The SNIS PSO is partnering with the FDA and device manufacturers to use NVQI 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 data for multiple stakeholders is efficient. Sites that participate in these projects do not need to enter data twice.
Participation in the NVQI 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.
We combine 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 – is asking the same question: how do we reduce the time and cost to bring safe and effective therapies to market?
NVQI and M2S have the answer. We offer:
- 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.