Archives: Agenda

• Partnering for Transformation – SOLTI chose Flex Databases to address the limitations of their previous CTMS and improve operational efficiency.
• Migration Process – The transition managed through structured planning, tailored configuration, and consistent communication between both teams.
• Operational Improvements – Enhanced reporting, adaptable dashboards, and better oversight of monitoring activities supported by a more intuitive system.
• Key Takeaways – SOLTI’s experience highlights how a well-managed migration can strengthen trial management and prepare organizations for future growth

•             Key steps and requirements for obtaining trial authorisation in the EU
•             Comparing regulatory frameworks and timelines across regions
•             Managing workload and compliance with limited resources
•             When and why to outsource submissions
•             Best practices and tips from experience for efficient submissions

• Managing communication across global teams and sites
• Dealing with logistical issues like shipping and storage
• Ensuring consistent data collection and trial processes across countries

• Leveraging data to inform early protocol design and feasibility
• Identifying optimal countries and investigator networks through data-led geographic analysis
• Benchmarking expected timelines, enrollment performance and cost parameters
• Enhancing site selection and feasibility assessment using integrated datasets and e-feasibility tools
• Applying real-time data monitoring to detect risks and inform mid-trial decision-making

• Unlock the Swiss potential – Switzerland’s strength and challenges in the clinical trial framework
• Transforming clinical trials in Switzerland – what can be learnt from others
• Navigate the future – how Switzerland embarks for a new era fit for the future

• Analyzing the efficiency and cost benefits of an all-in-one CRO versus using specialized CROs for different phases
• Evaluating the flexibility of a multi-CRO model in adapting to diverse project needs and expertise
• Weighing the risks of relying on a single provider versus the coordination challenges of managing multiple vendors
• Considering the impact on communication, data integration, and consistency when using a single CRO compared to multiple CROs
• Discussing the potential for innovation and quality improvements with specialized CROs versus the streamlined approach of an all-in-one model

Moderator

• Comparing in-house and outsourced models for clinical trial execution
• Evaluating decision-making frameworks for choosing the right resourcing strategy
• Identifying key benefits and trade-offs in quality, speed, and flexibility
• Exploring hybrid models and integrating CROs or FSPs effectively
• Adapting operational approaches based on trial complexity, indication, and geography