Marvin's Impact on Study Efficiency and Data Quality
Intage Healthcare provides comprehensive solutions for a wide range of needs including pharmaceutical market research, clinical development, post-market studies, pharmaceutical rep activity support, switch-OTC market assessment and sales tracking. Intage Healthcare aims to continuously provide healthier and more beneficial “choices” to all healthcare consumers and create a society where people have lots of options and can make their own personal choices, an abundant society with vast potential. The company was founded in 1960 and is headquartered in Tokyo, Japan.
Intage Healthcare, recently conducted a study utilizing Marvin, the eClinical software of XClinical, to streamline their processes and improve data quality. This case study highlights the positive outcomes and benefits experienced by Intage during the study.
Phase III clinical study of QFR (Quantitative coronary flow ratio)
5 Sites | >200 patients | Duration of study: >10 months
The study commenced with no specific setup requirements, but the implementation of Marvin proved to be instrumental in solving various challenges faced by Intage. Although no explicit problems were mentioned, the introduction of Marvin made the overall processes more efficient and easier for the team. Marvin’s automation capabilities played a role in simplifying Intage’s daily routines, ultimately saving time and effort.
One notable advantage of Marvin was its ability to cater to multiple user groups involved in the study, including Principal Investigators (PIs) and Monitors. This versatility allowed for seamless collaboration and effective management across various roles within the study.
During the study, Intage found the reporting module of Marvin to be particularly important and valuable. This feature facilitated efficient management of patient data, study progress tracking, and report generation, empowering Intage with comprehensive oversight and control.
By employing Marvin, Intage significantly enhanced the quality of their data. The system provided real-time monitoring and validation of data, which helped ensure accuracy and reliability. This improvement in data quality is crucial for obtaining valid study results and drawing meaningful conclusions.
Throughout their experience with Marvin, Intage did not encounter any friction points or significant challenges. The system proved to be secure, stable, and user-friendly, leading to a smooth and hassle-free study management process.
Risk-based Monitoring, ePro and eCOA with Marvin
Intage also benefitted from Marvin’s risk-based monitoring function, which enhanced the efficiency of monitoring activities. By effectively utilizing this feature, site visits were reduced, resulting in cost savings and increased operational efficiency.
Additionally, the study involved both Japanese and English eCRFs, and Marvin seamlessly supported language switching without any issues, further facilitating Intage’s operations.
The success of this study has motivated Intage to consider expanding the use of Marvin in future projects. Specifically, they express a desire to integrate ePRO and eCOA functionalities with Marvin. This integration would enable seamless data collection from patients, further enhancing the accuracy and efficiency of their studies.
The use of electronic patient-reported outcomes (ePRO) and electronic clinical outcome assessments (eCOA) has become increasingly popular in clinical studies. These tools allow patients to report their symptoms and experiences in real-time, providing researchers with accurate and timely data.
Presently, Intage is in the process of submitting this study to regulatory authorities for approval. Despite the clients headquarters being in the Netherlands, the application process is proceeding smoothly in Japan.
Intage’s positive experience with Marvin showcases the system’s effectiveness in improving study efficiency, data quality, and collaboration among various user groups. The simplicity of system setup, combined with its stability and security, positions Marvin as a reliable tool for clinical data management.
As the industry continues to embrace digital solutions, the combination of Marvin with ePRO and eCOA holds promise for future studies, empowering researchers like Intage to achieve even greater efficiency and quality in their research endeavors.
We extend our heartfelt gratitude to Intage Healthcare Japan, our esteemed partner for many years, and particularly to Mr. Akira Mizuo for their invaluable insight and contributions.
XClinical, part of EvidentIQ offers an eClinical solution called Marvin, which is an End-to-End platform for managing electronic data capture (EDC) and clinical data management (CDM) in clinical trials. Marvin is designed to support the entire clinical trial process, from study setup and to data collection and analysis. The software offers a range of features and is also compliant with various regulatory requirements, including FDA 21 CFR Part 11, GCP, and CDISC standards. The software is used by various organizations worldwide, including pharmaceutical companies, contract research organizations (CROs), and academic research institutions, to improve the efficiency and quality of clinical trial data management.
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