Standardizing Clinical Data to Drive Monitoring Visit Report Compliance
As medtech organizations strive to bring life-enhancing devices to market faster, clinical data quality and operational speed differentiate the leaders from the pack.
To globally scale clinical studies and product time-to-market, a leading global medtech harmonized its operating model by moving away from manual processes to a unified and efficient digital platform.
Their senior director of clinical operations and research, and a manager of clinical data management, discussed their own data optimization efforts as they transitioned from fragmented legacy systems to a unified clinical platform.
Leveraging the ³Ô¹Ï±¬ÁÏ Clinical Platform, their organization achieved several tangible efficiencies and established a foundation for accelerated data management.
Overcoming the burden of legacy systems
Their transformation began in three distinct phases: independent manual systems, semi-automated but disconnected systems, and finally, full integration.
During the manual era, they faced significant challenges including:
- Manual data entry: Teams relied on thousands of Excel worksheets, paper CRFs, and Post-it notes to track study progress.
- Integration gaps: Data was manually extracted from a legacy EDC and uploaded into ³Ô¹Ï±¬ÁÏ CTMS using a data loader.
- Time-intensive QC: Integration processes cost the organization approximately 1,000 hours per year across multiple individuals.
- Batch processing: Edit checks were run in batches rather than in real time, slowing down the data review process.
These factors led to inefficiencies that consumed more budget, time, and resources.
Driving efficiency through a unified clinical platform
In order to drive further efficiency and optimize the use of ³Ô¹Ï±¬ÁÏ eTMF and CTMS, their team began to harmonize their clinical processes in 2019. This enabled some automated processes, but fell short of a fully connected clinical solution.
More recently, they have completed the third phase of their unified vision by implementing ³Ô¹Ï±¬ÁÏ EDC for their Complex Aneurysm Registry (CAR) study. During this study, the team utilized ³Ô¹Ï±¬ÁÏ EDC to eliminate inefficiencies between various disjointed systems. Productized connections simplified data validation and reduced complexity of day-to-day activities within data management.
With their connected operations and data approach, they saw immediate results, driving individual monitoring visit (IMV) report compliance from approximately 60–70% to over 85%.
The organization also saw a dramatic improvement in reporting efficiency, reducing the number of reports per study from 140 to roughly 30. By implementing real-time edit checks, they were able to shift the focus of data managers from manual tracking toward analyzing meaningful data insights.
“I’d rather spend the time looking at data and listening to the data than trying to track if this is the right thing and doing a pencil and paper type of activity,” says their senior director of clinical operations and research.
Strategic advice for medtech leaders
Their disciplined approach to change management, rather than just implementing new technology, was key to their success. The team recommends a “crawl, walk, run” strategy.
- Start small: Avoid a “big bang” approach by implementing eTMF first and gradually add modules as the team is ready for change .
- Standardize CRFs: Ensure consistency and reproducibility by standardizing case report forms across various entities, regardless of the therapeutic area.
- Prioritize people: Put yourself in the shoes of the end users, CRAs and CTAs, to ensure they understand the system’s full capabilities.
- Move at the speed of trust: Build a deep partnership with your technology provider to develop solutions, such as core lab or safety adjudication, that serve the entire medtech industry.
To hear more about running efficient trials with a unified clinical platform, watch this short video.