COVID-19 And Your Clinical Trials
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Lilly Slams The Brakes On New Clinical Trial Activity
3/24/2020
Conducting clinical trials during the COVID-19 pandemic is no easy task. Recognizing this unfortunate change in events caused by COVID-19, Eli Lilly and Company has made the difficult decision to delay most new clinical study starts and pause enrollment in most ongoing studies.
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FDA Releases Guidance On Conduct Of Trials During COVID-19 Pandemic
3/20/2020
The FDA has released guidance for industry, investigators, and IRBs on the conduct of clinical trials during the COVID-19 pandemic. The agency issued the guidance to provide general considerations to assist sponsor companies with protecting the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing the risks to trial integrity during the pandemic.
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Assessing The Impact Of COVID-19 On Regulatory Interactions, Inspections, & Audits
3/19/2020
While we have not seen any significant delays in regulatory approval of life science products to date, the impact of COVID-19 on regulatory interactions, inspections, audits, and global health authorities is continuing to evolve.
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8 Significant Risks COVID-19 Poses To Clinical Trials — And How To Mitigate Them
3/19/2020
The impact of COVID-19 on clinical trials has been immediate, due to challenges posed by travel bans, hospital/clinic visitation restrictions, and social distancing precautions, just to name a few. These factors have translated into multiple issues that pose challenges related to corporate milestones, budgets, and data integrity.
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Clinical Operations In The Age Of A Pandemic
3/12/2020
The Beat AML (BAML) Master Clinical Trial was focused on efficiency and speed of operations, not on the coronavirus outbreak or pandemics in general. Yet, the model and technologies used by BAML are applicable for biopharma sponsors who want to adapt their clinical operations to support remote monitoring and faster acquisition of data, while preparing for another outbreak or weathering the current crisis.