Request for Proposal (RFP) for a CRO

Request for Proposals (RFP)

TB Alliance Background

TB Alliance is a product development partnership (PDP), working to discover and develop better, faster acting, and affordable drugs to fight tuberculosis. We envision a world where no one dies of tuberculosis. However, this cannot be achieved without new, better, and faster-acting tuberculosis drug regimens. The Global Alliance for TB Drug Development (TB Alliance) was established in 2000 as a not-for-profit product development partnership to lead the search for new TB regimens and catalyze global efforts for new TB regimens that can bring hope, and health, to millions.


Request for Proposal Objective

This Request for Proposal has been prepared to facilitate collecting bids from a qualified contract research organization (CRO) with staff appropriate for supporting regulatory activities and specifically IND maintenance.

Bid Requirements

The bid should include the following components:

    1. A capabilities statement, including (a) relevant institutional experience, (b) the specific personnel who will complete the described work and their relationship to the bidder (i.e., employee of bidder or subcontractor), and (c) curriculum vitae of key personnel who will complete the work (e.g., principal investigator, study coordinator, statistician, etc.).
    2. A detailed budget should include the following:
      1. Relevant assumptions
      2. Definition of the scope of work
      3. Time for routine meetings with TB Alliance for each activity
      4. Timeline for deliverable(s)
      5. Fixed costs and projected Pass Through for completing work.
    3. Request for information should be submitted to:

      David.Kim-consultant@www.tballiance.org

Timeline for RFP

The deadline to submit a proposal is November 30, 2022. Please contact TB Alliance for more information.


Regulatory Support Specifications

Scope

A total of 6 open INDs are planned to be transferred to the prospective service provider.

The immediate need is the submission of approximately 7 clinical documents, 6 DSUR/Annual Updates, and an estimated total of 28 site documentation planned for submission in 2023. The volume will need to be updated annually.

Services (Please provide a budget for each category)

A total of 6 open INDs are planned to be transferred to the prospective service provider.

  1. IND Maintenance
    • IND Safety Reports (SUSARs, Aggregate Safety Reports, Other Safety Reports including non-clinical findings)
    • DSUR/Annual Report Submissions
    • Ongoing Clinical Trial Documents/Forms (Protocols, CSRs, 1571/1572, Financial Disclosures etc.)
    • Cross references to other INDs (for combination clinical trials
    • FDA Interactions (meetings, communication on behalf of TB Alliance)
  2. Writing and Publishing
    • DSUR/Annual Report
    • Investigator’s Brochures
    • Briefing Books
    • FDA Meeting Package
    • Manuscripts (publications)
  3. Electronic Document Submissions in compliance with eCTD
  4. Document Management & Storage in compliance with CFR21-Part11
  5. Clinicaltrials.gov Updates
  6. Statistics
    • Transfer of anonymized SDTM trial datasets to collaborators