Implementing Remote Monitoring - Save Costs and Meet Deadlines!
Risk-based monitoring including remote monitoring, is an approach that has been successfully applied now for many years. With increased requirements for conducting post-market clinical follow-up studies and registries, how can monitoring be optimized so you continue to ensure compliance and accuracy of data that will be accepted by the notified bodies or regulators while keeping costs reasonable?
Risk-based remote monitoring combined or not with onsite activities and a strong risk management structure, along with well-designed compliant tools can make the whole process much faster and reduce the amount of financial and human resources needed. Moreover, with the current restrictions implemented to contain the global COVID 19 pandemic, remote monitoring may well be the only solution to avoid a complete halt in research!
Here are a few important points that are worth considering:
- Optimize time spent on source document verification, device accountability and other monitoring tasks – use the previously required travel time to effectively monitor instead of travelling and save the travel costs.
- Work closely with hospital staff from the start of the study to establish which remote monitoring tools are feasible for the different monitoring tasks.
- Plan process wisely - i.e., more flexibility working on the different monitoring tasks remotely versus trying to do it all in one day while onsite.
- Target objective(s) of the PMCF – focussing on what you really need to know will reduce the costs along with moving as much as possible to remote monitoring.
- Among the many other practical tips that will be presented throughout the webinar, remote monitoring also contributes to safeguarding our planet – i.e., electronic documents vs paper and less travel!
- Overview of Remote Monitoring Tools / James Kahl, IBM Watson Health
- Implementing Remote Monitoring in Europe / Frank Maier, MD-Clinicals
- Implementing Remote Monitoring in Asia / Ivon Septriyana, MD-Clinicals