Eight sites actively recruiting patients for CYNK-001 COVID-19 therapy trial

December 4, 2020 Phase I/II studies to evaluate human placental hematopoietic stem cell–derived natural killer (NK) cell therapy to treat COVID-19 in hospitalized adults are currently ongoing as part of our partnership with the Infectious Disease Research Institute (IDRI).

Continue Reading Eight sites actively recruiting patients for CYNK-001 COVID-19 therapy trial

ACTT-2 findings support FDA emergency use authorization for baricitinib + remdesivir to treat COVID-19

November 20, 2020 The U.S. FDA granted emergency use authorization (EUA) for the use of baricitinib in combination with remdesivir to treat COVID-19 in hospitalized adults and children at least two years of age requiring supplemental oxygen, invasive mechanical ventilation or extracorporeal membrane oxygenation.

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Building tuberculosis research capacity through the China Tuberculosis Clinical Trials Consortium (CTCTC) network

October 16, 2020 Development and ongoing activities of the China Tuberculosis Clinical Trials Consortium (CTCTC) were described in an article published in the Infectious Diseases of Poverty journal earlier this year. Read more, including FHI Clinical's role in providing the network with technical support and guidance for clinical trial capacity building.

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FHI Clinical and Oracle bring critical clinical trial capabilities to markets in need

October 12, 2020 Oracle Health Sciences and FHI Clinical Inc. have joined efforts to improve clinical trial efficiency and help get therapies to market faster. FHI Clinical has adopted Oracle Health Sciences Clinical One for randomization, supply management, and data collection; Oracle Argus Safety for safety case management; Oracle CTMS Cloud Service to manage the entire research portfolio; and Oracle ClearTrial Cloud Service to help budget, plan and bid on projects.

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Remdisivir superior to standard care for hospitalized adults with COVID-19: Final ACTT-1 results published in NEJM

October 8, 2020 Final results of the Adaptive COVID-19 Treatment Trial (ACTT)-1 investigating remdesivir for the treatment of COVID-19 in hospitalized adults with evidence of lower respiratory tract involvement have been published in the New England Journal of Medicine (NEJM). Of the FHI Clinical study team members, Danielle Fisher, Clinical Research Project Manager, and Wendi McDonald, Associate Project Manager, are listed on the manuscript for their contributions to the study.

Continue Reading Remdisivir superior to standard care for hospitalized adults with COVID-19: Final ACTT-1 results published in NEJM

FHI Clinical Inc. expands support role in PREVAIL clinical research network to include full operational management

September 16, 2020 The operational goal is to provide experienced oversight while advancing the Partnership for Research on Vaccines and Infectious Diseases in Liberia (PREVAIL) network toward long-term, local self-sustainability - to conduct high-quality research with a focus on emergent and high-impact public health research priorities in Liberia.

Continue Reading FHI Clinical Inc. expands support role in PREVAIL clinical research network to include full operational management

FHI Clinical works with new partners to help mitigate effects of COVID-19

August 4, 2020 FHI Clinical is pleased to announce our partnership with Tiziana Life Sciences to expedite clinical development of TZLS-501, a novel fully human anti-interleukin-6 receptor (anti-IL6R) monoclonal antibody (mAb), for the treatment of COVID-19 (SARS-CoV-2) patients.

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Outsourcing-Pharma: FHI Clinical to support ACTT remdesivir trial for COVID-19

July 23, 2020 Claudia Christian of FHI Clinical recently spoke with the editor for Outsourcing-Pharma about the clinical services that FHI Clinical is providing to the Frederick National Laboratory for Cancer Research for the ongoing ACTT adaptive study allowing investigation of putative therapeutics for the treatment of COVID-19 in hospitalized adults.

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FHI Clinical Inc. providing clinical operations services for ACTT-1 trial of remdesivir for treatment of COVID-19

July 14, 2020 FHI Clinical Inc. announced that it has a subcontract with the Frederick National Laboratory for Cancer Research, currently operated by Leidos Biomedical Research, Inc., to provide clinical operations services for the Adaptive COVID-19 Treatment Trial (ACTT). ACTT is an adaptive study to allow investigation of putative therapeutics, for the treatment of COVID-19 in hospitalized adults.

Continue Reading FHI Clinical Inc. providing clinical operations services for ACTT-1 trial of remdesivir for treatment of COVID-19