Scaling Clinical Trial Delivery While Maintaining <1% Defect Leakage
This case study explores a project delivered by KMS Technology, a company that merged with Addepto in December 2025, for Medidata—a global leader in clinical trial technology.
Medidata was on a mission to accelerate clinical trial delivery while maintaining the highest quality standards required in regulated environments. As study volumes increased and timelines tightened, the company needed to scale its operations without compromising performance, compliance, or cost efficiency.
Partnering with KMS Technology, Medidata set out to transform its testing and quality engineering processes—enabling faster study execution, improved automation, and scalable global delivery.
Meet Our Client
Medidata, a Dassault Systèmes company, is a global leader in clinical trial technology, supporting over 36,000 trials and 11 million patients worldwide. Its platform, including Patient Cloud, enables pharmaceutical and biotech companies to design, manage, and optimize clinical studies with speed, accuracy, and compliance.
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Case Study Shortcut
Challenge
Long Study Cycle Times
An average 12-week study cycle created a growing backlog and made it difficult to meet sponsor expectations of 8-week delivery timelines.
Balancing Cost and Quality
Medidata needed to increase efficiency and reduce operational costs while maintaining strict quality standards across thousands of clinical trials.
Scaling with Global Complexity
Expanding globally introduced additional challenges, including localization requirements, legacy system integrations, and increased regulatory complexity.
Goal
The goal of the partnership was to scale Medidata’s clinical trial delivery while improving efficiency, quality, and speed.
- Reduce study cycle times and eliminate bottlenecks
- Standardize and scale quality engineering processes
- Increase automation and testing efficiency
- Maintain defect leakage below strict regulatory thresholds
- Enable growth without increasing operational costs
Outcome
KMS Technology helped Medidata transform its quality engineering into a high-performance, scalable system capable of supporting rapid growth.
Key results (2025):
- 69% increase in study volume without additional cost or quality trade-offs
- 0.5% defect leakage, significantly below the 2% target
- 1,100+ testing hours saved through automation and process improvements
- Up to 20% faster study cycle times
- 420 custom functions delivered with consistent quality
The improved processes enabled Medidata to scale efficiently while maintaining exceptional quality standards across its Patient Cloud platform.
Before
- Long and inconsistent study cycles
- Manual, fragmented testing processes
- High variability in UAT readiness
- Inefficient custom function development
- Limited scalability of QA operations
After
- Streamlined and standardized testing processes
- Faster and more predictable study delivery
- High-quality output with <1% defect leakage
- Scalable QA and automation framework
- Increased throughput without additional cost
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Case Study Details
Approach
Standardizing Study Testing & UAT Readiness
- Reduced study cycle times
- Improved UAT readiness
- Sustained defect leakage at 0.5%
- Increased delivery velocity across studies
Optimizing Custom Function Development
- More predictable development cycles
- Reduced rework and validation effort
- Increased throughput without sacrificing quality
Enhancing UAT Script Development & Execution
- Faster preparation and execution of UAT scripts
- Improved documentation and validation transparency
- Increased confidence in study readiness and launch timelines
Driving Continuous Improvement Through Automation
- Increased release volume and change requests
- High-volume UAT execution
- Continuous efficiency improvements through automation
