Oncology patients face a difficult journey — a frightening diagnosis followed by intricate and oftentimes burdensome treatment regimens with uncertain outcomes. One patient struggles to take the correct dosage at the prescribed times through the “brain fog” caused by his...
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Real-World & Late Phase
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...
In a previous blog post, we discussed some significant changes to over-the-counter (OTC) product regulations put into place by the passage and signing into law of the CARES Act. The previous post focused on the most attention-getting OTC component of...
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...
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...
Tucked away in the nearly 900 pages of the Coronavirus Aid, Relief, and Economic Security (CARES) Act just passed is the addition of Section 505G to the Food, Drug, and Cosmetic Act. This section makes substantial changes to the statutory structure and...
As a regulatory affairs professional advising various stakeholders on the interpretation and implementation of guidance documents from the FDA, I can safely say that the task is challenging in the best of cases. FDA guidance documents have a tendency to...
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 highlight specific and necessary actionable considerations that directly address key FDA recommendations in the guidance. These considerations call attention...
On January 31, 2020, the Secretary of Health and Human Services (HHS) declared a national emergency to combat the COVID-19 pandemic caused by the novel coronavirus SARS-CoV-2. As a result, the FDA is authorized to grant Emergency Use Authorizations (EUAs)...
During these challenging times when the world is focused on COVID-19 and the matters at hand, it’s understandable if you didn’t take much notice of March 23 as a significant date – one that’s been on the FDA’s radar for...