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Viedoc Technologies AB (Headquarter: Uppsala, Sweden; CEO: Mats Klaar; hereinafter “Viedoc”) and A2 Healthcare Corporation (Headquarter: Bunkyo-ku, Tokyo; President and CEO: Hitoshi Kamiya; hereinafter “A2”) have initiated the joint development of an innovative RBM solution leveraging the “Kondo-method.” This approach combines A2’s deep expertise in risk-based monitoring with insights from an academic article on RBM authored by Dr. Hidenobu Kondo (A2). Together, these elements are designed to deliver a more efficient and effective approach to monitoring in clinical trials.

In the pharmaceutical and medical device industry’s clinical development, speed and efficiency are essential; however, there is still a lack of progress in optimizing monitoring by reducing the scope and frequency of on-site monitoring using RBM. Factors include the dependence on traditional on-site monitoring, fear of erroneous data both critical and non-critical when on-site monitoring is reduced, and the barrier of introducing some RBM systems.

To solve these challenges, A2 developed the “Kondo-method.” This method contributes to ensuring the safety of participants and the data quality across all types of clinical trials, as well as to reducing costs. It is a truly risk-based approach that is not only reducing costs, but also reacting to observed risk. The foundational article for the “Kondo-method,” titled “Evaluation of Data Errors and Monitoring Activities in a Trial in Japan Using a Risk-Based Approach Including Central Monitoring and Site Risk Assessment,” has won the 2022 Drug Information Association (DIA) Global Inspire Award for Author of the Year and is widely recognized globally.

Viedoc provides a dependable Electronic Data Capture (EDC) system, known for its intuitive interface and well-designed functionality. With a global footprint spanning over 7,000 clinical trials in 75+ countries, Viedoc simplifies and enhances clinical data management. Viedoc and A2 are collaborating to incorporate the “Kondo-method” into the development of Viedoc’s upcoming RBM solutions, ensuring the valuable insights and findings of the Dr. Hidenobu Kondo’s research form a strong scientific framework of the overall solution. This is a unique product, based on the award-winning article recognized at the DIA Global Inspire Awards, enabling reduction of monitoring scope and frequency on the EDC system based on evidence. The new feature implementing the “Kondo-method” is planned for release in the second half of 2025.

Both companies aim to combine their expertise to jointly develop support for RBM in an EDC that is used worldwide, to achieve more efficient monitoring, and to bring benefits to sites, pharmaceutical companies, medical device companies and CROs. This initiative not only streamlines the development process by reducing site visits for monitoring but also contributes to a sustainable future by reducing CO2 emissions. Furthermore, A2 remains committed to serving as a comprehensive provider of eClinical Solutions. We will continue to offer a range of EDC and RBM systems to meet the specific needs of our clients and the scale of their trials. This includes the provision of our co-developed products.

We aim to fulfill the social mission to deliver new medical treatments to as many patients as possible, as soon as possible.

※Source: 2022 DIA Global Inspire Award for Author of the Year
https://www.diaglobal.org/ja-jp/get-involved/awards?group=f7f3874f-2442-4784-92f7-ffffcf7880f2

For more infomation：
Joint Product Development between ViedocA2Helthcare