The promise of AI-assisted writing in clinical documentation often evokes visions of blazing efficiency and seamless workflows. But beneath the surface lies a stubborn bottleneck that even the most sophisticated algorithms cannot erase: the manual handoffs between authors, reviewers, and disparate systems. This hidden friction point isn’t just a minor inconvenience; it is a systemic tax on time and quality that disrupts the very efficiencies AI aims to unlock and can lead to

The FDA’s latest innovation signals reveal how regulatory systems are evolving—and what FDA regulatory innovation may increasingly require from industry.

Azure-hosted AI platform revolutionizes clinical and regulatory writing with automation, traceability, and explainable AI.  Dedham, MA — November 21, 2025 — Synterex, Inc. , a global c onsulting firm specializing in clinical and regulatory operations, agile methodologies, and AI-driven technologies, has announced the availability of its flagship solution, AgileWriter.ai® , on the Microsoft Azure Marketplace. This launch expands access to Synterex’s AI-powered regulatory-writi

Machine learning is transforming clinical trial monitoring from slow, manual oversight into real-time, predictive decision-making. As decentralized designs, digital biomarkers, and regulatory expectations evolve, the industry is entering a new era where data integrity, responsiveness, and automation are no longer optional—they’re essential.

Understanding AI Technologies AI technologies have made significant strides in recent years. Generative AI, in particular, has changed how we approach various tasks. From content creation to data analysis, AI is becoming an indispensable tool. However, to maximize its potential, we must understand the nuances of its operation. The Importance of AI in Biotech and Pharma In the biotech and pharmaceutical sectors, AI can streamline processes, enhance accuracy, and improve compli

Learn how Synterex helps biotechs turn regulatory uncertainty into advantage through expert strategy, automation, and AI-enabled efficiency.

Generative AI is rapidly making its mark in professional writing, but a critical question remains: is it actually doing the work, or...

AI-enabled medical writing significantly streamlines the clinical documentation process, but common pitfalls can reduce its...

Once Upon a Prompt  In academic and clinical research, time is a precious commodity—and so is clarity. With artificial intelligence (AI) writing tools evolving at breakneck speed, researchers and medical writers are now asking a vital question:  How far can AI take us in crafting better, faster manuscripts?  The answer lies in the growing integration of AI-powered writing assistants and the complex terrain of ethics, journal policies, and return on investment (ROI).  Let’s lo

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. 

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.

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.

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.

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.

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

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.

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.

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.

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.