Data Management Support for a Phase 3 Real World Medical Device Dermatology Trial

Case Study Introduction

A global biopharmaceutical sponsor initiated an open-label, single-arm Phase 3 clinical trial to evaluate the safety and efficacy of a biologic therapy delivered via an autoinjector in people with moderate-to-severe atopic dermatitis. The study was designed to confirm that self-administration could be reliable and user-friendly in real-world settings, while generating high-quality evidence to support decision-making.

Due to the complexity of the study, which was amplified by its connection to several parent studies, and the lack of internal resources within the sponsor, Quanticate was selected to provide clinical data management services due to our experience in handling complex studies and scaling resource requirements.

Objectives and Key Challenges

The sponsor needed to:

Demonstrate that autoinjector delivery could achieve consistent clinical outcomes and a strong safety profile over repeated use.
Build confidence that patients could use the device correctly at home, supporting long-term treatment adherence in a chronic condition.
Capture complete, consistent trial data across both clinic visits and home use—including patient experience and device-related information.

Key Challenges Included:

Ensuring dose delivery was consistent across a diverse patient population and over multiple administrations.
Managing variability in home use, including training needs, injection technique differences, and the potential for device-related issues.
Handling large volumes of complex data from multiple sources, including ePRO (electronic patient-reported outcome) devices and data from various parent trials, without missingness or inconsistencies undermining the final analysis.

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Strategic Approach and Tailored Solutions

Due to the challenges and sponsors’ needs, Quanticate had to design a particularly sophisticated and tailored data management strategy, including:

A real-time digital data capture approach using electronic data capture workflows to support timely entry, review, and monitoring of clinical data across both clinical sites and home settings. This enabled high-volume patient data, including ePRO and device performance information, to be captured and reviewed in a structured and consistent way.
Stringent quality control processes were built into the study from the outset, including automated edit checks, advanced validation checks, structured review cycles, regular audits, and data reviews. These controls helped ensure the accuracy, completeness, and consistency of the data collected, while allowing discrepancies to be identified and resolved early to reduce downstream rework.
Dedicated safety and device oversight processes supported continuous review of safety reporting and device-related events. This helped the study team surface potential issues quickly, respond with confidence, and maintain close oversight throughout the trial.
A bespoke database and integration approach was developed to accommodate the study’s complex and high-volume data inputs, including clinical, patient-reported, and device performance data. This enabled unified data review and supported reliable downstream analysis.

Successful Client Outcomes

With Quanticate’s partnership, the sponsor was able to:

Maintain strong oversight of safety, patient outcomes, and device-related data throughout the trial, including during home administration. This gave the study team timely visibility of autoinjector performance and helped them respond quickly to emerging issues.
Improve overall data quality through earlier issue detection, faster resolution cycles, and consistent validation, resulting in a cleaner, more reliable, and inspection-ready dataset.
Generate robust evidence on the effectiveness, safety, and usability of the autoinjector in long-term atopic dermatitis treatment, supporting greater confidence in the study findings.
Strengthen regulatory readiness through consistent management of a diverse and complex dataset, with appropriate controls supporting compliance, traceability, and reliable reporting.

Conclusion

This Phase 3 autoinjector medical device study delivered clear, decision-ready evidence to support the sponsor’s development programme, while reinforcing the value of a patient-centric delivery approach in chronic dermatology care. Through specialist data management services and the ability to manage and integrate a complex dataset, Quanticate helped ensure the accurate evaluation of the autoinjector’s safety, efficacy, and real-world usability, directly contributing to the scientific success of the trial.

Data Management Support for a Phase 3 Real World Medical Device Dermatology Trial

Case Study Introduction

Objectives and Key Challenges

Need support with a Real-world evidence study?

Strategic Approach and Tailored Solutions

Successful Client Outcomes

Conclusion

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