Pharmalys is an international Clinical Research Organisation (CRO) with a diverse team distributed across Europe, Asia, North America and Africa. Within our global portfolio, we support the execution of numerous clinical trials (CTs) in Africa. Across these projects, the experience, flexibility and responsiveness of our staff – from Project Managers (PMs) and Clinical Trial Managers (CTMs) to Clinical Research Associates (CRAs) and Clinical Research Assistants (CTAs) – are essential to consistently meeting clients’ expectations and requirements.
Executing clinical trials anywhere demands rigour, but doing so in Africa requires an additional level of operational resilience and adaptability. From navigating complex regulatory landscapes to ensuring CTs begin without avoidable delays or costly missteps, our focus is operational excellence: enabling trials to run smoothly, efficiently, and transparently. Our teams are trained to respond effectively to unexpected challenges, allowing us to consistently meet sponsors’ expectations and study timelines.
Several Pharmalys team members operate both in the Global North and Africa, and their comparative experience highlights an important reality: working as a clinical research professional in Africa requires a broader skill set and a remarkable ability to adapt to constantly evolving operational environments. This context creates a unique setting which technical expertise must be complemented by exceptional agility.
Regulatory and Ethics Approvals
Obtaining clinical trial approval from Regulatory Bodies (RBs), Research Ethics Committees (RECs) and Institutional Review Boards (IRBs) represents a major milestone in CT implementation. In contrast to the Global North – where regulatory pathways and ethics submissions are typically standardised, and timelines are often benchmarked to predictable service levels – submission processes in Africa can vary significantly by country and over time.
In this dynamic environment, our clinical research professionals maintain up-to-date intelligence on regulatory guidance and develop realistic start-up plans that incorporate appropriate contingencies. They remain prepared to respond swiftly to unexpected changes, bridge communication gaps and anticipate bottlenecks.
To further support this ecosystem, Pharmalys has established two dedicated units: Capacity Building & Strengthening, and Regulatory Affairs & Study Start-Up. Our specialists remain fully current with global regulatory developments and deliver tailored training programmes to RECs and national authorities. Beyond executing studies, we actively contribute to strengthening local research systems -work that our CRAs bring to life on the ground every day. Contact us today to find out more about these units
Supporting Site Excellence
Pharmalys staff consistently demonstrate a high level of operational agility. Monitoring clinical trials in Africa requires meticulous planning and strong organisational skills. Once studies are ready to launch, day-to-day execution is shaped by operational realities on the ground. Our teams must account for long flight durations due to limited connections between African countries; travel time to research centres located far from capital cities or scattered across regions; and the length of on-site stays, as monitoring visits often extend over several days because of the high recruitment potential at many African sites.
These are not obstacles, but operational parameters that our experienced teams integrate into their monitoring strategies and risk-based oversight plans. With notable endurance and adaptability, our CRAs maintain precision in their work despite logistical constraints, ensuring protocol compliance, adherence to GCP, application of SOPs, and continuous inspection readiness.
In contexts where research centres may have limited infrastructure or experience, our teams naturally assume broader responsibilities. Beyond routine monitoring activities, Pharmalys CRAs often become mentors to site staff, providing:
- GXP training
- Hands-on guidance and capacity building on essential records and maintenance of the Investigator Site File (ISF)
- Practical support in pharmacovigilance and quality processes
Our teams therefore act as partners who uplift research capacity while safeguarding participant safety and data integrity. This expanded role is essential for ensuring sustainable research quality and preparing sites for long-term participation in global clinical trials.
Clinical Research: The Future Is Africa
Africa represents 18% of the world’s population and 23% of the global disease burden, yet accounts for only around 3% of global clinical trial activity. However, the clinical research landscape is rapidly evolving, and Africa is increasingly recognised as essential to the global clinical research agenda. This momentum is driven by:
- Expanding medical and research infrastructure
- Maturing regulatory frameworks
- Unique and rich genetic and epidemiological diversity
- Large pools of potential participants
- Competitive operational costs
However, infrastructure alone does not deliver quality research – people do. The dedication and adaptability of African clinical research teams are already helping sponsors run successful studies in complex environments.
Africa is not just a promising destination for clinical research – it is integral to the future of evidence generation. The opportunity is clear: investing in the teams and systems that already deliver under complexity will unlock faster and more inclusive research outcomes.
It is time to #CountAfricaIn
