Clinical Trial Coordination for BLAAC-PD – Request for Proposals (RFP)

Background

The Global Parkinson’s Genetics Program (GP2) and its implementation partner The Michael J. Fox Foundation (MJFF) are seeking a qualified organization to manage and support the Black and African American Connections to Parkinson’s Disease (BLAAC PD) study operations and data management. If your organization also offers database management and Electronic Data Capture services, please submit a combined proposal. Organizations that can provide both clinical trial coordination and data management are preferred. More information can be found on the BLAAC PD Data Management RFP. 

Research on the genetics of PD have largely been conducted with people of European descent. The lack of diversity in this research has negative implications on the generalizability of research discoveries and worsens the existing racial disparities in healthcare. Black and African Americans continue to be underrepresented in PD research. BLAAC PD was launched in 2021 by the Global Parkinson’s Genetics Program and is focused on engaging Black and African Americans with and without Parkinson’s disease (PD). The study’s goal is to create a cohort of Black and African American individuals to help genetic researchers understand what PD looks like for Black and African American communities and contribute to a more complete, global picture of the condition. Data analyses seek to identify similarities and/or differences related to genetic data collected from other populations that may provide evidence for application of therapies in development and may illuminate novel targets for additional investigation. 

BLAAC PD is a cross-sectional, multi-center study with 11 active sites across the United States seeking to enroll at least 2,000 volunteers (1,000 with PD and 1,000 without PD). Additional sites to achieve this enrollment goal may be added to the study in 2025 or 2026. The study is currently expected to end in December 2027. The study is funded by the Aligning Science Across Parkinson’s initiative and implemented by MJFF. Currently, one entity oversees clinical trial coordination and a second entity manages the study database in REDCap. 

The BLAAC PD study protocol has been published here; since the protocol publication a study amendment has occurred. The most recent protocol can be reviewed here. BLAAC PD study EDC data as well as genotyping and sequencing data are included in and accessible through the larger GP2 data repository. As an example of the critical role these data are playing, data from the BLAAC PD study was utilized in the first major discovery of a novel risk factor for PD in people of African ancestry. Additional information can be found on the BLAAC PD website and ClinicalTrials.gov. 

The selected organization will be responsible for managing the study’s multiple research sites, supporting and documenting each site’s regulatory document submissions, providing training for site study staff, and ensuring continuity of study operations through a smooth transition of oversight.

Objectives and Scope of Work

Objectives:

  • Effectively manage clinical research sites across the United States
  • Provide training and ongoing support for research staff involved in the study.
  • Develop and maintain study documentation.
  • Ensure compliance with regulatory standards (e.g., local IRBs, FDA, ICH-GCP).
  • Prepare and provide proper reporting for study team, MJFF, and study stakeholders.
  • Collaborate with study’s current coordinating organization to ensure seamless transition and continuity of study management.

Scope of Work: The selected organization will be responsible for:

