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Solving Cold Chain Issues for the <br>Most Pressing Public Health Challenges

Solving Cold Chain Issues for the
Most Pressing Public Health Challenges

Helping Public Health CROs optimize the cold chain and ensure clinical trial compliance in some of the world’s most difficult environments

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Cold Chain Challenges for Clinical Trials in Developing Countries

Getting vaccines and therapies tested and deployed in developing countries is a critical humanitarian effort that can save lives. But it requires working in high-risk environments, against obstacles like extreme weather, local conflict, and a lack of infrastructure. We rely on the fundamental procedures, equipment, and assumptions to address critical situations like temperature-sensitive drugs, biological specimens, and lab reagents. In these unique environments, proper cold chain assessment and readiness planning are vital.

Who can benefit from cold chain operations and facilities engineering support for clinical trials?

  • You’re running a trial in extreme operating environments, like climatic zones III & IV.
  • You’re running a trial in an area with unreliable power or road infrastructure, the potentialfor local conflict, or other obstacles.
  • You want a partner with extensive in-region and in-country experience within Africa and other challenging environments.
  • You need to assess and optimize the vaccine storage and distribution capabilities of treatment centers and other facilities in developing areas
  • You need to mobilize fast on your clinical trial

How Modality Solutions Can Help

Modality Solutions partners with the many specialists who ensure patient populations outside the US have ready access to safe, effective vaccines and therapeutics. CROs, government agencies, industry sponsors and other NGOs turn to Modality Solutions for our extensive experience assessing, validating, and optimizing the cold chain in challenging environments, including climate zones III & IV (extremely high temperature and humidity). Modality Solutions provides the in-country expertise and technical capabilities to optimize the clinical trial cold chain in the most challenging environments, bringing safe, effective therapies to populations that sorely need them.

Success is in the numbers – our efforts resulted in:

  • Eight months of on-site, in-country support for a vaccine trial in Sub-Saharan Africa, with zero doses lost to temperature excursions.
  • With < two weeks’ notice, deployed pharmaceutical cold chain experts to Sub-Saharan Africa for clinical trial consulting and support.
  • Three storage facilities in Liberia achieved robust cold chain capabilities to support Ebola vaccine clinical trials.
  • Four Ebola treatment centers in the Democratic Republic of the Congo (DRC) evaluated, with proper cold chain processes established and equipment qualified

Case Studies

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FHI 360 Case Study:

Creating a Comprehensive Cold Chain Strategy for Ebola Vaccines in Sierra Leone

Supporting an Ebola vaccine trial in Sub-Saharan Africa, FHI 360 needed to ensure the cold chain was up to the challenge of a resource-limited environment, a deep-frozen formulation, and a complex distribution..

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Leidos Biomedical Research Case Study:

Cold Chain Assessment of Ebola Treatment Centers in the DRC and Liberia

When an Ebola epidemic hit the DRC in 2018 and rapid vaccine deployment was vital, Leidos Biomedical Research turned to Modality Solutions. Our specialists spent eight months on site, leading a team o..

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Why Public Health CROs
Partner with Us

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  • Vast experience tackling the Ebola challenge in the Democratic Republic of Congo (DRC) and Liberia, and Sierra Leone, and Guinea
  • Deep domain expertise with COVID-19, supporting 40% of vaccines and therapies in development
  • Successful partnerships with many sponsors and agencies working in the region, including Leidos Biomedical Research, FHI 360, FHI Clinical, WHO, The Mitchell Group, NIAID, BARDA, NIH and the CDC
  • Unrivaled expertise in evaluating facility readiness to store and distribute temperature-sensitive vaccines and other materials in high-risk environments
  • Extensive experience developing SOPs and contingency plans—providing stability, consistency, preparation for the unknown, and a foundation for future projects
  • Proven track record of identifying and addressing cold chain deficiencies that create drug efficacy and safety risks and threaten humanitarian work
  • Recognized thought leadership in the global vaccine field, with experts who speak and comment on cold chain challenges in emerging markets

Our Solutions to Support Global Public Health Initiatives

Clinical Trial Operations

Clinical Trial Operations

Our pharmaceutical cold chain experts provide in-country support for vaccine clinical trials in challenging environments across the globe—providing end-to-end support designed to maximize clinical trial performance, data integrity, and patient safety.

Engineering Consulting Solutions – Consulting & Risk Assessment

Engineering Consulting Solutions – Consulting & Risk Assessment

Our regulatory and technical expertise sets a foundation for your clinical trial success—with GDP and hazard risk assessments, facility compliance and readiness evaluation, technical recommendations, regulatory document review/preparation, and SOP development and training.

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Engineering Consulting Solutions – Thermal Packaging Testing

Engineering Consulting Solutions – Thermal Packaging Testing

Modality Solutions can conduct rigorous, comprehensive testing of your therapeutic against a wide range of ASTM and ISTA standards at our independent Advantage Transport Simulation LaboratoryTM or a third-party lab—ranging from plunger movement studies to confirm sterility and efficacy, to drug-device functionality testing, and many other applications.

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Did You Know?

69%

69% of deaths in Sub-Saharan Africa are caused by infectious diseases

2%

One-quarter of the world’s disease burden exists in Africa, but it has only 2% of doctors and fewer engineers

80%

About 80% of Africans rely on public health facilities

Unique Capabilities We Can Put to Work For You

Cold Chain Engineering

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Transport Simulation Lab

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AI-Driven Cold Chain Optimization

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Emergency Response to Regulatory Inquiries

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What Our Clients Say

“Dan Littlefield led a team from Modality to oversee the cold chain operations for a potential vaccine that required -80C storage. The environment was austere, electricity was unreliable, and there was no local expertise with cold chain management. Dan brought his technical competence and creative thinking to managing cold chain operations and equipped local staff with the skills to keep freezers running, the vaccine cold, and trial operations running smoothly“.

Ted FitzGerald, CEO, FHI Clinical Inc.

Ted FitzGerald, CEO, FHI Clinical Inc.

Ready to discuss cold chain needs
for your clinical trial?

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Ready to discuss cold chain needs <br>for your clinical trial?

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