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...

Discover actionable frameworks to incorporate the patient voice throughout clinical trials and ensure study design delivers both regulatory value and real-world outcomes.

Guest: Lisa Lea – Director of Patient Insights, Merck

LinkedIn: Lisa Lea

With over 20 years in biotech and clinical development – 18 of those in pulmonary arterial hypertension – Lisa leads global strategies to embed patient perspectives into every phase of research at Merck.

Clinical trial success increasingly depends on moving beyond tokenistic patient engagement towards approaches that deliver measurable value. Recorded live at COG Bay Area, this session features Lisa Lea, Director of Patient Insights at Merck, as she shares operational frameworks and firsthand experiences for integrating patient perspectives early and often throughout study development.

Lisa draws on decades of clinical and industry leadership to clarify what meaningful patient engagement really looks like, why regulators and payers now expect it, and how study teams can systematise input to improve trial design, recruitment, and data integrity. Real-world vignettes underline how adapting protocols – even small adjustments – can avert site and patient loss, while strategic engagement with advocacy groups transforms both design and recruitment outcomes.

Key themes include trends in regulatory expectations, practical avenues to gather patient feedback, and tools to quantify the impact of engagement. Whether you oversee protocol development, feasibility, or operations, you’ll come away with a concrete checklist to embed patient insight across study endpoints and execution.

00:03:09 – “Nothing about us, without us”: Why early patient involvement sets the foundation for relevance, retention, and success in clinical trials.

00:04:49 – 80% of clinical trials miss recruitment goals, with preventable patient burden as a key factor – the case for patient-driven protocol design.

00:05:58 – The evolution of patient engagement post-HIV/AIDS activism and how regulatory expectations have transformed over the past three decades.

00:07:03 – Practical definition of patient-focused drug development and the FDA’s systematic approaches for capturing patient and caregiver input.

00:08:00 – Concrete benefits: Patient engagement improves recruitment speed, retention, data relevance, diversity, and streamlines protocol amendments.

00:10:42 – How and where to embed patient voice, from prioritizing advocacy partnerships to pragmatic steps during protocol development and feasibility assessments.

00:12:43 – Examples from site operations: The operational consequences of burdensome visit schedules and how patient input can safeguard enrollment.

00:15:40 – “Beyond tokenism”: Strategies for feedback loops that demonstrate value to patients and foster true partnership.

00:17:01 – Common operational challenges – cultural resistance, lack of structure, and compliance concerns – and proven solutions to address them.

1. Engage patients early and often – feedback at protocol development and feasibility planning stages is critical to avoid costly amendments and study delays.
2. Use advocacy partnerships, patient advisory boards, and real-world data sources to identify barriers and needs that might otherwise be overlooked.
3. Create clear, structured feedback loops and share outcomes so patients see how their input drives tangible improvements in studies.

Discover practical strategies for building cross-functional alignment and trust to ensure faster, more efficient completion of clinical trials.

Featuring: Kimberly Guedes, VP Clinical Operations, Intensity Therapeutics (LinkedIn), keynote speaker at COG Bay Area

Recorded live at COG Bay Area, this episode delivers a candid, operationally focused keynote from Kimberly Guedes, drawing on over 30 years in drug development, global clinical operations, and vendor oversight. David Jones guides the conversation, foregrounding challenges and solutions for anyone directing clinical study delivery in pharma, biotech, or contract research settings.

The discussion homes in on one of the biggest practical challenges for clinical leaders: how to foster true stakeholder engagement across sponsors, CROs, sites, vendors, and trial participants. Kimberly Guedes shares grounded advice for aligning incentives, clarifying roles, and maintaining continuity even when teams and vendors change throughout a study’s lifecycle. Several specific pain points are unpacked, from failures in upfront communication to the morale impacts of frequent rework, with actionable steps for improving transparency, collaboration, and operational efficiency.

00:02:23 – Defining stakeholder engagement: why it matters for timelines and data quality.

00:04:56 – The risk of mismatched priorities: sponsors, CROs, vendors, and site perspectives.

00:05:40 – How honest, early communication reduces uncertainty and costly rework.

00:06:54 – Downside of poor engagement: delays, low morale, and repeated mistakes.

00:08:08 – Laying the groundwork: best practices for planning, joint training, and truly collaborative kick-off meetings.

00:10:03 – Building mutual respect: recognising expertise and encouraging transparent conversations.

00:12:07 – Establishing clear governance and efficient escalation paths for faster decisions.

00:13:43 – Keeping roles and responsibilities up to date as teams change.

00:17:38 – The power of inclusivity: making every partner and participant feel ownership of the project.

00:18:16 – Active listening and seeking out what isn’t being said – practical tips for better meetings, both remote and in-person.

00:24:23 – Top reasons for trial delays: lack of key conversations up front, underestimating contracting and operational constraints, and not integrating practical site or CRO input before protocol finalisation.

• Initiate honest conversations early with all operational partners – from contracting and CROs to sites – to surface constraints and align expectations before finalizing protocols and timelines.
• Prioritize continuity and regular communication, especially when teams change, through real-time updates of responsibilities and direct outreach beyond the project core.
• Foster an environment of active listening, transparency, and personal connection – even in remote or hybrid teams. Clarity, engagement, and recognition of expertise drive better outcomes.

Intensity Therapeutics

Kimberly Guedes on LinkedIn

“If you don’t know the constraints of your partners, the timelines that they can do things in, then you have failed already.”

“We build more predictability on outcomes if we have honest conversations—even if those conversations are uncomfortable.”

“Have clear roles and responsibilities. Make sure to update stakeholders as new team members are added...