- Addressing the critical decision of whether to completely outsource or retain some aspects in-house
- Understanding the advantages and challenges of each approach
- Discussing strategies for efficiently managing multiple CRO partnerships
- Identifying ways to find a balance between cost and quality in outsourcing
- Exploring the range of services and expertise offered by different CROs
- Strategies for effective contract negotiations with CROs
- Understanding the value of building strong, long-term partnerships with CROs
- Overview of achievements and challenges for clinical research in the digitizing German landscape
- Potential and proven uses of digital health applications
- Pitfalls and how these can be mastered
- CRO remits in clinical investigations
- Is it possible to have efficient data collection from investigators and sites?
- Statistics fascinating transforming of collected data or boring evil necessity?
- Possibilities to assess reliability of collected and processed data
- Understanding statistical reports and issues with results interpretation
- EU MDR requirements on data in clinical investigations
- What is Real World Evidence (RWE) and what opportunities does it hold?
- How to select RWE that can withstand scrutiny?
- Important considerations when deciding what data to collect
- Tips on how to draw the right conclusions from RWE
- Understanding the benefits of working with CROs in medical device development
- Identifying common challenges faced while working with CROs
- Promoting open communication channels for effective problem-solving
- Defining clear roles and responsibilities to avoid overlap and confusion
- Identifying potential risks associated with collaboration and outsourcing
- Strategies for building long-term partnerships with CROs
- Understanding the importance of collecting real-world data for medical devices
- Sharing best practices and case studies on leveraging real-world data for device improvement
- Laying out a plan in early stages of what you can do post-market
- Understanding the significance of selecting appropriate trial endpoints for study success
- Addressing challenges faced by midsize and small companies in conducting large-scale trials
- Highlighting the need to consider alternative endpoints for trials with limited resources
- Identifying essential information needed to demonstrate device safety and performance
- Discussing the interplay between regulatory requirements, safety considerations, and product development goals
