
Verified Clinical Trials Launches in Japan in Partnership with Medical Revolutions Japan (MRJ) and JACIC to Prevent Duplicate and Professional Subjects in 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.'
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 VCT platform—widely adopted as the global standard—was selected as the best solution and replacement.
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.
'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.'
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.'
' 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.
'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.
About Verified Clinical Trials (VCT)
Verified Clinical Trials is the world's largest research subject database registry designed to detect and prevent duplicate and professional subjects in clinical trials. VCT fills a critical gap in the clinical research industry by providing insight into a research subject's past trial participation. This enables better subject selection and helps ensure successful clinical trial execution. Active in up to 40 countries, VCT supports sponsors, CROs, and research sites across all trial phases and therapeutic areas, enhancing data quality, subject safety, and protocol compliance.
About Medical Revolutions Japan (MRJ)
Medical Revolutions Japan is a clinical trial consultancy managed and staffed by industry experts with long and rich experience in all facets of clinical development and research in the Japanese market. Founded in 2024 as an affiliate of Keikokai Medical Corporation, a longstanding clinical research unit operator in Tokyo, MRJ is currently expanding its global client base and working to connect both international and local players to help the domestic Japanese clinical development industry rise to the challenges brought about by technological disruptions as it continues to grow and internationalize.
Hashtags

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles


Business Wire
19 minutes ago
- Business Wire
Cadrenal Therapeutics Announces Clinical Trial Initiation Plans for Tecarfarin in Patients with End-Stage Kidney Disease (ESKD) Transitioning to Dialysis
PONTE VEDRA, Fla.--(BUSINESS WIRE)--Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company focused on developing transformative therapeutics that specifically address limitations of current anticoagulation therapy, today announced clinical trial initiation plans for its lead late-stage drug candidate, tecarfarin, in patients with ESKD who are transitioning to dialysis. Enrollment is planned to begin later this year and will include patients with and without atrial fibrillation (AFib). There is a critical need for safe, effective anticoagulants for use in ESKD patients. Tecarfarin's orphan drug and fast-track designations in ESKD patients with AFib underscore this need, and we are excited to advance this program. Share Patients with severe kidney disease are already at high risk for thrombotic cardiovascular events such as myocardial infarction and stroke, along with a much greater risk of AFib and venous thromboembolism compared to subjects with normal kidney function. When ESKD patients require dialysis, their transition period comes with even greater risk of myocardial infarction, stroke, and a substantial increase in mortality. 'There is a critical need for safe, effective anticoagulants for use in ESKD patients,' said Quang X. Pham, Chairman and CEO of Cadrenal Therapeutics. 'Tecarfarin's orphan drug and fast-track designations in ESKD patients with AFib underscore this need, and we are excited to advance this program. This study will be an important step forward for the continued development of tecarfarin in ESKD and in other areas with real opportunities to improve patient outcomes with a potentially better vitamin K antagonist.' Currently, there is limited evidence supporting the use of anticoagulant therapy in dialysis patients. Dialysis patients are often excluded from clinical trials due to their high underlying risk profile, and studies of direct oral anticoagulants (DOACs) in this patient population have not provided clear answers. Furthermore, a recent Phase 2 trial of chronic hemodialysis patients sponsored by a global company showed no benefit from the new class of Factor XI inhibitors in maintaining vascular access graft patency. To date, no prospective studies have examined the benefit of oral anticoagulation in preventing thrombotic events at the time of dialysis initiation. 'Initiating dialysis carries substantial excess risk of cardiovascular events and mortality, and to date, this risk has not been sufficiently addressed. Tecarfarin, a next-generation Vitamin K antagonist with a unique metabolism pathway that is not significantly affected by kidney impairment, has potential promise in this area of unmet need,' said Wolfgang Winkelmayer, Professor of Medicine and Chief of Nephrology at Baylor College of Medicine in Houston, Texas. About Cadrenal Therapeutics, Inc. Cadrenal Therapeutics, Inc. is a biopharmaceutical company developing transformative therapeutics to address limitations of current anticoagulation therapy specifically. Cadrenal's lead investigational product is tecarfarin, a novel oral vitamin K antagonist anticoagulant that is designed to address unmet needs in anticoagulation therapy. Tecarfarin is a reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Although warfarin is widely used off-label for several indications, extensive clinical and real-world data have shown it can have significant, serious side effects. With tecarfarin, Cadrenal is advancing an innovative solution to address the unmet needs in anticoagulation therapy, aiming to reduce the clinical complexities of managing Vitamin K antagonists and where DOACs remain inadequate or unproven. Tecarfarin received Orphan Drug Designation (ODD) and fast-track status for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease and atrial fibrillation (ESKD+AFib). The company also received ODD for the prevention of thromboembolism and thrombosis in patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs). The company has submitted an Orphan Drug Designation Request to the US FDA for patients with chronic kidney disease who have an implanted mechanical heart valve (and consequently require lifelong anticoagulation with a VKA) who also have genetic predisposition to impaired CYP2C9 metabolism, and resulting associated challenges with achieving reliable degrees of anticoagulation with the long-term use of warfarin. Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. For more information, visit and connect with us on LinkedIn. Safe Harbor Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute 'forward-looking statements.' The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potentially,' 'predict,' 'project,' 'should,' 'target,' 'will,' 'would' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding initiation of clinical trial for tecarfarin in patients with ESKD transitioning to dialysis; initiation of registration trial in patients with ESKD and AFib, developing transformative therapeutics to specifically address limitations of current anticoagulation therapy; addressing a critical current treatment gap in patients with ESKD; enrollment in the planned clinical trial beginning later this year; the planned study being an important step forward for the continued development of tecarfarin in ESKD; improving patient outcomes with a potentially better vitamin K antagonist; tecarfarin offering potential promise in patients initiating dialysis; addressing the unmet needs in anticoagulation therapy; and Cadrenal's ability to pursue business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to develop transformative therapeutics to specifically address limitations of current anticoagulation therapy; the ability to address a critical current treatment gap in patients with ESKD; the ability to advance an innovative solution to address the unmet needs in anticoagulation therapy; the ability to initiate and successfully complete clinical trials on time and achieve desired results and benefits as expected; the ability of Cadrenal to build a pipeline of specialized cardiovascular therapeutics and other assets and the other risk factors described in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, and the Company's subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.


Business Wire
2 hours ago
- Business Wire
Polpharma Biologics and Fresenius Kabi Sign Licensing Agreement for Proposed Vedolizumab Biosimilar PB016
AMSTERDAM, ZUG, Switzerland & GDAŃSK, Poland--(BUSINESS WIRE)--Polpharma Biologics S.A. ('Polpharma Biologics') announces a global (except for Middle East & North Africa) licensing agreement with Fresenius Kabi for the commercialization of PB016, a proposed biosimilar to vedolizumab, an integrin receptor antagonist, (reference product: Entyvio®*), a biologic therapy indicated for moderate to severe ulcerative colitis and Crohn's disease. Under the terms of the agreement, Polpharma Biologics will lead development and manufacturing of PB016, while Fresenius Kabi will hold exclusive commercialization rights worldwide, excluding Middle East & North Africa. 'This partnership reinforces our mission to broaden access to high-quality biologics that improve patient outcomes globally,' said Konstantin Matentzoglu, Supervisory Board Member of Polpharma Biologics Group. 'Fresenius Kabi's deep commercialization experience and commitment to biosimilars make them an ideal partner for bringing PB016 to patients worldwide. Together, we are taking an important step toward addressing the rising burden of chronic inflammatory diseases.' The agreement builds on Polpharma Biologics' growing biosimilar portfolio and proven development capabilities. The company has previously brought forward multiple biosimilars — including ranibizumab and natalizumab — across global markets in partnership with leading pharmaceutical companies. This strategic collaboration strengthens both companies' commitments to expanding global access to affordable biologic medicines while supporting healthcare system sustainability. *Entyvio® is a registered trademark of Takeda. About Polpharma Biologics: Polpharma Biologics is an international biotechnology company with integrated operations in the European Union (EU), developing and manufacturing biosimilar medicines. Using patented solutions and state-of-the-art platform technologies, Polpharma Biologics develops biosimilar products to treat a range of conditions in major therapeutic areas. Programs at Polpharma Biologics start in cell line development and transition through technical and clinical development to commercial-scale production preparing drugs for future commercial partnerships with global pharmaceutical organizations. The expertise of Polpharma Biologics lies in the development and manufacture of medicines based on microbial and mammalian expression systems. With its cell line development center in the Netherlands and two centers of development and manufacturing in Poland, Polpharma Biologics creates growth and development opportunities for biotechnology specialists. Learn more at About Fresenius Kabi: As part of the global healthcare company Fresenius, Fresenius Kabi specializes in (bio)pharmaceuticals, medical technologies and nutrition products for critical and chronic conditions. The company's products, technologies, and services are used for the therapy and care of critically and chronically ill patients. With more than 41,000 employees and present in over 100 countries, Fresenius Kabi's expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies. For more information, please visit Important Note This press release is for informational purposes only and does not constitute promotional material for PB016 in Poland or any other jurisdiction. The commercialization of proposed vedolizumab biosimilar PB016 is solely the responsibility of Fresenius Kabi, the marketing authorization holder, in accordance with all applicable laws and regulations. Disclaimer This press release is issued from Polpharma Biologics Group and is intended to provide worldwide information to healthcare professionals, media and (potential) investors about our global business in relation to drug development and manufacturing expertise. Although Polpharma Biologics Group is not a public company as of this date, recipients should understand that this press release contains certain forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). These statements involve inherent risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the approval and commercialization of the medicinal product, market reception, competition, changes in economic conditions and applicable laws, global regulatory developments, contractual risks and dependencies from third parties. Polpharma Biologics undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release. Moreover, Polpharma Biologics wishes to emphasize that this press release is for informational purposes only and shall not be construed as making any representation, warranties, or guarantees, either express or implied, regarding the potential approval, market reception, commercialization, or success of the medicinal product or any other product or therapy.


