The TRACE Core Project Team brings together regional and global partners who work collaboratively to streamline, harmonize, and digitalize clinical trial regulatory and ethics systems across Africa. Their shared mission is to enhance transparency, predictability, efficiency, and collaboration in clinical trial review processes, enabling participating countries to conduct high-quality, ethical, and internationally competitive research.
The Core Project Team is responsible for day-to-day management, strategic guidance, and coordination of all implementation activities. Members include representatives from the Gates Foundation, The MRCT center, AVAREF, Garnet Partners, CIIC-HIN and the national country’s secretariat. Garnet Partners leads project management, coordination, and financial oversight, ensuring timely delivery and consistency across all workstreams. Decision-making is conducted by consensus, with the Gates Foundation holding final decision authority. The Core Project Team convenes monthly to review progress, address challenges, and guide the next steps.
Garnet Partners serves as the core coordination and financial management arm of TRACE. It oversees day-to-day project operations, ensures alignment across all countries, manages timelines and deliverables, facilitates cross-country communication, and supports the overall governance structure to keep the project on track.
Gates Foundation provides the project’s overarching strategic leadership and vision. As the primary funder, the Foundation guides the long-term objectives of TRACE, ensuring alignment with continental regulatory strengthening efforts and supporting impactful, sustainable reforms across all participating countries.
Gates Foundation provides the project’s overarching strategic leadership and vision. As the primary funder, the foundation guides the long-term objectives of TRACE, ensuring alignment with continental regulatory strengthening efforts and supporting impactful, sustainable reforms across all participating countries.
The MRCT Center leads the technical workstreams of TRACE, specifically capacity building, accreditation models, ethics reliance frameworks, and the development of sustainable financing mechanisms for NECs. Their expertise ensures that TRACE activities are grounded in international standards and adapted effectively to country contexts.
The African Vaccine Regulatory Forum (AVAREF) contributes to the harmonization agenda of TRACE by supporting the alignment of national SOPs, review processes, and ethics and regulatory pathways with regional frameworks, and by promoting the adoption of AVAREF-recommended standards and tools.
The African Vaccine Regulatory Forum (AVAREF) contributes to the harmonization agenda of TRACE by supporting the alignment of national SOPs, review processes, ethics and regulatory pathways with regional frameworks, and by promoting the adoption of AVAREF-recommended standards and tools.
CIIC-HIN leads the communication workstream, stakeholder engagement, and national coordination efforts within TRACE. It ensures that information flows effectively across stakeholders, supports visibility and dissemination of project activities, and anchors TRACE implementation within Rwanda while contributing to cross-country communication and technical alignment.
The TRACE Secretariat consists of representatives from national ethics committees and regulatory authorities in each participating country. It ensures that TRACE activities are fully integrated within national systems, coordinates technical inputs from country institutions, and supports the institutionalization and sustainability of reforms at country level.
The TRACE Secretariat consists of representatives from national ethics committees and regulatory authorities in each participating country. It ensures that TRACE activities are fully integrated within national systems, coordinates technical inputs from country institutions, and supports the institutionalization and sustainability of reforms at country level.
The highest decision-making body, responsible for overall strategic direction and resource mobilization for the TRACE Project. The Committee is chaired by a senior executive from the Gates Foundation. Members include African Union Development Agency - New Partnership for Africa’s Development (AUDA- NEPAD), African Medicines Agency (AMA), AVAREF, the MRCT Center, Global Medical Research Institute (GMRI), African Clinical Research Network (ACRN), the Gates Foundation, and Chief Medical Officers or Permanent Secretaries from participating Ministries of Health. The SC meets twice a year.
The highest decision-making body, responsible for overall strategic direction and resource mobilization for the TRACE Project. The Committee is chaired by a senior executive from the Gates Foundation. Members include African Union Development Agency – New Partnership for Africa’s Development (AUDA-NEPAD), African Medicines Agency (AMA), AVAREF, the MRCT Center, Global Medical Research Institute (GMRI), African Clinical Research Network (ACRN), the Gates Foundation, and Chief Medical Officers or Permanent Secretaries from participating Ministries of Health. The SC meets twice a year.
Garnet Partners shall manage the budget, financial reporting, project administration, and compliance with funding agreements.
Dedicated teams for ethics capacity building, regulatory harmonization, digital platform development, financial modeling, and communications.
Deputy Director Africa
Regulatory Systems.
Consultant
Consultant – PMO.
Technical Officer, Implementation Research Portfolio Coordinator
Project Manager
Faculty Director
Director
Director of Medicines and
Pharmacovigilance
Head of Pharmacovigilance and Clinical Trials Division
Executive Secretary
Chairperson
Special Advisor on Research & Innovation
Team Lead, Clinical Trial Analyst
CEO & Founder (CIIC-HIN, PACT and AKIISA)
TRACE Rwanda Project Coordinator
TRACE Communication Project Coordinator