Tag: COVID-19 10 results

Real-World & Late Phase

Can Your Clinical Data Strategy Keep Pace?

Here we cover the importance of process in ensuring a robust strategy is in place for the acquisition and analysis of trial data in the face of a changing clinical research environment.

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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…

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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…

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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: For more information on Premier’s capabilities, click here.

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INTERACT Meetings: Streamlining Early Clinical Development

In October 2018, the Food and Drug Administration (FDA) issued Standard Operating Policy and Procedure (SOPP) – SOPP 8214 Version 1.0: INTERACT Meetings with Sponsors for Drugs and Biological Products. This document details recommendations for the Center for Biologics Evaluation and Research (CBER)’s engagement with sponsors (such as industry and investigators) in an early development…