STUDY TYPE
Phase 2b clinical trial
LOCATION
Africa
CLIENT TYPE
Public-Private Partnership
Overcoming challenges in clinical trials in low-resource settings
The client contacted us for support with their Phase 2b trial, to evaluate the safety and immunogenicity of their vaccine in HIV-positive and HIV-negative adults, followed by a randomized, placebo-controlled pediatric phase.
While the science was robust, the operational landscape brought challenges common to fast-moving clinical trials in low-resource settings, including:
- Variations in site facilities and capabilities.
- Rapid recruitment of participants within the first two weeks increasing the risk of potential site errors prior to the first monitoring visits.
- High monitoring workload due to fast-paced enrollment with a 100% SDV requirement, creating pressure on timelines.
Our client needed a partner who could bring structure and consistency, whilst preserving the recruitment momentum and upholding data integrity and participant safety.
Our approach to enabling clinical trial success in Africa
Stabilizing the Study in a Rapidly Moving Environment
P95 deployed a dedicated CRA team with deep regional experience to bring consistency across all three South African sites. Through frequent site re-training, optimized emergency procedures, and SOPs tailored to site capacity, we maintained trust, and optimized trial flow.
To manage the high volume of data monitoring and to ensure participant eligibility and safety, we introduced a risk-based approach to our monitoring strategy. This eased the initial SDV burden during high enrollment periods while safeguarding critical data. This strategy, as approved by Sponsor, allowed our CRAs remained agile, responsive, and focused on participant safety.
Improving Documentation and Safety Oversight
From pre-activation through study execution, P95 worked closely with site teams to align and improve source documentation practices, including around informed consent and medical event tracking. A standardized quality control (QC) process was embedded into each participant visit to reduce transcription errors.
To strengthen safety oversight, we developed tools for real-time reporting of Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs). CRAs ensured adherence to ALCOA+ principles and supported site compliance with ethical and regulatory standards.
Addressing Start-Up Delays and Multi-Party Complexity
P95 helped its client to accelerate site readiness and identify recruitment risk areas early. We streamlined communication, clarified stakeholder responsibilities, and provided retraining where needed.
Results & impact: building clinical trial capacity in Africa
Through proactive monitoring and adaptive trial management, P95 delivered:
- Low protocol deviation rate thanks to early CRA engagement
- High participant retention rates
- High levels of site confidence through a stable, trained monitoring team
- Improved documentation quality and SOP adherence
- Stronger emergency readiness and real-time safety reporting
- A scalable monitoring strategy that supports the client’s broader trial portfolio
- Flexible monitoring teams to include junior staff overseen by senior CRA’s to increase efficiency and outcomes whilst building capacity and growing resources.
Beyond this study, P95 helped this client implement tools like Veeva CTMS for project and site management trend analysis and portfolio oversight and trained cross-functional teams for future trial readiness across Africa and beyond.
“P95 demonstrated exceptional agility and responsiveness in adapting to the evolving needs of the project”
Why it matters
This case study showcases how P95 enables global sponsors to conduct clinical trials in low-resource settings without compromising on quality or timelines. Our hybrid model blends local expertise with global standards, empowering your research to reach the populations that need it most.
Ready to enable your trial in low-resource settings?
Planning a vaccine study, early-phase program, or community-based research in Africa or similar setting? We are here to help. Contact us to learn how P95 can support your clinical trials in low-resource settings.
FAQ
Here are some answers to Frequently Asked Questions.
What makes running clinical trials in low-resource settings particularly challenging?
Trials in these environments can face hurdles such as limited site facilities and capabilities, , and complex multi-party coordination. Without strong oversight and adaptive monitoring, data integrity and participant safety can be at risk.
How did P95 ensure data quality and regulatory compliance in this African vaccine study?
P95 deployed regionally experienced CRAs, embedded risk-based monitoring, and standardized quality checks at every visit. This approach safeguarded critical data while keeping participant safety front and center.
What impact did P95’s approach have on trial performance and outcomes?
The study achieved low protocol deviation rates, high participant retention, and improved documentation quality. P95’s proactive monitoring also built site confidence and created a scalable model for future trials across Africa.
Why should global sponsors partner with P95 for trials in low-resource settings?
P95 has over 25 years of experience conducting clinical trials in low-resource settings including Africa. Their local expertise combined with global standards, enables sponsors to execute complex and fast-paced studies without compromising quality or timelines. Their flexible, capacity-building model ensures both immediate trial success and long-term readiness.
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