Unique Needs for Medical Device Clinical Trials
AG Mednet’s Brian Kelly joins experts from Oracle to address data quality and compliance in medical device trials during this upcoming webcast.
The webcast – Adaptive Medical Device Trials for Fast, Seamless and Accurate Research – takes place Thursday, January 25, 2018, noon EST.
Medical device studies are complex and unique, with evolving regulatory oversight and compliance requirements. Mid-study changes are frequent and common. The ability to perform mid-study protocol changes and amendments without study disruption and migration, and the ability to contain costs within sponsor requirements, is critical.
When it comes to clinical trials, researchers and outsourcers have the same goals – speed, efficiency and flexibility. But how can you impact these variables today, for the specific needs of medical device studies?
Adaptive design and site-centricity hold the key. This session will focus on a case study of a medical device trial, and will discuss the insights and outcomes of the trial based upon real-time results shared with CRO and the sponsor as the study was being conducted. This case study allowed all parties to be aware of study progress with the flow of information on key research points and scores for medical device key indicators, resulting in 100 percent compliance with the evaluator training requirements in the study and subsequently a 100 percent error-free assessment rate.
With increased complexity in diagnostic and device trials, rapid data collection is not enough. Is your data inconsistent? Does your data from multiple sources introduce risk? Are you prepared for dramatic regulatory and compliance reforms?
If you face these concerns, this webcast will deliver a practical blueprint for how technology can be used to increase quality and reduce risk related to clinical data.
Speakers will address:
- How to develop a quality transparency and flexibility plan to share key KPIs with all stakeholders
- How to leverage expert oversight and management in critical areas to avoid hidden costs in conducting clinical trials
- How to develop a medical device trial’s study design for compliant EU MDR regulatory reforms