MDR Compliant Prospective & Retrospective Clinical Studies

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

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.

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. Especially 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

Solution

Nobel Biocare selected SMART-TRIAL EDC and SMART-TRIAL Cases as the solutions. This enabled all needed types of post-market studies in a single system with complete data traceability and security. Additionally, SMART-TRIAL’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 SMART-TRIAL 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

“We really needed an EDC with easy setup and fast buildup where everything can be done by yourself. That’s exactly what we got with the SMART-TRIAL platform. It helped us simplify our processes so much – especially because of the ability to duplicate study setups. It’s a very cost-effective solution and it helped us save a lot of internal resources." Florian Kübler, Senior Clinical Research Associate, Nobel Biocare.

Moving forward, Nobel Biocare will continue to run post-market clinical studies with SMART-TRIAL.

‍