Thought leadership

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…

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…

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.…

Managing information requests from health authorities such as the FDA is a critical aspect of regulatory compliance for pharmaceutical companies. These interactions can directly affect the pace of your product’s approval process. To succeed, it’s important to follow best practices that focus on clarity, accuracy, and efficient project management. A key component to success is…

As Americans, we tend to be very insular in our thinking. Since we don’t generally need to know another language, most of us don’t understand anything but English. Since we typically have far fewer vacation days than other countries, our vacations tend to be short. Our travels are likely to be something like a week…

In the realm of medical writing, titles like “regulatory” or “pharma” may take center stage, overshadowing the less emphasized term “ethical medical writer.” This isn’t a downplaying of significance but a recognition that ethical considerations are the cornerstone of every medical writer’s practice. Ethical conduct is an unspoken yet powerful expectation and obligation. Each medical…

Pronoun conversations are popping up all over; and, luckily, they’re spreading to the workplace, too. As pronouns are deeply personal, it’s important that this part of a person’s identity is both respected and accepted at work.  To start any new work (or personal) relationship off on the right foot, introduce yourself with your name and…

By Katelyn Rivas Medical writers are experts at writing detailed scientific documents geared toward scientists, clinicians, and regulatory agencies. However, sometimes we are asked to prepare documents for a lay audience. These can include lay summaries of clinical study reports, informed consent forms, or other patient education materials. Given the complexity of the information, summarizing…