COVID-19 And Your Clinical Trials
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How A Small Biotech Survived A Virtual Regulatory Inspection During COVID-19
7/7/2020
For a small U.S. biotech company, a Japanese Health Authority (MHLW/PMDA) on-site inspection scheduled in March 2020 would be the first of multiple global regulatory pre-approval inspections of its novel product for treatment of a rare disease. Then COVID-19 happened.
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Remote Monitoring In The Wake Of COVID-19 — Practical & Regulatory Considerations
6/30/2020
In the long term, as we move into the reopening phases of COVID-19, faced with increased expenses and the challenges with on-site monitoring, clinical research professionals need to ensure their quality management systems have the flexibility for the new normal for site management.
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Healing From A Pandemic And Building Resilience Into Future Clinical Trials
6/23/2020
We must now rethink our design strategies and planning processes before starting studies to find the right fit-for-purpose virtual solutions and push the boundaries on our designs to ensure we are collecting what is truly important for research and our patients.
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How Trial Sites & Sponsors Can Deliver On Patient Convenience In The Age Of COVID-19
6/16/2020
For insights on the impact of COVID-19 on patient convenience in clinical studies, and how sites and sponsors should respond, Clinical Leader reached out to Allyson Small, chief operating officer of the Society for Clinical Research Sites (SCRS) and a nearly 20-year-veteran of the healthcare industry.
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Looking Beyond The Pandemic: Ensuring Data Integrity Post-COVID-19
6/4/2020
Trials that have continued through the pandemic are now producing data, and sponsors are having to adapt analysis and reporting strategies to fit their current circumstances. Data integrity is paramount now more than ever. This article shares strategies and processes being utilized by key players in the industry and provides insight into how to best proceed in the future.
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What Patients Are Telling Sites About Trial Participation During COVID-19
5/28/2020
LMC Manna conducted interviews with patients who are currently enrolled in a Phase 3 clinical trial at one of their sites, with questions focusing on the impact of COVID-19 during their trial participation. Here's what they had to say.
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Post-COVID-19 Clinical Trials: Finally Understanding The Meaning Of Patient-Centricity
5/27/2020
Despite being instrumental to our mission of making lifesaving therapies accessible to all, patient perspectives are far too often lost in the wake of “flashier” news about COVID-19 therapy approvals, supply chains, and scientific breakthroughs.
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COVID-19 & The Virtual Trial Rush: Front-Line Insights
5/19/2020
The COVID-19 pandemic caught many sponsor companies and sites unprepared. Clinical trial participants were told to stay home for their own safety and to relieve the burden on site personnel. For companies that had millions invested in trials that required data from those patients, panic set in and the rush was on for new technology solutions.
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Move Virtual Trials From Aspiration To Reality In Today’s Environment
5/14/2020
With the COVID-19 pandemic upon us, we are at a place where the business case is clear, the barriers to adoption are largely removed, and sites and participants alike have begun accepting virtual trials as not just an option but a must.
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COVID-19 & Clinical Trials: Understanding The Long-Term Impact
5/12/2020
While most regulatory agencies have stated an intention to be flexible during these unprecedented times, it is critical that drug developers continue to monitor their risk diligently and develop contingency plans to adapt and respond to factors that affect their clinical development programs.