AI Integration in Clinical Outsourcing: Real-World Applications and Next Steps

Discover actionable guidance for integrating AI into clinical trial outsourcing, with a focus on operational efficiency, quality, and oversight from an experienced biotech leader.

Featuring:

Paulius Ojeras, Head of Clinical Operations, Perceive Biotherapeutics (LinkedIn), keynote speaker at COG Bay Area

Recorded live at COG Bay Area, this session features an in-depth presentation from Paulius Ojeras, who brings more than 18 years directing clinical programs in biotech and CRO environments. With a candid, technical perspective, he explores the evolving adoption of AI agents and automation in clinical operations - cutting through industry hype to share what’s working, where the risks lie, and how to implement with minimal disruption.

Paulius Ojeras addresses the practical realities of AI adoption, from early-stage automation through to “agentic AI” capable of acting as operational teammates. He details the case study of deploying AI for Trial Master File (TMF) management at Perceive Biotherapeutics, outlining the specific gains in error reduction, scalability, and process speed. The discussion goes beyond technology, offering a framework for selecting solutions, evaluating vendors, and anchoring AI initiatives in robust human oversight and process redesign.

This episode is tailored for clinical operations leaders, vendor managers, and outsourcing strategists seeking a best-practice, risk-mitigated approach to AI - filled with hard-won lessons, practical questions for suppliers, and clear indicators of what “good” looks like in this emerging space.

00:02:37 – The ‘AIQ’ (Augmented Intelligence Coefficient): Why most clinical operations teams score near zero today - and what that means for competitive advantage.

00:04:53 – The five levels of AI in clinical trials: From basic automation to fully autonomous agents.

00:06:28 – “Agentic AI” explained: Where AI can become a real teammate, not just a tool, and which activities are best suited for this shift.

00:09:51 – A live case study: How Perceive Biotherapeutics integrated AI teammates into TMF management, what triggered the decision, and how results compared with traditional CRO models.

00:13:02 – AI vs. human performance: How AI reduced TMF filing errors by 25% compared to QC-checked human work, with clear examples of operational improvements.

00:15:10 – Real-time quality by design: Automated document reconciliation, instant issue flagging, and the move away from labor-intensive QC.

00:18:06 – Key vendor selection criteria: Questions to ask, red flags to watch for, and why 95% of AI companies may not survive.

00:21:26 – Consistency, transparency, and validation: Guardrails for ensuring reliability and compliance in regulated trial environments.

00:25:05 – Change management and team education: Why AI literacy, prompt engineering, and cross-functional buy-in matter for sustainable implementation.

00:26:47 – The end game: How AI should amplify - not complicate - operations, freeing teams to focus on patient and protocol quality.

1. Think beyond automation - strategically redesign processes for “agentic” AI, ensuring humans focus on oversight and exception handling, not repetitive tasks.
2. Assess vendors the way you’d assess a new CRO: demand proof of real deployment, robust oversight, and clear accountability, not just a slick demo.
3. Invest in AI literacy across your team - garbage in means garbage out, so prompt design and...