Technology Blog Posts

Building a Compliant Quality Management System for AI in Healthcare

By Jeanette Towles / January 16, 2025 / Comments Off

In healthcare and biopharma, ensuring patient safety, product quality, and regulatory compliance has always been paramount. A Quality Management System (QMS) serves as the backbone for these priorities, providing a structured framework for risk management, process standardization, and continuous improvement. As artificial intelligence (AI) becomes more embedded in clinical operations and drug development, traditional QMS…

Bridging Innovation and Compliance: Aligning Digital Transformation with the EU AI Act

By Jeanette Towles / January 16, 2025 / Comments Off

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…

The New Frontier of Lean Authoring: Human-Centered Design in Regulatory Writing

By Jeanette Towles / December 16, 2024 / Comments Off

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…

The Crucial Role of Accessibility in Medical Writing Authoring Tools: Building Inclusivity from the Design Phase

By Jeanette Towles / December 9, 2024 / Comments Off

In the race to bring software solutions to market, many software vendors face the challenge of balancing functionality, speed, and user experience. Often, accessibility can become an afterthought—not by intention, but due to the fast-paced nature of development. However, ensuring that authoring tools are accessible from the start offers immense benefits for all users, especially…

Why Subject Matter Experts Are Essential in Creating AI-Enabled Medical Writing Tools

By Jeanette Towles / December 6, 2024 / Comments Off

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.

Artificial Intelligence (AI): Accelerating Cancer Immunotherapy

By Jeanette Towles / October 24, 2024 / Comments Off

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…

The Curb-Cut Effect and AI-Driven Medical Writing: Accessibility by Design

By Jeanette Towles / September 30, 2024 / Comments Off

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…

How AgileWriter Addresses Common AI Concerns

By Jeanette Towles / August 10, 2024 / Comments Off

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…

Harnessing AI for Clinical Documentation in the Biopharma Value Chain: The Benefits of a Technology-Agnostic Approach

By Alex Olinger / August 7, 2024 / Comments Off

In the fast-evolving biopharmaceutical industry, the integration of artificial intelligence (AI) into clinical documentation processes presents an unprecedented opportunity to enhance efficiency and accuracy across the entire value chain. By adopting a technology-agnostic AI system, biopharma companies can significantly streamline operations, reduce costs, and accelerate drug development, ultimately delivering innovative therapies to patients more quickly.…

Unlocking the Power of Explainable AI in Content Creation

By Jeanette Towles / August 4, 2024 / Comments Off

As artificial intelligence (AI) permeates various aspects of life and business, the importance of explainable AI (XAI) grows, particularly in content creation tools—especially when those are being used in a regulated environment. Explainable AI enhances user trust by making the workings of AI systems transparent and comprehensible. This blog post explores the pivotal role of…