Technology Blog Posts

Good Machine Learning Practices (GMLP): Extending GxP Principles in AI-Enabled Healthcare

By Jeanette Towles / January 21, 2025 /

The integration of artificial intelligence (AI) and machine learning (ML) in healthcare has transformed how medical technology is developed, evaluated, and deployed. This innovation calls for adherence to rigorous quality standards to ensure safety, efficacy, and compliance. While traditional Good Practice (GxP) guidelines—such as Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory…

Designing an Audit Trail for AI in Clinical Trials: Aligning with the EU AI Act

By Jeanette Towles / January 21, 2025 /

As artificial intelligence (AI) continues to transform clinical trials, ensuring transparency, accountability, and compliance has become critical. Central to achieving these goals is the implementation of a robust audit trail system. While the EU Artificial Intelligence Act (EU AI Act) does not explicitly define audit trail requirements for high-risk AI systems, it emphasizes the need…

Engaging with the FDA on AI in Clinical Trials: Beyond Traditional Meetings

By Jeanette Towles / January 17, 2025 /

The U.S. Food and Drug Administration’s (FDA) draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, offers a comprehensive framework for the integration of artificial intelligence (AI) in drug development. For regulatory professionals, understanding the various engagement options beyond traditional FDA meetings is crucial for effectively…

Who’s Afraid of the Big, Bad EU AI Act?

By Jeanette Towles / January 17, 2025 /

The European Union’s Artificial Intelligence Act (EU AI Act) has become a significant milestone in the global regulation of artificial intelligence. As the world’s first comprehensive AI regulation, it introduces a risk-based framework designed to ensure the safe and ethical deployment of AI technologies. For industries relying heavily on innovation, like biopharma clinical trials, understanding…

Data Governance Under the EU AI Act: From Clinical Trial Analytics to Compliance

By Jeanette Towles / January 17, 2025 /

In clinical trials and healthcare, data comprise the foundation of every decision, from designing study protocols to analyzing patient outcomes. As artificial intelligence (AI) increasingly shapes clinical operations, data governance has become a critical factor in ensuring data quality, compliance, and ethical AI deployment. Data governance involves the management of data availability, usability, integrity, and…

Building a Compliant Quality Management System for AI in Healthcare

By Jeanette Towles / January 16, 2025 /

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 /

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.