Working Together to Expand Clinical Trials in Africa

We were honored to be part of the important discussion in a recent webinar from the African Academy of Sciences — “Strengthening the African clinical trials regulatory and ethics environment” — about extending research to areas where FHI 360/FHI Clinical has worked for decades. Participants included representatives of the AAS, Bill & Melinda Gates Foundation, World Health Organization (WHO) Regional Office for Africa, Novartis and FHI Clinical.

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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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Sustaining Research Capacity at Sites in Limited-Resource Settings: What Can We Learn from Successful Sites?

Keeping a site functional, even in slow times, ensures it is ready as soon as there’s a need. Based on our experience with sites worldwide, we've identified the key areas on which sustainable sites proactively focus.

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