Overview
Verified Clinical Trials, a global leader in clinical trial subject registry solutions, has officially launched operations in Japan through a collaboration with Medical Revolutions Japan (MRJ) and the Japan Association of Contract Institutes for Clinical Pharmacology (JACIC) to address the growing global challenge of duplicate and professional research subjects in clinical trials.
Concerns for continuous trial subject duplication
- For the past thirty years, Japan’s only system for preventing duplicate subject registration was developed by JACIC and used 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.
- In addition, duplicate subjects in clinical trials have become a growing concern in phase II and phase III trials as well.
- After extensive evaluation, the Verified Clinical Trials platform - widely adopted as the global standard - was selected as the best solution and replacement.
Trial initiated in Japan
- With the support of MRJ, which was commissioned by JACIC to assist with domestic implementation, Verified Clinical Trials has begun initiating sites in Japan, with additional sites expected to join in the coming weeks and months.
- These sites will benefit from the biometric capabilities of the VCT system, offering a higher level of subject authentication and protocol compliance.
- This rollout will include sites conducting phase I through phase IV clinical trials.
Statement from the side of MRJ
Given the sophisticated functionality and biometric identification capability of the Verified Clinical Trials 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.”
Preventing clinical duplication
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.
Words from CEO of Verified Clinical Trials
We’re honored to bring Verified Clinical Trials to Japan as part of a shared mission to raise the standard of subject protection and trial integrity,” said Mitchell Efros, president & 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.”
From vice president of Verified Clinical Trials
By introducing Verified Clinical Trials 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 COO of Verified Clinical Trials.
From Global regulatory director at Verified Clinical Trials
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.”
About the trial system
The Verified Clinical Trials 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.