DCN Dx Compresses IVD Trial Times by 45% with Veeva Clinical

In vitro diagnostics (IVD) clinical trials operate under unique, high-pressure parameters. Unlike traditional biopharma studies that can span multiple years, seasonal demands frequently condense IVD trials into short, intense windows.

Thomas Martinache, associate director of data management at DCN Dx, shared how the specialized diagnostic Contract Research Organization (CRO) modernized clinical operations by migrating away from fragmented systems to a connected clinical platform.

Compressed IVD trial timelines

For DCN Dx, clinical activity peaks around the fall and winter respiratory disease seasons. These trials are highly time-sensitive, so the team faces pressure to execute a complete study, from database build to final report, within four to six months while recruiting 500 to 1,000 patients/participants. “Everybody that has a product wants to start in November because suddenly they read that flu season is starting…and we need to finish the study before the end of the flu season,” said Thomas Martinache, associate director, data management.

Managing the influx of data, while adhering to study timelines, is incredibly difficult with manual, paper-based systems. To handle compressed timelines efficiently, DCN Dx needed a connected, digital system where clinical applications could communicate seamlessly without the need to rebuild integrations for every modification.

A phased approach to a unified clinical platform

Instead of attempting to adopt multiple systems simultaneously, DCN Dx implemented a phased, iterative roll-out to ensure operational continuity. The CRO began by implementing Veeva eTMF, moving all trial master files out of shared folders into a secure, audit-ready cloud environment.

DCN Dx then prioritized Electronic Data Capture (EDC) enablement. By prioritizing EDC and building an internal data management team, DCN Dx can now develop databases and deploy mid-study changes directly – eliminating the long timelines of coordinating with external partners.

To further optimize efficiency, the team decided to add and integrate Veeva CTMS to connect their trial management directly with Veeva EDC, giving project managers and clinical research associates immediate visibility into enrollment and site performance metrics.

“We like to be able to provide answers to sponsors fast and provide them access to their data,” Martinache said.

Speed, compliance, and rapid closeouts

By replacing disconnected systems with updated processes and a unified clinical platform, DCN Dx achieved significant, measurable improvements across their clinical operations.

• 45% Reduction in EDC build times: Building and maintaining a robust library of pre-made, standardized forms, queries, and variables can reduce EDC database build times by up to 45%.
• Accelerated monitoring cycle times: Because Veeva CTMS automatically pulls data from Veeva EDC, monitoring reports function as living documents, eliminating manual data entry. This enables CRAs to routinely finalize monitoring visit reports within 48 hours of a site visit.
• Three day data turnaround: During a time-sensitive, government-funded study with an abrupt closeout deadline, DCN Dx was able to complete monitoring, finalize reports, and export the full TMF within three days of the final site visit by leveraging the connected data and master files in the Veeva Clinical Platform.
• Audit readiness in minutes: During a recent regulatory audit, the team utilized Veeva’s pre-validated package to locate and deliver the exact validation documentation to the auditor within 30 minutes, leading to an immediate, successful resolution.

Lessons learned

DCN Dx needed a system that could keep up with the intensity and rigor IVD studies require. Martinache shared three key lessons learned for other medtechs and CROs looking to achieve similar results:

1. Prioritize system quality: When selecting a software, choosing the platform that scales with your team’s needs ensures long-term sustainability.
2. Keep core competencies in-house: Consolidating data management, biostatistics, and regulatory expertise internally rather than relying on external contractors drastically accelerates response times.
3. Unity is essential for tight turnarounds: Data silos can cause crippling delays. Utilizing a fully connected suite eliminates the need to rebuild vendor connections during system updates and enables rapid study execution.

What’s next

Following their success with Veeva eTMF, EDC and CTMS, DCN Dx plans to continue expanding its digital infrastructure to include advanced database reporting tools to provide deeper operational insights for CRAs. The CRO is also exploring Veeva Site Connect to streamline document exchange directly with clinical research sites.

For similar insights, read how medtechs are navigating the Complex World of IVD Clinical Trials.