Archives: Agenda

• Operational Strain: Traditional, manual audit trail reviews across siloed clinical systems drain clinical operations resources, delay study close-out, and increase regulatory compliance risks.
• Unified Ingestion: Workflow automation continuously ingests disparate digital logs from EDC, eCOA, and IRT systems into a single, standardized operational layer.
• Intelligent Traceability: Autonomous AI agents map complex patient data journeys across the digital network, automatically flagging data anomalies and out-of-sequence transactions.
• Business Impact: Shifting from reactive sampling to automated, comprehensive oversight slashes inspection-readiness timelines, optimizes trial oversight, and guarantees ironclad data integrity.

There are many aspects to moving from early research to clinical delivery under one roof. This session explores the practical realities of building clinical operations and establishing an in-house Phase II unit.

• Building and scaling a clinical operations function
• Talent, structure, and service provider strategy
• Establishing an in-house Phase II unit: key considerations and patient recruitment

• A real-world case study demonstrating where AI has tangibly reduced costs or accelerated timelines
• How AI was implemented in practice (e.g. patient recruitment, data cleaning, site selection) and what made it successful
• Breaking down the ROI: cost savings, efficiency gains, and operational impact
• Lessons learned: where AI delivered value vs where it fell short—and how to replicate success in smaller biotech settings

• Meet the #1 AI CRO: Deep Intelligent Pharma Overview
• Industry Pain Points: High Clinical Development Failure
• DIP’s AI-Human Hybrid Approach to Clinical Development
• Real-World Success Stories & Proven Results