Biotechnology

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

By pwsadmin / December 6, 2024 / Comments Off on 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.

Read More
Regulations in Blue Color on a White Background

ICH E6 (R3): Implications of Recent Updates for Medical Writers

By Alex Olinger / June 8, 2023 / Comments Off on ICH E6 (R3): Implications of Recent Updates for Medical Writers

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) recently released a third revision of its E6 Guideline, also known as ICH E6 (R3). This revision introduces new concepts and updates in the realm of clinical trial methodologies, with an emphasis on quality, flexibility, and modernization. Let’s explore the key updates and discuss how they might affect medical writers.

Read More