Are you looking to expand your clinical trial operations to Nigeria or West Africa?
Do you need a contract research organization in Nigeria that understands the regulatory environment and the research landscape?
United Clinical Trial Support Services (UCTSS) helps sponsors design, develop, and implement clinical trial solutions tailored to their specific needs.
We support sponsors through every stage of the clinical trial process to generate reliable data, maintain regulatory compliance, and make informed decisions.
Why Nigeria and West Africa Should Be in Your Trial Strategy
Nigeria is Africa’s most populous country, with more than 220 million people and a significant burden of disease across infectious diseases, oncology, cardiovascular disease, and other therapeutic areas.
For sponsors, this presents an opportunity to access diverse patient populations while generating data that better reflects real-world populations.
Beyond Nigeria, West Africa offers additional scale through growing research infrastructure, experienced investigators, and increasing regulatory maturity across multiple countries.
Nigeria’s clinical trial ecosystem is governed by two key regulatory bodies.
- NAFDAC (National Agency for Food and Drug Administration and Control) reviews and authorises trial protocols before any study begins, they conduct site inspections and monitor ongoing trials to protect participant safety and data integrity.
In March 2022, the World Health Organization officially recognised NAFDAC as achieving Maturity Level 3 under the WHO Global Benchmarking Tool, reflecting a strengthened regulatory system - NHREC (National Health Research Ethics Committee) NHREC is the apex body for research ethics.
NHREC accredits Health Research Ethics Committees (HRECs) within teaching hospitals and research institutions, ensuring that participant rights, safety, and informed consent remain central to clinical research.
To reduce startup timelines, sponsors can often submit to NAFDAC and the relevant ethics committee in parallel. All clinical trials must also be registered on the Pan African Clinical Trials Registry (PACTR) before study commencement.
What Does a Contract Research Organization Do?
A Contract Research Organization (CRO) provides outsourced clinical research services to sponsors that require local expertise to plan, launch, and manage clinical trials.
For sponsors entering Nigeria, a CRO serves as the bridge between the protocol and the realities of trial execution.
- Regulatory strategy and submissions. Preparing the clinical trial application for NAFDAC, managing ethics committee submissions to NHREC, and tracking approval timelines through to authorization.
- Site identification and qualification. Knowing which hospitals and research centres have the infrastructure, trained staff, and relevant patient population your protocol requires.
- Clinical trial operations. Day-to-day management of site activities: monitoring visits, protocol compliance, and investigator support through the full trial lifecycle.
- Patient recruitment and retention. Community-appropriate recruitment strategies that account for language, geography, and participant trust.
- Data management. Electronic data capture, data quality processes, and audit trail management that meet ICH GCP standards.
- Pharmacovigilance and drug safety. Adverse event collection and reporting to NAFDAC, and ongoing safety monitoring.
- Capacity building. Training investigators, research nurses, and coordinators to the standards international sponsors require
UCTSS: Contract Research Organization in Nigeria and West Africa
United Clinical Trial Support Services (UCTSS) is a contract research organization headquartered in Lagos, Nigeria, that supports early and late-phase clinical trials across Nigeria and West Africa.
We work with pharmaceutical companies, biotechnology sponsors, healthcare organisations, and research institutions seeking a partner that combines local expertise with international standards.
Deep Local Knowledge
Our team understands the operational realities of conducting clinical trials in Nigeria and West Africa.
We understand the regulatory environment, site capabilities, participant recruitment challenges, and practical considerations that influence study success.
We have an established site network.
UCTSS maintains relationships with hospitals, investigators, research nurses, and study coordinators across multiple therapeutic areas.
This enables faster feasibility assessments, site selection, and study startup activities
Technology built for the African context.
Our Clinical Trial Management System, UCTMS, supports trial oversight, documentation, monitoring, and operational workflows.
The platform is designed to work effectively within both established research centres and sites transitioning from paper-based to electronic systems.
Investment in Research Capacity
Through training, mentorship, and workforce development initiatives, UCTSS supports the growth of clinical research capacity across Nigeria and West Africa.
Strong studies require strong sites, experienced investigators, and well-trained research professionals.
UCTSS Services Include:
Clinical Trial Operations and Logistics: End-to-end management of trial conduct from site activation through closeout monitoring, protocol compliance, site management, deviation tracking, and regulatory reporting, all to ICH GCP standards.
Regulatory Affairs: NAFDAC submissions, ethics committee applications, import licensing for investigational products, and ongoing regulatory compliance. We understand how these processes work in practice.
Feasibility Studies: Comprehensive feasibility support site assessment, patient population analysis, and operational planning to give sponsors a clear picture of what running a trial in Nigeria looks like.
Data Management: In collaboration with our sister organization, Dat-a-Life Solutions, we provide the infrastructure and team for electronic data capture, data quality management, and delivery to sponsor standards.
Pharmacovigilance: Adverse event reporting, ICSR generation, PSUR support, and local pharmacovigilance agency services for sponsors running studies in Nigeria.
Working With UCTSS
Every study is different.
The right regulatory strategy, site network, and operational approach depend on your protocol, therapeutic area, patient population, and development timeline.
As a leading clinical research organization in Nigeria, UCTSS can help you assess feasibility, navigate regulatory requirements, and build the operational foundation needed for successful trial execution.
Contact: info@unitedclinicalss.com to get started.
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