Lotus Clinical Research Accelerates Trial Operations with Automated eTMF Workflows

Lotus Clinical Research, a leading CRO specializing in complex biopharma research, manages a high volume of clinical trials. In 2018, Lotus partnered with Veeva to transition from manual paper processes to a unified digital platform. This transformation was a strategic necessity to maintain efficiency amidst growing complexity. “We’re able to see exactly when the document goes in the system to when the document is approved, who viewed the document, what happened to the document, or if it had any issues. It’s helping us be not only audit-ready, but also have traceability,” says Chris Bowman, vice president, quality operations.

By integrating document automation and real-time dashboards, Lotus transformed its study management to ensure constant inspection readiness and faster trial execution. Using a “Veeva-first” approach across more than 50 studies, Lotus eliminated manual bottlenecks that slow trial start-up and document management. Intelligent automation within Veeva eTMF allows clinical teams to focus on high-value trial activities and inspection readiness.

Overcoming manual bottlenecks and binder fatigue

Manual document management created significant administrative hurdles and operational risks for Lotus. Before the digital transition, team members dealt with the physical reality of paper binders, where locating a single document often required more than 10 minutes. “You had to find the binder, get it down, and locate the document,” recalls Cydney Johnson, director of regulatory operations at Lotus.

These manual steps increased the risk of human error and naming inconsistencies, threatening study timelines and overall trial quality. Communication also suffered from data lags, with sponsors often reviewing outdated reports during weekly calls. This visibility gap prevented real-time decision-making and limited effective trial oversight.

Improving efficiency through intelligent automation

Lotus implemented document automation within Veeva eTMF to address these bottlenecks. By using historical data to suggest document locations, the system has already auto-classified more than 1,000 documents. While the automation continuously learns from user feedback to correct the minor 1% of misclassifications, the Lotus team performs a final manual quality check to ensure total accuracy.

This transition reduced document classification time from five minutes to under one minute. Beyond speed, the system provides full traceability, a new standard for ALCOA+ compliance. Clients can now conduct audits and QC directly within the TMF, with the ability to download audit trails to maximize efficiency.

“Veeva eTMF puts us in a much more confident, efficient place. We feel ready for inspections at any time because the system provides full traceability and historical accuracy.” — Cydney Johnson Director of Regulatory Operations, Lotus Clinical Research

Automation works within a unified ecosystem where Veeva eTMF, EDC, and CTMS seamlessly communicate. Visit information, enrollment data, and subject status automatically flow from EDC into CTMS, which then populates monitoring letters and reports in eTMF. This connected approach, supported by more than 50 dashboards, eliminates siloed systems and reduces manual data entry for clinical teams.

Building sponsor trust through real-time data

Real-time visibility has fundamentally changed how Lotus interacts with its sponsors. Rather than providing static reports, Lotus now utilizes live screen-sharing during sponsor meetings to display dashboards. These dashboards provide a real-time look at critical metrics, including query aging, enrollment status, and overall TMF health.

“Having immediate visibility into TMF and study activity allows us to answer sponsor questions without delay,” says Marilyn Greenwalt, senior director, clinical operations training and project management. “Both clinical operations and data management rely on these real‑time dashboards from Veeva, and that accuracy has become a key part of how we demonstrate oversight and build sponsor trust.”

Sponsors also benefit from real-time access to their own dedicated dashboards, allowing them to verify study status at any time. This transparency fosters deep trust, as sponsors can independently see that Lotus is actively working on their studies and maintaining a healthy eTMF.

Learn how Veeva eTMF improves trial efficiency and keeps you inspection ready.