We support ethical, efficient clinical trials across Africa.
Mission
Our mission is to support the safe, ethical, and impactful execution of clinical research through expert monitoring, site management, and regulatory guidance aligned with global standards.
Vision
We envision Africa as a leading hub for inclusive, world-class clinical research that accelerates innovation and improves global health equity.
Clinical Research Impact
Clinical Trial Management: Multi-country Monkeypox Study 2023
Status: Preparatory Phase (Pre-SIV)
Our team supported the trial preparation across four African countries, overseeing protocol finalization, site activation readiness, and regulatory harmonization.
We coordinated multi-country documentation (ICFs, SOPs, MTAs, insurance, translations) to ensure version control and alignment with protocol and Africa Vaccine Regulatory Forum (AVAREF) requirements.
- Managed cross-functional team meetings with sponsors, data management teams, and site coordinators to track trial timelines, submission milestones, and start-up deliverables.
- Oversaw site selection and pre-study assessments, ensuring readiness for PSVs and subsequent SIVs.
- Supported regulatory strategy development, ethics submission planning, and centralized tracking of approvals and country-specific timelines.
- Maintained up-to-date tracking of regulatory milestones, enabling cross-country progress visibility.
- Facilitated resolution of sponsor and ethics feedback on AVAREF queries and protocol clarifications.
Clinical Monitoring Support: Lassa Fever Cohort Study (on-going)
Scope
Supported clinical trial implementation from site initiation to participant enrolment and follow-up, ensuring protocol compliance, biosample integrity, and >95% early visit completion across 1,000+ participants within four weeks.
Partnered on a fast-tracked clinical study by driving site activation, informed consent compliance, and participant engagement, exceeding enrolment targets and maintaining protocol fidelity throughout early-phase follow-up.
- Supported the study start-up, site activation, and protocol compliance monitoring.
- Supported successful enrolment of over 1,000 community participants, achieving target within 4 weeks.
- Supported bio sample compliance
- Ensured strict informed consent process compliance and documentation
- Supported protocol fidelity with >95% completion rate of early follow-up visits.
African IVD Market Landscape (ongoing)
We are currently conducting a landscape assessment of the IVD equipment distribution market across Ghana, Senegal, and Tanzania for Siemens Healthineers. The objective is to support Siemens Healthineers African market penetration and expansion.
The assessment involves comprehensive engagement with key stakeholders, including medical equipment distributors, ministries of health, public procurement units, regulatory agencies, association bodies, and end-users such as hospitals and diagnostic centres.