Clinical Insights
Infectious Disease Trials Demand More: Why Sponsors Are Turning to Sub-Saharan Africa for Speed, Scale, and Scientific Certainty
The Infectious Disease Surge
The global infectious disease pipeline is surging. According to multiple industry reports, there are now more drug candidates in development for infectious diseases than for cardiovascular or immunological conditions combined1. From antimicrobial resistance to emerging pathogens, vaccine trials to viral load suppression studies, sponsors are in a race not just against disease—but against time.
But launching and executing these trials is anything but simple. Particularly in Sub-Saharan Africa, where disease burden is high and patient populations are ideal for many protocols, clinical trial execution requires exceptional infrastructure, experienced partners, and a finely tuned logistical strategy. For sponsors aiming to initiate trials or expand sites in the region, the choice of central laboratory partner is a strategic decision with far-reaching implications for trial timelines, data quality, and regulatory readiness.
Here are four key operational challenges sponsors face when running infectious disease trials—and how MLM Medical Labs (MLM) and Cytespace Africa Laboratories (CSAL) are addressing them head-on.
Operational Challenge #1: Trial Startup Delays and Site Readiness
One of the most persistent pain points in infectious disease clinical trials is startup lag. Sponsors often face long delays in getting sites up and running due to regulatory complexities, import/export logistics for lab kits and reagents, and the lack of experienced central lab partners on the ground.
In the infectious disease space, these delays are particularly costly. Trials often aim to enroll patients during acute disease windows or outbreak conditions, and any lag in lab kit readiness or sample processing infrastructure can derail critical timelines.
The MLM + CSAL Solution: MLM Medical Labs, together with its wholly owned facility Cytespace Africa Laboratories in Pretoria, provides in-region kit production, longstanding experience navigating regulatory processes, and established logistics networks across Sub-Saharan Africa. This dramatically shortens site activation timelines—getting trials into motion when timing matters most.
Operational Challenge #2: Fragmented Lab Networks and Data Inconsistencies
In multicenter, multinational trials—especially those with trial sites in Africa—lab data is often siloed across vendors, with no single source of truth. This results in data harmonization challenges, inconsistent SOPs, and delays in database lock.
For infectious disease trials where viral load measurements, immunogenicity profiles, and biomarker panels are central endpoints, data inconsistency introduces significant risk.
The MLM + CSAL Solution: Cytespace Africa Laboratories operates under the MLM Medical Labs global quality framework and feeds directly into a unified, global database. This single-source model means all lab data—whether originating in South Africa or Europe—is captured, processed, and reviewed through a unified global database for consistent oversight.
Operational Challenge #3: Infrastructure Limitations and Sample Integrity Risk
Infectious disease testing often requires complex infrastructure—BSL-3 containment, validated PCR platforms, and cold-chain reliability. Many lab vendors in the region rely on third-party subcontractors, academic, or institutional labs that aren’t built for regulated trial execution.
For sponsors, this introduces risk to both data integrity and regulatory inspection readiness.
The MLM + CSAL Solution: Cytespace Africa Laboratories is one of the only central labs in South Africa with both CAP accreditation and BSL-3 testing capacity. The site also includes ultra-low freezers (−70°C to −86°C) supported by solar + battery + generator redundancies and a real-time monitored biobank. This makes it a true end-to-end facility for infectious disease trials.
Operational Challenge #4: Lack of Disease-Specific Expertise
Sponsors are not just looking for testing—they need labs that understand the disease landscape: TB diagnostics, HIV viral load assays, STI panels, co-infection considerations, and patient safety monitoring. Labs that treat infectious disease trials like general safety testing often fall short.
The MLM + CSAL Solution: MLM + Cytespace Africa Laboratories is purpose-built for infectious disease. Testing capabilities include: – TB culture (LJ + MGIT), microscopy, DST, MIC, QuantiFERON TB Gold Plus – HIV-1/HIV-2 diagnostics, viral load testing, CD4/CD8 immune profiling – Multiplex STI testing, including Chlamydia, Gonorrhea, Trichomonas – SARS-CoV-2 and other viral diagnostics – Full hematology, chemistry, coagulation, and lipid panels
This depth allows sponsors to run both therapeutic and vaccine trials with confidence.
The Strategic Advantage of Sub-Saharan Africa
Sub-Saharan Africa remains one of the most relevant regions in the world for infectious disease research—not only due to high disease burden, but also because of patient diversity, treatment-naïve populations, and real-world relevance.
But tapping into this advantage requires local expertise, regulatory familiarity, and seamless operational execution. MLM and Cytespace deliver all three.
■ Trial-ready lab infrastructure in Pretoria, South Africa
■ Logistics support across 17 African countries
■ In-house regulatory and sample management teams
■ High staff retention and long-tenured scientific leadership
From Sample to Submission: A Central Lab Partner That’s Built for It
From protocol-specific kit production to real-time sample tracking and centralized data reporting, the MLM + Cytespace model eliminates the operational blind spots that too often slow down infectious disease trials.
Whether you’re initiating a new program in Africa or adding African sites to a global protocol, your central lab should not be a limiting factor.
With MLM Medical Labs and Cytespace Africa Laboratories, it becomes a competitive advantage.
Want to see what readiness looks like? Visit our Infectious Disease landing page: https://www.mlm-labs.com/services/infectious-disease-lab/ or contact our team to explore capabilities, timelines, and partnership models.