Synterex Blog

The FDA’s recent Evaluation of Labeling Submissions with AI (ELSA) pilot program has generated both curiosity and skepticism in the regulatory community. Early responses from reviewers using ELSA have been mixed, with some finding it helpful for catching inconsistencies or typos, while others found it redundant or disconnected from their workflows. While the effort is laudable, the ELSA pilot highlights deeper limitations in how general-purpose AI tools perform in complex, re

Integrating technology-assisted content reuse into medical writing can reduce stress for writers by preventing unnecessary rework and maintaining consistent document quality and compliance. This ensures timely delivery of important new therapies to the patients who need them. 

AgileWriter™ is an AI tool designed specifically for medical writing, developed by experts in the field to meet the precise needs of clinical documentation. Importance of Subject Matter Experts: Involving subject matter experts (SMEs) in the creation of AI tools for medical writing ensures the tool is practical and meets user needs, avoiding misalignment and inefficiencies.

Pediatric drug development is one of the most challenging areas of regulatory writing, where precision, guidance interpretation, and strategic planning are crucial to achieving regulatory success. Medical writers play a pivotal role in ensuring that regulatory submissions are clear, compliant, and robust enough to meet the unique needs of pediatric populations.

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.

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.

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.

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.

Step into the dynamic world of medical writing at Synterex and discover a day in the life of our talented medical writer, Cheryl Kolus. 

When preparing regulatory submissions, especially in fields like oncology, it's crucial to focus on the end goal—the drug's label or Summary of Product Characteristics (SmPC). These documents aren’t just regulatory requirements; they serve as the foundation for how the drug will be positioned in the market.

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."

In the rapidly evolving landscape of artificial intelligence (AI), the 11 × 11 tipping point has emerged as a critical concept. This tipping point refers to the moment when AI technologies reach an optimal level of efficiency and effectiveness.

In recent years, the integration of Artificial Intelligence (AI) into various sectors has sparked widespread discourse, particularly concerning its application in the medical writing field.

Writing is often thought of as a solitary task. An author sits in a quiet, isolated environment, plugging away with their thoughts. With regulatory writing, this couldn’t be further from the truth. Instead, it’s often a chaotic mix of emailing colleagues, coordinating timelines, and managing input from stakeholders.

My idea of life at eighteen was very different than it is from life now at twenty-three. I think we’ve all been there: wanting to grow up, needing to be our own person, and dying for some independence.

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.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) recently released a third revision of its E6 Guideline, also known as ICH E6 (R3). This revision introduces new concepts and updates in the realm of clinical trial methodologies, with an emphasis on quality, flexibility, and modernization.

Last year I had the pleasure of participating in the Synterex Regulatory Writing and Medical Communications Fellowship. I worked with and learned from Synterex staff members across all areas of the business, including medical writing, project management, quality control (QC), publishing, and business operations.

We asked ChatGPT to tell us a story about a medical writer; here’s what it got right and what it got wrong.