top of page

Synterex Blog
Search


Why ELSA Is a Step—but Not the Destination—for AI in Regulatory Writing
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

Jeanette Towles
5 days ago


Reducing Redundancy: How Structured Content and AI Reduce Rework in Medical Writing
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.

Katelyn Rivas
Jun 5


AI in Safety Narratives: Streamlining Data Interpretation
Safety narratives serve as a critical component of clinical trial documentation, providing a comprehensive account of a patient’s...
Salimata Ndir
May 19


Ethical Considerations in Automating Medical Writing Workflows
The advent of AI has brought with it many ethical concerns from medical writers and other stakeholders.

Elizabeth Patterson
Apr 8


Evaluating Your Medical Writing Department Menu of Services in the Age of AI
Instead of focusing on shrinking teams, medical writing leaders should use AI to expand their department’s scope and strategic value.

Jeanette Towles
Mar 18


Staff Retention: The Hidden KPI for Adoption of AI-Enabled Medical Writing
When implemented thoughtfully, AI can enhance job satisfaction, improve digital employee experience (DEx), and foster a great workplace culture.

Jeanette Towles
Mar 18


Unlocking the Power of Zero-Shot and Few-Shot Learning in AI-Enabled Medical Writing
Zero-shot and few-shot learning are techniques that allow AI models to interpret, categorize, and apply information with minimal or no prior examples.

Jeanette Towles
Feb 4


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

Jeanette Towles
Jan 21


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

Jeanette Towles
Jan 21


Engaging with the FDA on AI in Clinical Trials: Beyond Traditional Meetings
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 navigating AI applications in clinical trials.

Jeanette Towles
Jan 17


Who's Afraid of the Big, Bad EU AI Act?
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 this regulation is crucial.

Jeanette Towles
Jan 17


Data Governance Under the EU AI Act: From Clinical Trial Analytics to Compliance
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
Synterex
Jan 17
Building a Compliant Quality Management System for AI in Healthcare
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.

Jeanette Towles
Jan 16
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.

Jeanette Towles
Jan 16
The 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.

Jeanette Towles
Dec 16, 2024
The Crucial Role of Accessibility in Medical Writing Authoring Tools: Building Inclusivity from the Design Phase
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.

Jeanette Towles
Dec 9, 2024
Why 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.

Jeanette Towles
Dec 6, 2024
Artificial 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.

Jeanette Towles
Oct 24, 2024
The 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.

Jeanette Towles
Sep 30, 2024
How 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.

Jeanette Towles
Aug 10, 2024
bottom of page