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Empowering Clinical and Regulatory Writing: Harnessing AI as Your Assistant

With nearly a million man-hours dedicated to AI research, GenInvo has been exploring the potential applications of AI in Clinical and Regulatory Writing by thoroughly evaluating its capabilities and limitations to understand whether it will complement or replace human efforts.

Insights and findings will be shared during this session which will explore the significant impact of AI on Clinical and Regulatory Writing, as well as its implications for various pharmaceutical functions. The presenters will showcase how GenInvo tools (DocWrightAI™, DocQC™, and Shadow™) leverage AI algorithms to automate the creation of regulatory deliverables. Additionally, they will discuss how a thoughtful integration of AI can enhance work-life balance and streamline task and deliverable management for medical writers.

Participants can expect to see examples of advancements in protocol and Clinical Study Report (CSR) development, narrative creation, and regulatory document quality checks—all accessible from a laptop or tablet. Highlights also include the use of machine learning (ML), natural language processing (NLP), and artificial intelligence (AI) for data, document, and image anonymization and redaction, ensuring the protection of both patient and company confidential information.

Additionally, real-time statistics on accuracy and time savings achieved through AI will be discussed. By the end of the webinar, participants will have thorough understanding of the current and future impact of AI on medical writing deliverables and how it can enable them to concentrate more on the scientific elements of their work.

Learning Objectives

After participating in this webinar, participants should be able to

• Identify the Optimal Balance between AI/automation and human input in Clinical and Regulatory Writing.
• Review Real-Time Statistics on AI accuracy and time savings, assessing their impact on efficiency.
• Understand the Impact of AI on Clinical and Regulatory Writing within clinical trials.
• Recognize Areas for Effective AI Application, including specific tasks and processes in Clinical and Regulatory Writing.
• Analyze the Successes and Challenges of AI in various authoring and content review scenarios, gaining insights into both its potential and limitations.

• Medical writers and Regulatory executives investigating the use of AI and automated tools to enhance workflow and content automation in Clinical and Regulatory Writing.
• Regulatory & Clinical Medical Writers with a focus on innovation and digitalization, ranging from intermediate to expert levels.

Abhijeet Arora is an experienced statistician and subject matter expert (SME) in statistics, with a focus on developing innovative tools using AI-driven systems. With over 10 years of experience as a Data Scientist, he has contributed to numerous projects in the Life Sciences domain.

Dr. Sheetal G. Bagul is the subject matter expert (SME) in DOC QC and Data Transparency at GenInvo. Dr. Bagul has several years of experience in the medical writing domain and had been involved in authoring and reviewing various regulatory documents. She provides inputs based on medical writing that can support/enhance building automation tools such as Artificial Intelligence (AI) and Machine Learning (ML) for drafting and review of clinical and regulatory documents.

Inderjeet Arora holds an MSc in Statistics and brings over 12 years of experience as a Statistician. Inderjeet began his career as a research fellow Statistician, exploring the intricacies of clinical trials and trial data. He then moved into a biostatistician role, where he gained experience in writing and reviewing statistical analysis plans (SAPs), sample size calculation, reviewing clinical and regulatory documents, generating and reviewing standard datasets and specifications, and producing tables, figures and listings (TFLs). He possesses extensive expertise in Clinical Data Management, Biometrics, and Clinical and Regulatory Writing, and is skilled in SAS, R, Python, and VBA. Inderjeet is an experienced subject matter expert (SME) and lead tool developer. His primary focus is on automating manual processes by incorporating AI-driven solutions into clinical trials.

Nalin Gupta has a wealth of experience spanning over two decades. Nalin is fueled by a passion for innovation and thrives in the face of challenges. His enthusiasm extends beyond the professional realm, manifesting in pursuits such as flying, racing, and embracing fun challenges. As a serial entrepreneur, he is a co-founder of several successful ventures including GCE Solutions, Adidev Ventures, GenInvo, and others. Throughout his career, Nalin has spearheaded groundbreaking initiatives in the pharmaceutical industry, contributing to global solutions and fostering strategic partnerships that drive efficiency and innovation.