Effective clinical trial execution relies on clean, timely data from multiple sources. Medtech companies are transitioning to modern solutions to establish enduring connections between internal stakeholders and sites to speed trials and improve efficiency.
A global medical technology leader implemented Veeva EDC, Veeva CDB, Veeva CTMS and Veeva Payments across their life sciences, medical device, and interventional medicine business units to streamline data management, improve workflows, and reduce the burden on sites and internal teams. Since partnering with Veeva in 2020, the company has shifted clinical operations and data management from multiple legacy systems to the Veeva Clinical Platform. They currently serve over 190 countries and have produced over 37 billion devices across their three business units.
The company’s primary objectives were to standardize across business units, reduce data discrepancies and build lifecycles, and minimize manual data entry, review, and reconciliation. They took a phased approach to onboarding the three business units, with life sciences being the last to make the transition given the heavy reliance on instrument data instead of subject data.
One director of clinical data management said, “In our life sciences division the instrument data is our primary endpoint, and previously we could only capture it manually. Sites had to enter data directly into the system, which created an enormous burden on the sites and our CRAs who had to conduct a one-to-one analysis of the data.”
“In our life sciences division the instrument data is our primary endpoint, and previously we could only capture it manually.”
– Director of Clinical Data Management
Legacy systems presented barriers with data exchange between EDC and CTMS, site coordination for follow-up and fee schedules, and study tracking and reporting. These challenges were further compounded by information silos, manual processes across multiple studies, and diverse global payment requirements.
The first objective was to standardize case report forms (CRFs) and edit checks to build a standard library and then transition to specific CRFs per business unit. To date, they have implemented 39 standardized CRFs and are able to make real-time CRF updates for future builds. By revising and standardizing CRFs, they reduced average study build times by 1-2 weeks.
With CRFs and associated processes in place to improve study start-up, the company was able to streamline data management during study conduct. Uploading instrument data through CDB eliminated hours of data entry
and cleaning for the sites, data managers, and CRAs. They were also able to cut amendments from a multi-week process to 1-2 days with no system downtime.
Previously, delivering end-of-study media required a multi-step process from site documentation to acknowledgement of receipt. The company was able to transition the entire process to the Veeva Clinical Platform, reducing
prep time from 4+ hours down to a few minutes and saving 3+ weeks for a single full-time employee in some instances.
“To reduce manual efforts, we leveraged Veeva CDB to allow sites to upload data directly from the instrument. For this specific study, this resulted in a 90% reduction in manual queries, eliminated 298 hours of data entry for the sites, and reduced source data validation and reconciliation.”
– Director of Clinical Data Management
The company implemented the revised processes and new workflows on a study that was key to one of their submissions in specimen management within their life sciences portfolio. The four-week study included 230 patients and was heavily
reliant on instrument data. They were unable to pull data directly from one of the six instruments included in the study, which allowed them to test the automated process against manual data entry.
“To reduce manual efforts, we leveraged Veeva EDC to allow sites to upload data directly from the instrument. For this specific study, this resulted in a 90% reduction in manual queries, eliminated 298 hours of data entry for the sites, and reduced source data validation and reconciliation,” said another director of clinical data management. By streamlining processes and reducing manual effort, the data management team, CRAs, project managers, and sites can now allocate more time to critical study deliverables and essential details.
In addition to transforming clinical data processes, the company identified three core pillars of change to overcome challenges in the legacy process for site management. Their primary objectives included unifying information, improving collaboration workflows, and increasing interoperability and automation.
Leveraging the connection between Veeva CTMS and Veeva EDC, they have been able to automate and communicate subject activity. A senior clinical systems architecture specialist said, “data entered into Veeva EDC is automatically transferred to Veeva CTMS. Subjects, visits, and site payment requests are all in one location. We have screening visits linked back to source information, payable items generated for each visit, and dynamic changes automatically adjusted to payable items. This allows people to have better oversight over data changes with implications on payments, enabling our project teams to focus on the trial instead of administration. Simplicity here is our sophistication.”
The company embarked on this digital transformation with a long-term vision and roadmap to guide them throughout the implementation of the Veeva Clinical Platform. They established clear milestones and process improvements, including:
Watch this video to learn more how Veeva Veeva Clinical Suite can help accelerate growth of clinical trials.