The SNIS PSO is partnering with the FDA and device manufacturers to use NVQI-QOD to help meet device regulatory requirements. The quality of these devices is critical for neurovascular healthcare, so this is an important aspect of the SNIS PSO. Using NVQI-QOD data for multiple stakeholders is efficient. Sites that participate in these projects do not need to enter data twice.
Participation in the NVQI-QOD is required to participate in these projects. Because these are quality improvement projects in the SNIS PSO, and are surveillance of standard clinical practice with FDA approved devices, these studies would not require IRB approval or informed consent.
NVQI-QOD combines powerful data with cost-effective and experienced project management to help lower costs, reduce administrative tasks and shorten development lead times.
Everyone – from the device companies, to the FDA, to insurers – seeks the same goal: reduce the time and cost of bringing safe and effective therapies to market.
NVQI-QOD and M2S have the answer. This registry offers:
- Better retrospective and prospective registry data and imaging in pre-market stages to help create a more effective process for R&D and marketing.
- Better data and imaging combined with cost-effective management in clinical trials to help streamline process manage trial costs
- Better prospective, registry-based data in post-approval to accelerate the site and patient recruitment, while minimizing site administration
At every stage, access to better data sooner can make the difference for patients.