Broken Testing Process Holding Back Clinical Trials
Clario is a leading provider of Electronic Patient Reported Outcomes (ePRO) solutions and
consulting services. Their eCOA platform specializes in helping its customers strategically use patient-, clinician-, and observer-reported outcomes data to support labeling claims, enhance reimbursement strategies, and meet other clinical program objectives.
As a clinical trial solution provider, Clario must ensure their customers can run smooth clinical programs. However, their internal testing process was a major bottleneck, undermining their ability to deliver.
Clario had an immature testing process, which stretched to 15 days or more, and used paper
records to document their testing. The testing process was purely a waterfall structure, as team members worked in silos and reacted to issues, rather then preventing them
The broken process resulted in a shocking defect rate in production, with over 21% of studies released each month having critical bugs reported. Fixing these post-release defects caused massive productivity losses, costly compliance documentation, and project delays.
To overcome these challenges, Clario needed a complete overhaul: a modern, agile workflow, a highly skilled testing team that could integrate seamlessly, and a new standard for quality assurance that would drive post-release defects to near zero.
Building A Long-Term Testing Strategy
To fix its quality crisis, Clario required a partner with deep expertise in both testing and the healthcare domain to build a strong QA strategy from the ground up, tailored to the unique compliance needs of clinical trials. The objective was clear. Clario needed predictable quality at scale, rigorous traceability from requirements to release, and practices that would stand up to sponsor and regulatory audits in every region where studies were conducted.
KMS Technology engaged as Clario’s long-term strategic QA partner. We began by dismantling the waterfall structure and implementing a modern, agile workflow. Backlog items were refined with testability in mind, and each sprint produced working, testable increments. We introduced qTest to create a reusable test case library and provide real-time, digital tracking of the entire defect life cycle, eliminating paper-based processes and increasing transparency.
Our tailored solution was built to drive down test times while dramatically improving quality. We established a highly skilled, integrated testing team that worked hand-in-hand with Clario’s developers. During the collaboration, we also embraced Agile practices to foster a culture of shared responsibility and accelerating feedback loops.
The new, optimized process cut testing cycle durations by over 50%, ensuring a faster time-to-market. Environments were used more efficiently, regression windows were shortened, and signoff became a predictable, data-backed step rather than a bottleneck. The efficiency gain was so significant that it expanded Clario’s overall delivery capacity, allowing them to release approximately six additional studies each month. This increase in throughput was achieved without lowering the quality bar, since evidence, traceability, and audit readiness improved alongside speed.
Stronger Testing Drives Faster Breakthroughs
The 11+ year partnership between KMS Technology and Clario has been a story of continuous improvement and transformative results. By providing strategic technical guidance and hands-on execution, KMS helped Clario’s engineering teams grow their business capabilities and dramatically improve their output, getting life-saving clinical studies completed faster.
KMS worked side by side with Clario’s teams to standardize workflows, deepen automation coverage, and build a culture of prevention rather than detection. Coaching and enablement ensured that new practices took root. Clear definitions of “ready” and “done,” risk-based test planning, and stronger traceability from requirements to release created consistent expectations across projects. This clarity reduced rework, shortened feedback loops, and made each release more predictable.
“Working with other vendors often feels like a numbers exercise, just people filling roles. With KMS, it’s clear they understand why we do what we do. That makes all the difference.”
The new process led to over $1.05 million in annual cost savings, with $150K from eliminating rework and fines and $900K in saved labor costs. The overall testing effort was reduced by 60%. Most critically, confidence in quality skyrocketed as post-release defect leakage decreased from 21% to just 0.7%.
In addition, by reducing 58% of manual labor and 60% of testing effort, KMS empowered Clario to shift their focus to bringing on more new clients each month, generating a direct contribution to the bottom line.