Staying Connected: Successful Site Initiation During the COVID Era

FHI Clinical continues to work with researchers to identify and initiate global sites with the most appropriate capabilities and patient population for study-specific protocols. While the COVID-19 pandemic and its aftermath have presented unique challenges this past year, there are many lessons learned that we can apply to all of our future studies for a larger impact and gained efficiencies.

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Life After Lockdown: On-the-Ground Support for our Liberia Team

A question I often hear is, “What are you most looking forward to after lockdown?” My answer relates to something that happened just as the pandemic was taking off in the United States last year: FHI Clinical was awarded the oversight of the Partnership for Research on Ebola Vaccines in Liberia (PREVAIL) Network and had to recruit, hire and train over 200 staff in Liberia to manage the PREVAIL work. Due to travel restrictions and the unknown risks of COVID, we had to do this remotely.

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2020 WOCIP Annual Conference: Educating, Empowering and Elevating Women of Color in Pharma Worldwide

“Educate, Empower, Elevate!” was the theme for the most recent conference for Women of Color in Pharma (WOCIP), a nonprofit aiming to promote the development and advancement of women of color who are employed in the pharmaceutical industry. We asked FHI Clinical team members, Tafoya Hubbard and LaTonya Jones to share some thoughts about their experiences during the 2020 two-day virtual event.

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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 Elusive COVID-19 Patient: Subject Recruitment Remains Challenging Despite Increasing Case Numbers

FHI Clinical has found that our sponsors and our own teams face a number of challenges to patient recruitment in COVID-19 trials. In this blog post, we discuss these limitations and how FHI Clinical is working with sponsors to develop strategies to address them.

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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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