Clinical Operations and Supply Chain Oversight You Can Trust

End-to-End Clinical Trial Supply Chain Management

GH Strategies provides end-to-end clinical trial supply chain management across South Africa, combining operational oversight with SAHPRA-aligned regulatory expertise.

What We Offer

Clinical Trial Site Supply Coordination

Coordinating product supply, returns, and destruction with trial sites to ensure accountability and regulatory alignment.

Import and Export Permit Management

Preparation, submission, and follow-up of SAHPRA and port authority applications for seamless import and export of trial products.

Cold Chain Oversight and Monitoring

End-to-end temperature control solutions for biologics, vaccines, and sensitive products to maintain product quality and compliance.

GxP Vendor Qualification and Oversight

Auditing, qualifying, and monitoring local and international vendors to ensure adherence to GxP and sponsor requirements.

Clinical Supply Chain Risk Assessments

Identifying and mitigating risks across supply chain nodes, from manufacturing to site delivery.

Customs and Logistics Compliance

Navigating customs clearance processes and ensuring compliance with local and international shipping regulations.

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Benefits of Partnering GH Strategies

Reliable Compliance

Always aligned with SAHPRA, ICH-GCP, and sponsor requirements.

Risk Reduction

Proactive identification and mitigation of supply chain risks

Operational Efficiency

Streamlined processes that accelerate study start-up and product availability.

Clinical Trial Supply Chain Management team

How We Work

Our work is driven by clarity, discipline, and a commitment to excellence. We integrate operational precision with clinical and regulatory insight to keep your trial moving efficiently and confidently.

Structured coordination
Transparent communication
Proactive decision-making
High-integrity processes
Consistent documentation
Stakeholder alignment

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Explore Our Services

Frequently Asked Questions (FAQs)

What are clinical operations in clinical research?

Clinical operations include the planning, execution, monitoring, and oversight of clinical trials to ensure regulatory compliance, patient safety, accurate data collection, and adherence to ICH GCP. GH Strategies supports trial sponsors and research organisations with site management, protocol implementation, and operational oversight across African regions.

What supply chain activities are required for clinical trials?

Clinical trial supply chain management includes forecasting, drug ordering, temperature-controlled storage, distribution, import/export permitting, packaging, labelling, and end-of-study drug accountability. GH Strategies manages end-to-end trial logistics, ensuring product integrity from manufacturer to site.

How does GH Strategies support import and export permit applications?

We prepare and submit import/export permit applications, compile supporting documents, liaise with licensed depots and couriers, and ensure all regulatory and customs requirements are met. Our process reduces delays and ensures compliant transport of investigational products, controlled substances, and biological samples.

Why is temperature monitoring important in clinical trial logistics?

Most investigational products require controlled temperatures to maintain stability and efficacy. Deviations can invalidate product batches or compromise patient safety. GH Strategies implements validated temperature monitoring systems, deviation management processes, and root-cause analysis to protect product integrity throughout the supply chain.

What is vendor oversight in clinical operations?

Vendor oversight involves monitoring the performance, quality, and compliance of third-party service providers such as depots, couriers, laboratories, and CROs. GH Strategies provides structured oversight through KPIs, audits, quality agreements, and compliance reviews, ensuring vendors meet ICH GCP, SAHPRA, and sponsor expectations.

How does GH Strategies help sites maintain GCP compliance during trials?

We support sites with protocol training, documentation management, safety reporting processes, informed consent guidance, monitoring support, and audit readiness. Our team ensures trial activities remain aligned with ICH GCP, sponsor requirements, and national regulatory standards throughout the study lifecycle.

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