Medical Imaging plays a significant role in the conduct of clinical trials and bringing new therapies to market. However, as application of medical imaging in clinical studies grow, so does the complexity of regulations on a trial’s conduct. The more sites, patients and modalities in a trial, the more complex the regulatory and workflow compliance.
Join this webinar to understand why and what regulatory elements should be considered even before you design your protocol and how this early adoption can lead to shorter, more successful clinical trials and smoother agency submission. Provided case studies will highlight benefits of having expert regulatory guidance, use of compliant processes mirroring FDA guidance and imaging standardization. Imaging charters, more complex Phase 3 and retrospective study considerations will be discussed.
Download our live recording to learn more about:
- Insight into current regulatory guidance
- Best practices into modality and anatomy selection
- Critical regulatory considerations to avoid potential study delays
- Compliance strategies for smoother submissions
- Insights into the Imaging Audit Approach