentation listed below must be e-mailed to amackenzie@fhi360.org .

Date of Issue of Rfp: Tuesday, 09 January 2024
Date Questions from Supplier Due: Monday, 15 January 2024, 5pm Est
Date Answers Due from Fhi 360: Friday, 19 January 2024
Date Proposal Due: Friday, 26 January 2024, 5pm Est
Approximate Timeframe Consultant
Agreement Issued to Successful Candidate(S): Late February 2024

Documents

 Tender Notice