Unlocking the Power of Zero-Shot and Few-Shot Learning in AI-Enabled Medical Writing

Artificial intelligence has transformed technology-enabled medical writing, making complex documentation tasks faster and more efficient. But one of the lesser-known capabilities driving this revolution is zero-shot and few-shot learning—techniques that allow AI models to interpret, categorize, and apply information with minimal or no prior examples. At Synterex, our AI-driven solution, AgileWriter.ai, leverages these advanced learning…

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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The U.S. Food and Drug Administration’s (FDA) draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, offers a comprehensive framework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…

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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. 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.

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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. AgileWriter is at the forefront…

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Developing and Maintaining Metrics for Clinical Documentation Production and Understanding ROI in Artificial Intelligence (AI) Tools

Clinical documentation is a critical component in the healthcare and pharmaceutical industries, serving as the backbone for clinical studies, regulatory submissions, and patient care. Developing and maintaining metrics for the production of clinical documentation is essential to ensure quality, compliance, and efficiency and to be able to identify and mitigate risk during this process. When…

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Spotting the Hyperbole: Why AI Can’t Replace Medical Writers

In recent years, the integration of Artificial Intelligence (AI) into various sectors has sparked widespread discourse, particularly concerning its application in the medical writing field. With numerous claims suggesting that AI could potentially replace medical writers or drastically reduce the time taken to prepare regulatory documents, it’s crucial to address these assertions with a balanced…

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