- Navigate new regulatory requirements and complex study designs with larger sample sizes and a broader global footprint
- Implement country and site selection strategies that optimize FPI/LPI milestones
- Manage the complexities of enrollment, cohort management, safety review, and trial logistics across multiple regions
- Maintain a patient-centric approach to optimize study coordination and to benefit patients
- Oncology trials are growing in complexity, both in design and execution.
- Precision medicine is leading to hyper-fractionated patient populations in biomarker-driven studies.
- Sponsors and CROs must evolve their operating models to enhance patient centricity in this shifting landscape.
- This session presents a 360° Site Support model that puts patients at the center — with proven success in oncology trials.
- Chronicles of a site whisperer: Unlocking underperforming trials through connection
- Front-loading focus: Proactive engagement for study success
- Partnership greenhouse: Cultivating strong site relationships
- Safety net navigator: Why escalation pathways matter
- Defining what do we do well and what could be improved – EU vs US focus
- Planning and preparation within oncology drug trials – focus on phase 2/3
- Choosing the right trial designs for rare disease studies
- How to achieve a successful launch by building appropriate phase 3
- Navigating new regulations around clinical trials smoothly and successfully
- Predictions for how the global markets will impact US studies
- The impact of artificial intelligence: how far can we expect to move forward in the next 12 months?
- Patient centricity in clinical trials: how can burden be reduced in order to make trials easier for patients to participate in?
- Understanding how we got here
- Coordinating JCA in parallel to MAA
- How to adapt your oncology strategy to JCA
- What’s next for JCA
