Archives: Agenda

• Exploring lessons from shifting between outsourcing models
• Supporting clearer expectations between sponsors and CROs
• Strengthening RBQM alignment across portfolios

• Exploring community-based research solutions — particularly mobile visits — beyond simple procedural support, toward a more holistic, human-centered approach
• Demonstrating how mobile research clinicians deliver far more than sample collection, bringing diverse skilled clinician types directly to patients’ homes and communities to perform complex protocol activities
• Highlighting how expanded clinical capability strengthens trust, enhances patient experience and drives high-quality data collection, reinforcing human presence as a key differentiator in an increasingly technology-driven research environment

• Understand when oversight creates real value versus when it’s just a checkbox
• Hear what vendors wish sponsors would stop doing (and vice versa)
• Explore 3 key pillars of oversight: relationship management, performance management, and quality & compliance
• Learn how industry leaders are navigating the hardest parts of risk-based oversight: scalability, regulatory complexity, and the resource-intensive nature of the work
• Walk away with practical insights you can apply to your own oversight plan — whether you’re building one from scratch or maturing an existing program

Moderator: Peter Haessig, Head of Client Partnerships, Diligent Pharma

• Defining clear roles between sponsors and vendors in hybrid models to avoid overlap
• Facilitating seamless exchange of operational metrics and risk indicators across vendors ensuring proactive oversight and responsive decisions
• Implementing risk-based oversight to focus on what matters most eliminating redundancies while enhancing quality
• Designing governance frameworks that accelerate decision making while ensuring continuous inspection readiness

• How well‑designed digital measures deliver measurable ROI in clinical trials by reducing missing data, improving statistical power, accelerating timelines, and preventing costly trial rework or failure
• How an end‑to‑end Wearable Sensor CRO delivery model integrates scientific strategy, operational oversight, and analytics to consistently produce regulatory‑ready datasets
• Real‑world case examples showing how proactive compliance monitoring and fit‑for‑purpose algorithms dramatically improve data completeness and statistical power
• The critical role of disease‑specific digital endpoint design versus off‑the‑shelf wearable algorithms in capturing meaningful treatment effects
• Practical guidance for clinical operations and outsourcing teams on reducing sponsor burden while scaling wearable technologies across global trials

• Demonstrating good faith compliance with emerging expectations
• Documenting rationale and regulatory intelligence in trial files
• Engaging with FDA proactively to validate regulatory strategy

• Why be a sponsor of choice in the ever changing landscape
• What we do to elevate our site partnerships
• Always keep pushing through curiosity to drive innovation to ensure the health of our industry