PPD helps Gilead conduct COVID-19 remdesivir trials at extraordinary pace

Therapeutic Expertise Infectious Disease PPD Helps Gilead Conduct COVID-19 Clinical Trials
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Hours to deploy global resources

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Research sites initiated in 15 countries

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Patients enrolled globally

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Sites activated in less than 24 hours

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Days from final protocol to first patient in

Background and challenge

Gilead Sciences, a longtime PPD partner, presented an urgent request to initiate global clinical trials of remdesivir, its then-investigational COVID-19 therapy, under an extremely aggressive timeline, given the worldwide pandemic.

The U.S. Food and Drug Administration’s recent approval of remdesivir is a significant milestone – and especially gratifying to PPD because of the opportunity to work with Gilead in following the science, at an extraordinary pace, to help bring forward a treatment for COVID-19 for appropriate patients.

Solutions

PPD has early, direct and ongoing experience managing COVID-19 trials, with global teams working 24 hours a day to rapidly activate research sites, enroll patients and provide myriad research services for multiple clinical studies of potentially life-changing therapies. Our expertise has been especially evident in our work to help support Remdesivir, and we adapted swiftly to adjust country and site mix as the pandemic spread.

Significant accomplishments included

stop-watch
Within nine hours of award, PPD activated one research site after receiving approval on a Friday at 9 p.m. and delivered the investigational product to the site by 6 a.m. the next day, followed by screening patients shortly thereafter.
Within 24 hours of award, PPD immediately deployed dedicated global and country-level human resources.
Within 24 hours of notification, PPD activated two sites in response to a critical need – the rising death toll in a nearby retirement home.
Within 11 weeks of award, PPD had initiated 320 sites in 15 countries and enrolled more than 6,000 patients globally.