The FDA Group's Nicholas Capman welcomes Keith Parent, CEO of Court Square Group and RegDocs365, to discuss practical approaches to implementing AI in clinical trials and regulatory operations. With 30 years of experience managing infrastructure for life science companies, Keith offers insights on how organizations can effectively adopt AI while maintaining compliance.
Discussion points include:
- Industry Adoption Patterns: Keith contrasts how large pharma companies are establishing AI centers of excellence for major cost-saving initiatives while smaller companies are experimenting with tools like ChatGPT. He emphasizes the importance of solutions that can scale from large to small organizations.
- Privacy and Compliance: The conversation explores critical considerations around using AI tools within company firewalls, protecting intellectual property, and the evolving attitudes of regulatory groups toward AI-generated documentation.
- Practical Applications: Keith details several real-world use cases, including (1) TMF auto-classification to reduce manual document processing time, (2) automated labeling information compilation from multiple systems, (3) regulatory correspondence analysis for identifying commitments, and (4) historical submission analysis to improve future applications.
- Implementation Strategy: Keith recommends starting with "low-hanging fruit" - manual processes that can be automated - rather than attempting large-scale projects initially. Keith stresses the importance of demonstrating success with smaller projects to build momentum.
- Human Oversight: Keith highlights the importance of maintaining "human-in-the-loop" verification for lower confidence AI decisions while using machine learning to improve system accuracy over time.
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The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations.
For project or resource needs, visit: thefdagroup.com.
Court Square Group is a managed service firm specializing in infrastructure management for life science companies, working with both large pharmaceutical companies and small biotech firms for about 30 years. Visit: courtsquaregroup.com
RegDocs365 is a specialized provider of regulatory solutions for the life sciences industry. Visit: regdocs365.com
