ECRFPlus Files IPO Prospectus: A Rising Star in Digital Clinical Trial Solutions
With the booming development of innovative drugs worldwide, the demand for clinical research on pharmaceuticals is growing day by day, and the market continues to expand.
Opportunities are accompanied by crises—clinical research involves multi-party collaboration, yet communication efficiency between sponsors and service providers remains low; information silos persist; the quality and integrity of clinical data urgently need improvement; and there is a lack of comprehensive solutions for the integrated management of hospital-based clinical research...Digital Clinical Research, becoming the key to breaking the deadlock.
Looking abroad, the field features established industry leaders such as Veeva and Medidata, as well as new entrants like Science37 and Medable that are seeking to offer their own solutions. Meanwhile, numerous emerging digital clinical research information technology service providers have also sprung up in China.
There is such a new digital clinical research information technology enterprise,Established in Seattle, USA, in 2002,Successfully provided electronic data capture, management, analysis, and project management services for nearly 100 pivotal Phase I–III clinical trials across dozens of pharmaceutical companies in Europe and the United States. The services have passed validation by multiple CROs and independent reviews and audits by major pharmaceutical companies in Europe and the United States, including Merck, Boehringer Ingelheim (BI), and Roche.In 2006, the founder returned to China with innovative concepts.. For two decades, we have been deeply rooted in the field of IT services for digital clinical research, working diligently to earn recognition from the market and investors. We have developed comprehensive industry solutions that combine international features with suitability for the Chinese market.
This company isHangzhou Yikefu Technology Co.,Ltd.(hereinafter referred to as"Yikefu"). Yikefu is a new digital clinical research information technology service company based on Internet+ technology, specializing inSponsor, Clinical Research Center, National Regulatory Authorityand third partiesDelivering professional IT solutions and clinical acceleration services.
Mr. Lu Min, the founder, has been dedicated to the field of clinical trial informatization for over two decades. He established ECRFPlus in the United States in 2002, and in 2006, he founded Hangzhou Yikefu Technology Co., Ltd., introducing advanced technologies and concepts from global clinical research.Beijing, Shanghai, Guangzhou, