Newsletter | April 12, 2025

04.12.25 -- Clinical Leader Best Of March

MARCH'S BEST FEATURED EDITORIAL

FDA Issues Draft Guidance On The Use Of AI To Support Regulatory Decision-Making For Drug And Biological Products

The U.S. FDA issued a draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. The public comment period ends April 7.

Should We Be Paying Clinical Research Participants?

Eduardo F. Motti, MD discusses patient payment from a global perspective, arguing that patient payment isn't thought of the same way around the world as it is in the U.S.

Government Contract Advances Walgreens In Clinical Space

Walgreen’s new $25 million deal with BARDA (Biomedical Advanced Research and Development Authority) is a huge win for the pharmacy chain. John Campbell, head of DCTs at Walgreens, explains the ins and outs of the study and what could be next for the company regarding its clinical trials division.

MARCH'S BEST INDUSTRY INSIGHTS

Understand The FDA's Push For More Representation In Clinical Trials

Take action to improve diversity in clinical trials by addressing underrepresentation and ensuring equitable access to medical interventions, as emphasized by the FDA’s new 2025 guidance.

5 Best Practices For Getting Started With ePRO

Unlock the potential of electronic Patient Reported Outcomes (ePRO) in your clinical research by implementing these essential best practices for success.

Accelerating Site Activation: Examples From Novartis And IQVIA

As protocols and studies become more complex, using technology to offer sites in-depth expertise and guidance is more important than ever to launch studies on time.

MARCH'S BEST SOLUTIONS

GxP Quality Assessment And Remediation

Data Management Solution For A Clinical-Stage Cancer Immunotherapy Study

Answer Your Critical Clinical Questions — Faster Than Ever

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