Site Monitoring & Management in a Clinical Trial of a Spatial Repellent for Vector-Borne Disease Control

The FHI Clinical project team supported site monitoring, site management and project management to assist the University of Notre Dame investigators achieve a level of rigor not typically required for a non-medical product in their double-blinded, randomized-cluster, placebo-controlled clinical trial of a spatial repellent against mosquitoes for malaria prevention.

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What has COVID-19 taught us about the need for unified, cloud-based technology?

The industry’s response to outbreaks like COVID-19 will continue to push advances in technology and influence the way we conduct clinical research. Challenges we’ve faced trying to adhere to impossible timelines and budgets have solidified the need for a technology platform that includes three main characteristics: unified, modular and cloud-based.

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Recovering from the Ebola outbreak in Liberia: Part 3 of the ASTMH blog series

In this third blog post in our ASTMH blog post series, we share information about Liberia’s efforts to recover from the Ebola outbreak, including information presented by Bernice Dahn, Vice President of College of Health Sciences at the University of Liberia, at FHI Clinical’s ASTMH dinner event.

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“A pandemic is a communications emergency as much as it is a medical crisis”

Viruses don’t recognize borders, so it’s important that people and governments don’t either when communicating about an outbreak. Communication across countries, between private companies and government organizations, or between industries can accelerate rapid testing, manufacturing and development of diagnostics, vaccines and therapeutics.

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Without Quality Data, We Cannot Develop Effective Vaccines and Therapies

Quality data are needed to ensure that vaccines and therapies in development are focused on the right targets and deliver the expected outcomes. In the midst of an outbreak, how do we ensure that we have access to patients at sites that are prepared to collect the high-quality data needed for regulatory approval?

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The Sooner, the Better: Planning for FDA Pre-IND Review of COVID-19 Studies

COVID-19 is a perfect example of a novel disease for which there is an urgent need for both vaccines and therapies. To help reduce the application review timelines, the FDA issued guidance for Pre-IND meeting requests in May. We summarize the recommendations and provide advice from our regulatory affairs team.

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Pandemic Preparedness and COVID-19

During an outbreak, epidemiological data help us understand a disease: what, how much, when, where and among whom. With this information, we can analyze a health problem and provide timely information to support decisions for initiating or modifying control and prevention measures.

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Pandemic Experience Means Expert Guidance

When COVID-19 was declared a pandemic, the FHI Clinical team immediately grasped the challenges that the search for vaccines and treatments would present. We’ve been here before, addressing everything from the global threat of malaria to outbreaks of Ebola in West Africa, Zika in the Americas, and chikungunya in the Caribbean during the aftermath of Hurricane Maria. In this blog post, we describe the steps to take and the critical questions to ask.

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Responsive Approaches: Adapting Our Work to the New Realities of COVID-19
Work desk with a lighted lamp and computers, working from home

Responsive Approaches: Adapting Our Work to the New Realities of COVID-19

As FHI Clinical begins supporting rapid start-up of clinical trials vital to containing the spread of COVID-19 and protecting the global community, we are also adapting our ongoing work to the new reality of this global pandemic. We are closely monitoring the situation on the ground in the countries where we work and repurposing team members to support COVID-19 response needs.

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Rapid Site Assessment and Recommendations for Clinical Trials of a New Malaria Treatment

Targeted geographic areas for the development of an antimalarial drug by Novartis included malaria-endemic regions in Africa and Asia, and Novartis requested assistance identifying and assessing potential clinical sites for their planned clinical trial. Our team conducted 38 rapid, in-depth, 2.5-day site feasibility assessments in the 18 countries.

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