Zydus Therapeutics enters a new phase of clinical growth

Zydus Therapeutics, part of the broader Zydus Cadila group, has been steadily expanding its clinical research footprint, with an increasing number of studies moving through its pipeline. As the organization scaled its clinical operations, the complexity of managing trial documentation grew just as quickly.

To support this next stage of growth, the team needed a modern electronic Trial Master File (eTMF) system that could keep pace with both operational demands and regulatory expectations.

When existing systems stopped keeping up

As study volume increased, Zydus began to feel the limitations of its previous eTMF setup.

Routine documentation tasks became harder to manage efficiently, and teams were spending more time navigating the system than actually using it to support clinical work. Oversight across studies also became more fragmented, making it harder to maintain a clear, real-time view of trial status.

The challenge wasn’t just about software. It was about reclaiming time and focus for clinical operations.

“We knew Montrium could provide us with the tools that we need and we’re confident that the guidance we receive will keep us on the right path,” said Kimberly Swint, Manager of Clinical Trials Documentation.

Searching for a system built for scale

Zydus had already experienced the limitations of prior vendors, which made the decision to reassess their eTMF strategy critical.

What they needed was not only a capable platform, but a system designed to support growth into more complex phases of clinical development, including Phase III studies.

They selected Montrium’s eTMF Connect to provide both the technology and the operational support required to move forward confidently.

Streamlining trial documentation end-to-end

With eTMF Connect in place, Zydus introduced a more structured and efficient approach to managing trial documentation.

Teams were able to move away from fragmented workflows and instead rely on a centralized system for document handling, review, and organization. Features such as the staging area, auto-populating process zones, and inbound QC controls helped reduce manual effort and improve consistency across studies.

Study start-up processes also became more efficient through pre-defined site and contact management, allowing teams to move faster without sacrificing compliance or quality.

For newer employees, the intuitive interface significantly reduced the learning curve, making onboarding smoother and more consistent across the organization.

Building confidence across clinical operations

As adoption matured, the impact of eTMF Connect extended beyond day-to-day efficiency gains.

Review workflows became easier to manage through improved filtering and navigation tools. Document placement and organization became more automated, reducing time spent on manual indexing. And overall visibility into trial documentation improved, giving teams a clearer understanding of study status at any point in time.

The system also strengthened onboarding and training processes, helping both new and experienced employees adapt quickly and maintain consistency in how documentation was managed.

Impact summary

By implementing eTMF Connect, Zydus Therapeutics significantly improved the efficiency and visibility of its clinical trial documentation processes. The organization streamlined study start-up, reduced manual documentation effort, and strengthened oversight across its clinical portfolio. The result was a more scalable and user-friendly eTMF environment that better supports growth into advanced clinical phases.