| Ensuring the right medical monitoring (MM) approach is critical to trial success—but sponsors often overlook key factors that impact cost, efficiency, and patient safety. This session will cover three essential questions sponsors should ask: Who is on the medical team and do they have real-world expertise? Are you paying for the right level of MM or just paying more? When should MM start, and what happens if it’s too late? Attendees will gain actionable insights on how to optimize MM strategy, avoid unnecessary expenses, and enhance study outcomes.
· Medical monitoring teams: Why indication-specific expertise matters. · Cost versus value: Avoiding unnecessary 24/7 coverage and eligibility review costs. · Early MM involvement: How proactive planning prevents protocol pitfalls. |
Archives: Agenda
Advancing Clinical Programs for Rare Diseases
- Overview of Rare Diseases
- Global regulatory landscape for rare diseases
- Designing Clinical Programs for rare Diseases
- Overcoming Challenges in Rare Disease Trials
Technology Solutions for Reducing Hidden costs in Clinical Supply and Trial Changes
| Inefficiencies in investigational medicinal product (IMP) management can significantly impact trial timelines and budgets. We’ll explore strategies to optimize the clinical supply chain, focusing on advanced forecasting strategies to minimize waste without compromising patient access. Discover how to build a robust, long-term supply plan that enhances overall trial efficiency and ensures secure, cost-effective IMP delivery. |
Beyond Boundaries – Unlocking the Potential of Cross-Border Enrollment in Clinical Trials
Clinical trials are the backbone of medical innovation, but one of the biggest challenges we face is patient recruitment. In an era where diseases know no borders, why should access to potentially life-saving treatments be limited by geography? Cross-border enrollment offers a powerful solution—expanding trial access, accelerating recruitment, and improving diversity. But it’s not without challenges. This session will
- Give a background on cross border enrollment and why it is a beneficial tool in clinical trial recruitment
- Discuss some regulatory and logistical challenges when implementing cross border enrollment
- Provide case studies of Worldwide Clinical Trials successful implementation of cross border enrollment strategies
END OF CONFERENCE
Speaker Hosted Roundtables
Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.
Roundtable session lasts for 30 minutes and rotate
| ROUNDTABLE 1: Comparator Sourcing in Small Biotech: Overcoming Limits with Strategic Outsourcing |
| ROUNDTABLE 2: Driving Efficiency and Results Through Strong Sponsor, CRO Partnerships
YongGwan Kim, Associate Director, Janssen |
| ROUNDTABLE 3: Key Areas to Focus on for Proactive Inspection Preparedness in Today’s Regulatory Landscape |
| ROUNDTABLE 4: Integrating Packaging and Labeling with Clinical Supply Chain Operations |
Chairperson’s closing remarks
PANEL DISCUSSION: Turning Transit Troubles into Triumphs: Proven Strategies for Clinical Supply Success
- Common causes of transit issues: shipment delays, temperature excursions, customs holds, and packaging failures
- Addressing gaps in global regulatory guidance
- Practical solutions for streamlining supply chain processes
Lunch and networking
Prize Draw taking place in exhibition hall at 14:15
Join us for a chance to win one of our prizes, including Apple products
Why do clinical supply also require shipping validation
- Overview of recent changes in regional regulations.
- Supplier management
- Shipping validation case study