  • Study Site Management:
    • Management of multiple research sites, up to 25 sites.
    • Ensure adherence to study protocols and procedures.
    • Communication with Principal Investigators and site staff.
    • Hold research sites accountable for enrollment goals and data quality.
    • Maintain study documentation and historical information.
    • Track study documentation in a centralized trial management system.
    • Activate new study sites and close study sites, as needed.
    • Collaborate with data management team to ensure data quality.
  • Training and Staff Support:
    • Develop and deliver training materials and sessions for site personnel.
    • Provide ongoing support and troubleshooting to ensure proper implementation of protocol.
  • Study Documentation 
    • All documentation well organized and managed on a cloud platform with properly shared access with the appropriate sites and study team members.
    • Revise study documentation, as needed, to address changes and/or updates to scientific goals, data collection, and other study needs. Including, but not limited to: 
      • Protocol 
      • Informed Consent Forms 
      • Manual of Procedures 
      • Delegation of Authority Log 
    • Maintain a contacts/address list for study. 
    • Maintain record of study supplies (e.g. saliva kits and smell tests) at each site, and manage documentation for purchase of additional supplies for all sites.
  • Regulatory Compliance:
    • Ensure adherence to local regulatory guidelines as the Institutional Review Board of record.
    • Create IRB submission packages for sites to streamline submission of IRB-approved documents to sites’ local IRBs. 
    • Track and document IRB approvals across all sites, including, but not limited to, collecting IRB approval letters and approved documents. 
    • Maintain high standards of participant safety and data integrity.
    • Preparation and submission of required documentation to regulatory authorities.
  • Reporting: 
    • Provide relevant information from sites to the appropriate study leads for effective and prompt decision making. 
    • Prepare periodic progress reports to stakeholders with review and collaboration with the program manager.
    • Collaborate with data management team to send monthly data reports to study team. Required report formats include data tables and Excel spreadsheets provided via email. 
    • Prepare ad hoc data reports as needed by study leads.
    • Collaborate with study teams (e.g. data management team, sites, MJFF, etc.) to ensure thorough understanding of study activities on a regular basis and ability to report and share accurate data and information. 
  • Transition of Study Management: 
    • Partner closely with current coordinating organization to ensure a smooth handover of study oversight and ongoing management responsibilities. 
    • Review and understand current status and progress of the study.
    • Facilitate knowledge transfer, documentation handover, and operational continuity with current coordinating organization. 
    • Document details about the study, including challenges, data discrepancies, and unique site needs that may impact site management for improved transition and effective future management of study needs.
    • Address any transition challenges and ensure there is no disruption in the study.

Proposal Requirements

Please address the following sections and submit a final proposal no more than 5 pages.

The proposal should include the following sections:

  • Organizational Background and Personnel: Please provide a brief description of your organization, team, and professional experiences that directly relate to transition of oversight and cross-sectional, multi-center studies. Please also include copies of key personnel’s resumes (this does not count toward the page limit). Please provide a brief description of your team’s experience with each of the 6 aspects of the scope of work
  • Transition Plan: Please describe your plan for collaborating with the current coordinating organization to smoothly transition oversight of the study. Include a timeline and risk mitigation/management approach in your plan.
  • Study Management Plan: Please provide a general overview of your plan for managing BLAAC PD, including the following key needs: 
    • Clear communication with study leadership and research sites, including reporting progress to MJFF
    • Proactive site monitoring and document organization through trial/document management system
    • Engaging with Institutional Regulatory Boards at each study site with varying needs and tendencies
  • Experience with Similar Studies: Please supplement your proposal with up to three examples of successfully completed projects similar in scope to BLAAC PD, highlighting the areas listed below. If needed, you may generalize details in your example(s).
    • Your responsibilities 
    • Key challenges addressed
    • Risk management strategies (i.e., how you identified and mitigated risks)
    • Key milestones achieved
  • Budget: Using the MJFF budget template, complete a budget to cover services for 1 year. Please include fees for services, site management, and training. 
  • Letters of Recommendation: Please include 1-2 letters of recommendation from individuals/organizations your team has collaborated with, ideally on work similar in scope to BLAAC PD. Letters do not count toward the page limit.

Timeline and Submission Details

Proposal Submission Deadline: Friday, August 8th
Proposal Evaluation Period: Monday, August 11th through Friday, September 12th 
Anticipated Project Transition Period: Monday, October 13th (or as soon as the appropriate agreements are formed and approved) through Wednesday, December 31st
Anticipated Project Start Date: Thursday, January 1st, 2026

Applicants may submit questions by Friday, July 25th to gain additional perspective on project requirements. Please note the MJFF office is closed from Monday, June 30th through Friday, July 4th. Any questions received during that time will be answered promptly once staff return on Monday, July 7th. During the evaluation period, a 30-minute virtual call may be scheduled with your team. 

All questions and proposals should be submitted electronically to:
Naomi Louie
[email protected]