Business Wire
3 hours ago
- Business Wire
Mission Success for Rocket Lab's Latest Constellation Deployment Launch for iQPS
MAHIA, New Zealand--(BUSINESS WIRE)--Rocket Lab Corporation (Nasdaq: RKLB) ('Rocket Lab' or 'the Company'), a global leader in launch services and space systems, today successfully launched its 69 th Electron mission and deployed the latest satellite to orbit for Institute for Q-shu Pioneers of Space, Inc. (iQPS) - Rocket Lab's fifth dedicated mission in a multi-launch contract to build their constellation in low Earth orbit. 'The Harvest Goddess Thrives' mission lifted off from Rocket Lab Launch Complex 1 in New Zealand at 04:10 UTC on August 5 th. Electron deployed a single synthetic aperture radar (SAR) imaging satellite named QPS-SAR-12 (nicknamed KUSHINADA-I for the Japanese goddess of harvest and agriculture) to a 575km circular Earth orbit. It was Rocket Lab's fourth launch this year for iQPS and fifth mission overall, making Electron the most prolific launcher of their constellation to date. Four more dedicated iQPS missions are scheduled to launch on Electron through the remainder of this year and in 2026. Rocket Lab Founder and CEO, Sir Peter Beck, says: 'Every Electron launch is a demonstration of payload deployment precision for our customers – an especially critical element when scaling satellite constellations. Today's fifth and flawless deployment for iQPS once again underscores Electron's reliability and continues to prove that consistent tailored access to space is a reality on Electron for our customers.' iQPS CEO, Dr. Shunsuke Onishi, says: 'Building a satellite constellation requires both timely development and manufacturing, as well as highly precise launch execution. We are deeply grateful to both our team and the Rocket Lab team for their continued dedication in making this possible. As the number of satellites increases, so too does the frequency and value of the data we are able to provide. We will continue to accelerate our efforts to ensure that our satellite data can be leveraged in even more fields and applications.' 'The Harvest Goddess Thrives' marks Rocket Lab's 11th Electron mission of 2025 and its 69 th launch overall. Details of the next Electron launch will be shared in the coming days. Launch images: About Rocket Lab Founded in 2006, Rocket Lab is an end-to-end space company with an established track record of mission success. We deliver reliable launch services, satellite manufacture, spacecraft components, and on-orbit management solutions that make it faster, easier, and more affordable to access space. Headquartered in Long Beach, California, Rocket Lab designs and manufactures the Electron small orbital launch vehicle, a family of spacecraft platforms, and the Company is developing the large Neutron launch vehicle for constellation deployment. Since its first orbital launch in January 2018, Rocket Lab's Electron launch vehicle has become the second most frequently launched U.S. rocket annually and has delivered over 200 satellites to orbit for private and public sector organizations, enabling operations in national security, scientific research, space debris mitigation, Earth observation, climate monitoring, and communications. Rocket Lab's spacecraft platforms have been selected to support NASA missions to the Moon and Mars, as well as the first private commercial mission to Venus. Rocket Lab has three launch pads at two launch sites, including two launch pads at a private orbital launch site located in New Zealand and a third launch pad in Virginia. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward looking statements contained in Section 27A of the Securities Act of 1933, as amended (the 'Securities Act') and Section 21E of the Securities Exchange Act of 1934, as amended (the 'Exchange Act'). All statements contained in this press release other than statements of historical fact, including, without limitation, statements regarding our launch and space systems operations, launch schedule and window, safe and repeatable access to space, Neutron development, operational expansion and business strategy are forward-looking statements. The words 'believe,' 'may,' 'will,' 'estimate,' 'potential,' 'continue,' 'anticipate,' 'intend,' 'expect,' 'strategy,' 'future,' 'could,' 'would,' 'project,' 'plan,' 'target,' and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including but not limited to the factors, risks and uncertainties included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission (the 'SEC'), accessible on the SEC's website at and the Investor Relations section of our website at which could cause our actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.