COVID-19

Data Management & Biostatistics

Real-World Data and Real-World Evidence: What Is Their Value as a Synthetic Control Arm?

In times of crisis, there is often value in taking a step back and reassessing some of the traditional ways of doing things. As the clinical research community tackles the issues COVID-19 has raised for ongoing and future studies, we at Premier Research are meeting the challenge of developing alternative paradigms and new ways to...

COVID-19

Leveraging Emergency Use Authorizations to Bring COVID-19 Products to Market

With the emergence of the COVID-19 crisis, the scientific and medical communities have been tasked with bringing diagnostic and treatment modalities to patients in an expedited but safe manner. To help address this critical need, the Secretary of the U.S. Department of Health and Human Services (HHS) has declared a number of Emergency Use Authorizations...

COVID-19

PREMIER VOICES #11: Statistical Considerations in the Wake of COVID-19

COVID-19 has dramatically changed the way we conduct clinical trials and left many sponsors without answers when it comes to the future of their studies. Recognizing the issues is one thing, but figuring out where we go from here demands a new way of looking at some common challenges. In this episode, Premier Research’s Shari...

COVID-19

Data Driven: How Electronic Patient-Reported Outcomes (ePROs) Provide a Vital Opportunity to Capture Key Data Beyond the COVID-19 Crisis

Traditionally, the use of patient-reported outcome (PRO) data has been an adjunct to primary data when it comes to clinical trials; however, in the current environment, reliance on PRO models has gained steam. As the FDA and research community continue to evolve in terms of how and what data gets captured during the COVID-19 pandemic,...

COVID-19

PREMIER VOICES #10: COVID-19 Update – How the FDA's Emergency Use Authorization Can Help Develop Therapies Faster

As we continue to face the ongoing COVID-19 health emergency, the medical community is tasked with bringing solutions to 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 and effectively address a health emergency....

COVID-19

COVID-19 & Clinical Trials: Direct-to-Patient Model Keeps Research Moving and Patients Safe

In an effort to maintain the continuity of our clinical trials during the COVID-19 pandemic, Premier Research is helping customers take steps to safeguard the well-being of patients who were previously expected to go to a medical facility to receive treatment. A Direct-to-Patient (DTP) model applies only to studies for which the sponsor has had...

COVID-19

PREMIER VOICES #9: 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,...