As clinical trials evolve in the digital age, e-consent has emerged as a promising tool to enhance patient engagement, streamline processes, and improve regulatory compliance. While the benefits of e-consent are significant, implementing this technology also presents several challenges that sponsors and clinical teams must navigate.

Lean authoring, a method popularized by medical writing expert Gregory Cuppan, emphasizes streamlined, focused writing that delivers key messages without unnecessary detail. It promises efficiency, but the reality of implementing lean authoring within a cross-functional team often involves substantial negotiation. Lean authoring becomes not a black-or-white process but, rather, an exercise in grayscale methodology.

<p>Deadlines to meet, projects to juggle, and dynamic demands? Work can be stressful at times. It’s no wonder people feel anxious and overwhelmed. Well, that’s when you might want to spend some time on a yoga mat! Physical and mental health are strongly related, and their relationship is well described in literature, too. Frequent stress&hellip;</p>

In today's ever-evolving work environment, shaped by the aftermath of the COVID-19 pandemic, the once-standard 9-to-5 office routine is rapidly becoming obsolete. This shift is ushering in the era of remote work, with various professions embracing change seamlessly. Among them, medical writing stands out as particularly well suited to adapting to this new way of working.

Establishing early alignment with the FDA on the rolling submission approach is pivotal to your success. Before you initiate any submission activities, ensure you have secured the FDA's agreement on both the timing and the scope of your rolling submission.

For a drug to get on the market in the United States, it must go through a rigorous review by the FDA's Center for Drug Evaluation and Research (CDER) (or, in some cases, the Center for Biologics Evaluation and Research [CBER]).