Archives: Agenda

• Baselining the magnitude of China Biotech & Pharma
• Understanding the shift for the broader industry
• Reflecting on China market realities
• Implications for agencies, contractors, and vendors
• The way out

• Exploring how regulatory and economic shifts disrupt timelines
• Supporting teams to adapt while protecting patient access
• Strengthening readiness for rapid pivots in study delivery

Moderator:

Mary MacDonald, Director, Clinical Quality Assurance, Eisai

• 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

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

• 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

• 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

• 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