In a groundbreaking development for dental clinical research, medical device company Solventum has implemented an innovative approach to clinical trial randomization by treating individual teeth as study subjects, utilizing Zelta by Merative's cloud-based eClinical platform.
Novel Trial Design Methodology
The revolutionary approach allows for the enrollment of individual teeth as study subjects, with participants able to contribute up to five teeth over multiple visits. This unique design addresses specific challenges in dental research while maintaining rigorous scientific standards. The methodology includes a sophisticated randomization model that pairs teeth of similar sizes, effectively reducing selection bias in the study.
Streamlined Data Management Process
Krista Dahling, Supervisor of Clinical Data Management for Solventum, emphasized the importance of efficiency in their fast-moving in-house clinical studies. "Our in-house clinical studies move very fast," she explained. "These studies are testing new concepts from the development team and they want answers fast. So, we are continually looking for new efficiencies in our trials."
The implementation leverages Zelta's Electronic Data Capture (EDC) platform capabilities to:
- Link teeth to specific subject IDs, preventing duplicate data entry
- Support customized trial models for precise research needs
- Import existing clinical libraries to accelerate study setup
- Create efficient data entry screens that reduce errors
Operational Impact and Efficiency Gains
Solventum, which manages approximately 45 clinical studies globally, has seen significant improvements in their research operations. Two-thirds of these studies are conducted in healthcare and dental facilities, with one-third performed at their in-house facility focusing on medical and dental products.
The platform's flexibility has proven particularly valuable for Solventum's specialized research needs. "Zelta helps expedite the build process because we can import from previously built studies," Dahling noted. "It worked out pretty slick."
Quality Control and Data Integrity
The system's impact on data quality has been substantial. Solventum measures success through meeting internal timelines and maintaining low preventable error rates. The platform's intuitive interface and real-time error correction capabilities have resulted in more efficient data entry and reduced costs.
"It's a huge benefit and time saver. The methodical flow of the screen makes for very effective data entry," Dahling stated. "Having the ability to correct those data entry errors in real-time saves a lot of time and money."
