Archive for September 2024
The Curb-Cut Effect and AI-Driven Medical Writing: Accessibility by Design
The curb-cut effect refers to the broad and often unexpected benefits of designing for accessibility. Originally intended to assist people with physical disabilities, curb cuts have since proven beneficial for many others—parents with strollers, delivery workers with carts, and even travelers with rolling luggage. This concept extends beyond physical infrastructure to digital tools, including technology-enabled…
Read MoreThe Challenges and Benefits of Implementing e-Consent in Clinical Trials
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. Below, we’ll explore both the benefits and challenges of…
Read MoreThe Flip Side of Lean Authoring: Navigating the Complexities of Cross-Functional Negotiation
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. This…
Read MoreProject Deadlines, Dynamic Demands, Work-Stress! YOGA to the Rescue
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…
Read MoreRemote Rx: Writing from Home – Perks & Challenges
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…
Read MoreKey Considerations for Submitting Your NDA or BLA to FDA on a Rolling Basis
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. This early communication ensures that there are no surprises later and allows both you and…
Read MoreChronicles of Drug Development and FDA: Review, Approve, Monitor
For a drug to get on the market in the United States, it must go through a rigorous review by FDA’s Center for Drug Evaluation and Research (CDER) (or, in some cases, the Center for Biologics Evaluation and Research [CBER]). Drugs are tested in preclinical and then in clinical settings to assess safety and efficacy.…
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