Synterex Blog

In today’s fast-evolving digital landscape, digital employee experience (DEx) is more than just a buzzword—it’s an essential aspect of organizational success, particularly for professionals like medical writers.

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.

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]).

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.

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.

In the realm of medical writing, titles like "regulatory" or "pharma" may take center stage, overshadowing the less emphasized term "ethical medical writer."

We’ve all seen a lot of articles in the last few years about the pros and cons of the remote work environment.

Many side effects can result from poor posture: shoulder, neck and back pain, circulation issues, dizziness and even depression, to name a few. 

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. 

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.

National Entrepreneurship Day is a celebration of innovation, determination, and the pursuit of the American dream. It's a day to honor the entrepreneurs who have dared to dream big, take risks, and build businesses that not only benefit themselves but also contribute to the growth of our economy.

In the ever-evolving landscape of clinical trials, where the stakes are high and the demands are relentless, the value of mentorship and apprenticeship cannot be overstated. Many of us have been fortunate enough to have incredible mentors who guided us through our journey in the industry.