Posts Tagged ‘regulatory writing’
Bridging Innovation and Compliance: Aligning Digital Transformation with the EU AI Act
Digital transformation in the biopharma industry isn’t just about adopting the latest technologies—it’s about fundamentally reimagining how clinical trials are designed, conducted, and analyzed. This shift involves integrating artificial intelligence (AI), cloud computing, and data analytics to streamline operations, accelerate drug development, and improve patient experiences. However, with the introduction of the European Union’s Artificial…
Read MoreThe New Frontier of Lean Authoring: Human-Centered Design in Regulatory Writing
In the evolving landscape of regulatory writing, it has become clear that creating clear and compliant documents is no longer enough. Building off the principles of lean authoring, regulatory writers must now consider holistically the experience of those who will review the documents. This is where human-centered design (HCD) principles, traditionally used in product and…
Read MoreWhy Subject Matter Experts Are Essential in Creating AI-Enabled Medical Writing Tools
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. Consequences of Excluding SMEs: Without direct input from medical writers, AI tools may focus on flashy features rather than essential functions, leading to misaligned priorities, extra user steps, and lost productivity. Benefits of AgileWriter™ are developed by medical writing leaders, integrates seamlessly into workflows, reducing guesswork and enhancing writing efficiency.
Read MoreThe Critical Role of Medical Writers in Pediatric Drug Development
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 this blog, we’ll…
Read MoreNavigating Medication Jenga: The Challenge of Polypharmacy in Geriatric Patients
As we age, the complexity of our health often increases, leading to the management of multiple chronic conditions. This reality gives rise to a phenomenon known as polypharmacy, or the simultaneous use of multiple medications in a single patient. Polypharmacy is a significant concern, particularly among geriatric patients, where it is sometimes referred to more…
Read MoreInsulin: The Savior of Millions
According to the National Diabetes Statistics Report,1 5.7% of all United States (US) adults with type 1 diabetes rely on insulin for managing their condition. Additionally, approximately 12.3% of US adults starting using insulin within a year of their diabetes diagnosis. Insulin stands as a cornerstone in the treatment regimen, offering hope and vitality to…
Read MoreBug Busters: Creative Combat Against Drug-Resistant Infections
In the ever-evolving battle against infectious diseases, the rise of drug-resistant infections poses a significant challenge to global health. These resilient bugs have developed mechanisms to withstand conventional treatments, leaving scientists and healthcare professionals searching for innovative solutions. In this blog post, we will explore the world of bug busters—the creative strategies, and the minds…
Read MoreArtificial Intelligence (AI): Accelerating Cancer Immunotherapy
Artificial Intelligence (AI) is revolutionizing the field of cancer immunotherapy by accelerating the discovery, development, and delivery of innovative treatments. Here is a breakdown of its potential role: Drug Discovery: AI algorithms can analyze vast amounts of genomic, proteomic, and clinical data to identify potential drug targets and predict the efficacy of immunotherapies. By leveraging…
Read MoreThe 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 MoreHow AgileWriter Addresses Common AI Concerns
In the rapidly evolving landscape of artificial intelligence, ensuring that generative AI systems adhere to robust standards is crucial. The National Institute of Standards and Technology (NIST), for example, has developed the Generative AI Intelligence Profile, a comprehensive framework designed to guide the development and deployment of generative AI technologies. AgileWriter is at the forefront…
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