Verified Clinical Trials (VCT), the global leader in clinical trial subject registry solutions, has officially launched operations in Japan through a strategic collaboration with Medical Revolutions Japan (MRJ) and the Japan Association of Contract Institutes for Clinical Pharmacology (JACIC). The initiative addresses the growing global challenge of duplicate and professional research subjects in clinical trials, a concern that has expanded beyond Phase 1 studies to affect Phase II and Phase III trials as well.
Modernizing Japan's Clinical Trial Infrastructure
For the past thirty years, Japan's only system for preventing duplicate subject registration was developed by JACIC and used exclusively across Phase 1 studies. However, a recent review concluded that the system requires substantial modernization to meet international standards and support the growing number of global clinical trials conducted in Japan.
After extensive evaluation, the VCT platform was selected as the best solution and replacement for the existing system. The platform is widely adopted as the global standard for clinical trial subject registry solutions.
Advanced Biometric Capabilities and Expanded Coverage
With support from MRJ, which was commissioned by JACIC to assist with domestic implementation, Verified Clinical Trials has begun initiating sites in Japan. Additional sites are expected to join in the coming weeks and months, benefiting from the biometric capabilities of the VCT system that offer a higher level of subject authentication and protocol compliance.
The rollout will include sites conducting Phase I through Phase IV clinical trials, representing a significant expansion from the previous system's Phase 1 limitation. "Given the sophisticated functionality and biometric identification capability of the VCT system, as well as its proven match for other Asian countries," a representative of MRJ commented, "I believe it is destined to become the new Japan standard for duplicate subject registration prevention."
Global Platform with Real-Time Protection
Verified Clinical Trials brings to Japan a cross-sponsor, cross-therapeutic area subject registry already in use in up to 40 countries. The platform not only detects but also prevents duplicate subjects and other protocol violations at the time of screening and maintains protections throughout the entire duration of the trial.
"We're honored to bring VCT to Japan as part of a shared mission to raise the standard of subject protection and trial integrity," said Mitchell Efros, MD, President and CEO of Verified Clinical Trials. "No clinical trial or geography is immune to the challenge of duplicate subjects—it's a global phenomenon. Our system provides an effective, scalable solution."
Enhanced Protocol Risk Management
The implementation provides sponsors with real-time tools for proactive protocol risk management. "By introducing VCT in Japan, sponsors gain a real-time tool to proactively manage protocol risk and ensure only qualified participants are enrolled," added Kerri Weingard, ANP, Vice President and Chief Operating Officer of Verified Clinical Trials.
Regional Commitment and Support
The launch represents VCT's commitment to regulatory excellence and regional partnership across the APAC region. "This launch represents our commitment to regulatory excellence and regional partnership across the APAC region," said Eve Hsu, Global Regulatory Director at Verified Clinical Trials. "With dedicated team members based throughout APAC, we're well-positioned to support sites and sponsors locally and help elevate clinical trial quality and compliance across the region."
The VCT system was co-founded by Mitchell Efros, MD, and Kerri Weingard, ANP, both experienced clinical researchers who developed the registry to address long-standing challenges in subject eligibility, data quality, and compliance. The platform fills a critical gap in the clinical research industry by providing insight into a research subject's past trial participation, enabling better subject selection and helping ensure successful clinical trial execution.
