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April 28/2020

news roundup

COVID-19 Repository of Patient-Level Data Sets Available

A consortium of healthcare companies have announced the launch of the COVID-19 Research Database, a secure repository of HIPAA-compliant, de-identified and limited patient-level data sets made available to public health and policy researchers to extract insights to help combat the COVID-19 pandemic.



ACCESS for COVID-19 Research Announced

Medable announces a multi-company research framework to accelerate development of diagnostics and treatments for COVID-19. The ACCESS initiative—short for American COVID-19 Collaborative Enabling Seamless Science—provides a mobile consumer application and secure infrastructure to connect health researchers and clinical trial teams securely with up to millions of home-bound individuals in the United States.


Patient-Administered ECG Assessments Available from ERT

ERT has announced a partnership with AliveCor to enable ERT to capture digital cardiac safety data with KardiaMobile 6L, the only FDA-cleared personal ECG for patient-administered 6-lead data collection.


Join CISCRP’s Virtual Medical Hero Appreciation Fitness Challenge!

There is still time to register and participate in the virtual The 2nd Annual Medical Hero Appreci-a-thon to express appreciation for all “Medical Heroes”—medical and healthcare professionals, researchers and study volunteers.


In this edition

ACCESS for COVID-19 Research Announced
NIH Partnership to Prioritize Compounds for Swift Regulatory Review


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Articles

COVID-19 Vaccines: A Tool to Predict and Manage Global Productivity and Risk

In this paper, the authors show a risk-based portfolio simulation that helps uncover the probabilities of a COVID-19 vaccine being approved within a certain number of months or the expectations of managing a global vaccine portfolio approach vs. a company-level or national-level approach using decision support analysis.


How CROs and Sponsors Can Help Sites Now

Clinical SCORE’s recent survey of clinical trial sites show of effects from the pandemic show a dedication to ongoing trials at the site level, but help, guidance and understanding from sponsors and CROs are needed and outlined in this article.


Blog Posts

NIH Partnership to Prioritize Compounds for Swift Regulatory Review

The National Institutes of Health announced a broad public-private partnership to collaborate on prioritizing and coordinating research on COVID-19 drug and vaccine candidates. The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative has support from a number of federal agencies, and some 16 pharma and biotech companies are participating through the Foundation for the National Institutes of Health.

EMA Wins Points for Its COVID-19 Response

The EMA’s activities addressing COVID-19 include the creation of a pandemic task force to manage and coordinate discussions on relevant product development, authorization and surveillance, as well as updated guidance for pharmaceutical companies on developing therapies during the pandemic.

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Lisa Henderson
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LHenderson@mjhlifesciences.com

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Todd Baker
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