COVID-19

COVID-19

COVID-19 Update: What Sponsors Need to Know About the New FDA Guidance

With the emergence of the COVID-19 pandemic, we are all experiencing uncertainty. This uncertainty is impacting our personal lives, and it’s also impacting and reshaping the critical research biotech and specialty pharma companies are conducting. In the first of a special new podcast series, hear from Nach Dave, Premier Research’s Vice President of Development Strategy,...

COVID-19

Statistical Considerations for FDA COVID-19 Guidance

In response to the newly released U.S. Food and Drug Administration (FDA) guidance on COVID-19, the Statistics Department at Premier Research has committed to highlighting specific and necessary actionable considerations that directly address key FDA recommendations in the guidance. These considerations call attention to some general actions required to ensure the operational integrity and scientific...

COVID-19

What Is FDA’s Emergency Use Authorization (EUA) and How Can It Help Develop Therapies Faster?

As we continue to face health emergencies and imminent threats to our safety and well-being, the medical community is tasked with bringing solutions to the patients in an expedited and safe manner. One such opportunity is to partner with the US FDA by submitting an Emergency Use Authorization (EUA) for any products that could immediately...

COVID-19

Global Health Authorities Push for Rapid Development of COVID-19 Tests, Drugs and Vaccines

In response to the Coronavirus Disease 19 (COVID-19) pandemic, the scientific community, industry, and regulatory agencies are pulling together to facilitate the development of diagnostic tests, drugs, and vaccines to help prevent the spread of the disease. The timelines for development of new drugs and vaccines normally take years. In light of the situation, however,...

COVID-19

FDA Issues Guidance on Clinical Trials During COVID-19

Earlier this week, the FDA issued a guidance on the conduct of clinical trials during the ongoing Coronavirus Disease 2019 (COVID-19) pandemic. “The FDA released this guidance to emphasize that at all times, patients’ safety should continue to be at the forefront of considerations,” said Anand Shah, M.D., FDA Deputy Commissioner for Medical and Scientific...

COVID-19

Considerations for Ensuring Trial Continuity in the Wake of COVID-19

We’ve gathered questions from our customers and vendors regarding potential impact of COVID-19 on current and planned studies. Although we may not have answers for every situation, here are some areas that we are keenly focused on to support our sponsors: Talk to your CRO about CRA travel limitations and impact to on-site site qualification...