Viedoc and A2 Healthcare partner to advance smarter risk-based monitoring
Viedoc Technologies, a provider of industry-leading software for clinical trials and electronic data capture, announces its partnership with A2 Healthcare Corporation, a prominent Contract Research Organization (CRO) based in Japan, to deliver a more efficient approach to risk-based monitoring (RBM) in clinical trials. Together, the two companies are working to develop applications within the Viedoc eClinical suite that incorporate the “Kondo-method”—a streamlined, evidence-based approach to RBM pioneered by Dr. Hidenobu Kondo.
The Kondo-method is a simplified yet highly effective strategy to reduce time and cost spent on monitoring while still maintaining data quality. By partnering with Viedoc, A2 Healthcare will be able to translate this method into a functional, platform-based solution that is positioned for broad adoption across clinical studies. Notably, Dr. Kondo’s article outlining this method—“Evaluation of Data Errors and Monitoring Activities in a Trial in Japan Using a Risk-Based Approach Including Central Monitoring and Site Risk Assessment”—was awarded DIA’s “Author of the Year Award” in 2022, highlighting the scientific rigor behind the methodology.
Overcoming RBM implementation challenges
Despite growing interest in RBM across the clinical research industry, many organizations continue to struggle with effective implementation. A lack of standardized, evidence-based tools often leaves sponsors relying on assumptions or intuition when determining site risk levels. Another key challenge is that even if the site’s risk level increased, there was still a lag time before mitigating actions could be taken.
A joint solution for smarter monitoring
“This is truly a joint effort, as A2 Healthcare has been actively involved, especially during the requirements phase, to make sure what we deliver supports their innovative approach,” said Johannes Molin, Product Manager at Viedoc. “Dr. Kondo’s ability to simplify something as complex as RBM and back it up with evidence, not just assumptions, makes this solution unique.”
Dr. Kondo’s vision, Molin explained, offers a practical solution to a longstanding challenge. “Many companies are still struggling with implementing an efficient risk-based strategy for monitoring. Dr. Kondo came up with a systematic and well-defined categorization of site risk, and paired that with a clever strategy for source data review (SDR) and source data verification (SDV),” he said. “Study teams could now get systematic and reliable site risk assessments.”
Viedoc’s positive reputation in Japan, its experience from successful project deliveries over the years, and a well-established relationship with A2 Healthcare helped create a strong foundation for collaboration. With the finalization of the third revision of the International Council for Harmonisation Good Clinical Practice (ICH-GCP), where a risk-based approach to monitoring is becoming a requirement, the timing was ideal for a strategic joint initiative. The alignment of goals and shared commitment to innovation created a strong match for both companies.
Industry impact
The enhanced functionality is expected to empower sponsors with a simple, efficient, and cost-efficient solution to confidently reduce time spent on on-site monitoring without compromising quality—an industry-wide goal that has been difficult to achieve due to compliance, data integrity, and in some cases even patient safety concerns.
About A2 Healthcare
A2 Healthcare Corporation is one of the industry's leading CROs (Contract Research Organizations), conducting clinical trials under contract from pharmaceutical companies, and has been involved in the development of numerous drugs with approximately 1,300 employees in Tokyo, Osaka, Taiwan, and Boston. In addition to the traditional lifestyle-related disease area, A2 is involved in the development of drugs related to cancer, central nervous system, respiratory disease, vaccine, and also promotes the introduction of various advanced solutions such as RBM, eSource Data, eSubmission, and DCT (Decentralized Clinical Trials) to improve the efficiency of clinical trials. A2 Healthcare is also a subsidiary of ITOCHU Corporation and forms the core of the group's healthcare business.