The Clinical Trials Unit (CTU) at MRC Unit The Gambia (MRCG) operates as an Academic Clinical Research Organization (ACRO), delivering high-quality, end-to-end clinical trial solutions across West Africa. Acting as a central delivery hub, the CTU integrates and mobilizes MRCG’s full spectrum of in-house expertise—including clinical scientists, laboratory specialists, data managers, trial monitors, and statisticians—to provide seamless, sponsor-ready support across the entire trial lifecycle.

This model enables us to combine the scientific rigor of a leading academic institution with the efficiency, quality standards, and operational delivery expected of a commercial CRO, underpinned by over 20 years of proven experience in conducting clinical trials in diverse and complex settings.

End-to-End Clinical Trial Services

We provide comprehensive operational and scientific support to both investigator-led (academic) and industry-sponsored clinical trials, spanning Phase I to Phase IV across vaccines, therapeutics, and nutritional interventions.

Study Design and Scientific Support

• Protocol development led by experienced clinical scientists
• Statistical design and SAP development
• Randomization module development
• DSMB reports, TLFs, and final analysis
• Clinical Study Report (CSR) writing support

Trial Preparation and Set-Up

• Site identification, feasibility, and qualification
• Trial set-up and regulatory readiness
• TMF and ISF set-up and management

Trial Delivery and Oversight

• Full trial and site management
• Onsite, remote, and risk-based monitoring
• GCP-aligned quality assurance

Data Management and Digital Systems

• 21 CFR Part 11-compliant database and eCRF development
• End-to-end data management
• REDCap expertise and collaboration with global partners

Laboratory and Sample Management

• GCLP- and ISO-compliant laboratories
• Central lab services
• Large-scale biobanking capacity

Training and Capacity Strengthening

• GCP and clinical trial operations training
• Bilingual delivery (English and French)
• Long-standing contribution to regional capacity building

Regional Reach and Experience

Extensive experience across West Africa including The Gambia, Burkina Faso, Mali, and Nigeria.

We have played a pivotal role in establishing and strengthening GCP-compliant clinical trial sites across the region, supporting sustainable research ecosystems and epidemic preparedness.

Our Track Record

We have partnered with leading global academic institutions and industry organizations, including:

• University of Oxford
• European Vaccine Initiative
• Serum Institute of India
• Micron Biomedical

Why Work With Us

• Full-service ACRO model: from protocol to publication
• Proven delivery across Phases I–IV
• Integrated scientific, operational, and laboratory capabilities
• Deep regional expertise in West Africa
• Cost-effective, high-quality delivery in resource-diverse settings
• Strong commitment to capacity strengthening and long-term partnerships

Selected Experience and Case Studies

Multicountry Vaccine Trial Delivery

Scope: Phase II/III vaccine trial across multiple sites in West Africa
Our Role: End-to-end operational delivery (set-up, monitoring, data management, lab coordination)
Key Achievements:

• Rapid site activation across multiple countries within tight timelines
• 95% participant retention rate
• High data quality with minimal queries at database lock
• Successful delivery in compliance with GCP and sponsor requirements

Academic Trial Support

Scope: Investigator-led clinical study with complex data requirements
Our Role: Protocol development, database design, data management, and statistical analysis
Key Achievements:

• Development of 21 CFR Part 11-compliant eCRF and database
• Efficient data cleaning and database lock within planned timelines
• Delivery of Statistical Analysis Plan (SAP), DSMB outputs, and final analysis package
• Contribution to timely dissemination and reporting

ARC-WA Capacity Strengthening

Scope: CEPI-funded Advancing Research Capacity in West Africa (ARC-WA) project
Our Role: Lead implementation of clinical trial preparedness and site strengthening

Key Achievements:

• Established and strengthened GCP-compliant clinical trial sites in:
  • ATBUTH Bauchi (Northern Nigeria)
  • FMC Owo (Central Nigeria)
• Delivered comprehensive capacity building across all workstreams, including:
  • Workforce training (clinical, regulatory, data, and operations)
  • Infrastructure and systems strengthening
  • Development of standard operating procedures aligned with international standards
• Designed and operationalized a mobile Clinical Trials Unit (CTU) model to support rapid deployment and trial readiness in outbreak-prone settings
• Positioned sites for participation in Phase III vaccine trials and future epidemic response research

Contact details

For general enquiries:

Email: [email protected]