MDR Compliant Prospective & Retrospective Clinical Studies

The dental implant manufacturer, Nobel Biocare, continuously strives to deliver state-of-the-art implant-based dental restorations to professionals to ensure a better quality of life for patients worldwide.

As one of the market leaders, Nobel Biocare must always stay at the very forefront of innovation to maintain its position. And with innovation being a core part of the Nobel Biocare culture, clinical activities must run smoothly and efficiently with minimal resource waste.

Nobel Biocare manages clinical activities internally, and with the demands of the EU MDR, the need for post-market studies is significantly increasing. Therefore, Nobel Biocare must run both prospective and retrospective studies to ensure MDR compliance.

The Challenge:

Clinical studies to collect post-market data required a lot of work and internal resources with Nobel Biocare’s former data collection setup.

In the past, simple clinical studies like these were conducted in Excel sheet templates, which was extremely time-consuming. Data management required a lot of work and the process would not have been regulatory compliant with the implementation of MDR.

For the upcoming trials, Nobel Biocare needed to ensure:

• A simple yet 100% technical and regulatory-proof system
• Easy study setup
• Complete traceability
• State-of-the-art data security
• All data in one place
• Flexible export options

The Solution:

Nobel Biocare selected Greenlight Guru's EDC and Cases software as the solutions. This enabled all needed types of post-market studies in a single system with complete data traceability and security. Additionally, Greenlight Guru's eCRF software allows duplication of study setups, which made it easy for Nobel Biocare to copy-paste study setups from product to product.

Results:

Replacing Excel spreadsheets with the Greenlight Guru's EDC platform facilitated Nobel Biocare’s challenges regarding data collection and management. Compared to the former solution, the three main improvements were:

• Vast reduction in time spent on data management and study setup
• Less worrying about data security
• Simplified collection of MDR-compliant post-market data

Nobel Biocare will continue to run post-market clinical studies with Greenlight Guru Clinical.