Growth in African clinical research is becoming more visible. More studies are being placed, more partnerships are being announced, and regulatory systems in several countries are evolving. But beneath that momentum sits a quieter question: what determines whether these partnerships deliver high-quality data, build trust, and leave behind stronger institutions once a study ends?
The answer is not scale alone. It is governance.
Across many settings, research delivery still relies on short-term operating models in which external teams enter quickly, activate studies, oversee delivery, and then exit once sponsor needs have been met. These fly-in/fly-out approaches can accelerate start-up, but they do not always leave behind the systems, workforce stability, or institutional ownership needed for long-term research strength.
While this approach can enable rapid activation, it rarely leaves behind the systems, processes, or workforce stability required for sustained research activity (1).
Fragility in Current Operating Models
This challenge is compounded by workforce dynamics. Clinical research depends on trained professionals working within Good Clinical Practice (GCP) standards, yet many organizations still rely heavily on externally placed expertise or project-specific staffing rather than building stable internal capacity. When those individuals move on, the systems they supported often weaken with them. Institutional memory is lost, and each new study begins with avoidable inefficiencies.
At the same time, governance structures within many organizations remain uneven. Quality Management Systems (QMS) are not always fully implemented, and Standard Operating Procedures (SOPs) may exist without being applied consistently across teams and studies. In practice, this means quality can remain dependent on specific individuals rather than embedded in organizational systems.
In practical terms, governance maturity may be reflected in documented escalation pathways, consistent deviation handling, internal audit routines, role clarity, vendor oversight processes, and evidence that systems continue to function despite staff turnover.
Regulatory processes add a further layer of complexity. Multi-step approval pathways, often requiring sequential review across multiple bodies, can extend time to trial activation, a metric that remains important for sponsors and delivery partners (2).
This does not mean scale is unimportant. It means scale without governance is unlikely to be trusted for long.
Why Operational Models Matter
These dynamics matter because operating model choices directly affect research quality, accountability, and continuity. Where delivery models are heavily short-term and externally driven, organizations may struggle to build the contextual understanding, stable teams, and internal discipline required for consistently high-quality execution.
Teams that are not consistently present at site level may be less able to engage participants effectively, anticipate operational bottlenecks, respond to local challenges quickly, or adapt to the realities of routine care. The consequences can include weaker retention, data gaps, slower issue resolution, and lower confidence in delivery.
This matters even more as regulatory expectations evolve. Under the International Council for Harmonisation (ICH) Good Clinical Practice guideline E6(R3), sponsors are expected to apply risk-based oversight across vendors and delivery partners. That places the internal governance of Contract Research Organizations (CROs) and Site Management Organizations (SMOs) directly within scope (3).
What a Governance-First Approach Changes
A governance-first approach changes this trajectory. Evidence from clinical trial capacity-building initiatives suggests that systems are strengthened most effectively when they are developed alongside active research delivery rather than as standalone capacity-building efforts (4).
When organizations invest in documented systems, they create continuity. Processes embedded in QMS and SOPs can persist beyond individual staff members, helping organizations maintain quality across studies, teams, and sponsor relationships.
When teams are locally embedded and stable, research delivery is more likely to improve. Familiarity with site operations, community relationships, referral patterns, and healthcare system constraints strengthens communication and supports more consistent trial execution.
In this context, accountability becomes easier to see. Sponsors and funders are increasingly looking for organizations that can demonstrate consistency across multiple engagements, not just success within a single project.
Organizations that invest in regulatory affairs capabilities are better placed to navigate national and regional frameworks, communicate effectively with regulators, and reduce avoidable delays in study initiation.
What Needs to Happen Next
Several practical shifts would help move African CROs and SMOs toward more durable and trusted operating models.
Funders should broaden how capacity is assessed. Beyond the number of sites activated or participants enrolled, governance maturity should also be evaluated, including QMS implementation, SOP use, audit readiness, role clarity, and internal accountability structures.
For organizations themselves, investing in governance infrastructure before scaling is a strategic choice. It may slow short-term expansion, but it strengthens long-term credibility and makes future growth more sustainable.
Sponsors and global CROs can support this shift by moving away from purely transactional oversight and toward more embedded, continuous partnership models. That includes valuing local governance capability, not just delivery speed.
At a continental level, regulatory harmonization remains important. Initiatives such as the African Medicines Agency may help support more efficient and coherent approval pathways over time, although implementation will continue to vary across countries (5).
There is also a strong opportunity to deepen South–South collaboration. Structured peer learning, mentorship, and exchange between African organizations can accelerate system development and reduce duplication of effort.
ACRN’s Role
Within this broader shift, ACRN’s role is not to stand apart from the ecosystem, but to help strengthen it. By supporting coordination, system development, and more credible partnership models, ACRN is part of a wider movement toward African-led research delivery that is accountable, durable, and built for long-term collaboration rather than short-term execution alone.
Conclusion
Short-term delivery models can generate activity, but they do not necessarily build durability. Organizations that prioritize governance are more likely to build systems that persist, teams that develop, and partnerships that outlast individual studies.
For African-led CROs and SMOs, this is not a secondary organizational issue. It is central to whether they will be trusted as long-term partners in global clinical research. Governance, in that sense, is not separate from growth. It is what makes growth credible.
References
- Bockarie M,MachingaidzeS, Nyirenda T, Olesen OF, Makanga M. Parasitic and parachute research in global health. Lancet Glob Health. 2018 Sep 1;6(9):e964. doi:10.1016/S2214-109X(18)30342-5 PubMed PMID: 30103996.
- Saleh M, Sharma K,ShamshudinA, Obayo I, Gondi S, Karimi N. Regulatory approval of clinical trials: is it time to reinvent the wheel? BMJ Glob Health. 2024 Jan 24;9(1):e013727. doi:10.1136/bmjgh-2023-013727 PubMed PMID: 38267078; PubMed Central PMCID: PMC10823920.
- ICH_E6(R3)_Step4_FinalGuideline_2025_0106.pdf[Internet]. [cited 2026 Apr 8]. Available from: https://database.ich.org/sites/default/files/ICH_E6(R3)_Step4_FinalGuideline_2025_0106.pdf
- Ogutu BR, Baiden R, Diallo D, Smith PG, Binka FN. Sustainable development of a GCP-compliant clinical trials platform in Africa: the malaria clinical trials alliance perspective. Malar J. 2010 Apr20;9:103. doi:10.1186/1475-2875-9-103 PubMed PMID: 20406478; PubMed Central PMCID: PMC2873521.
- African Medicines Agency – Improving access to quality,safeand efficacious medical products for the continent. [Internet]. [cited 2026 Apr 8]. Available from: https://au-ama.africa/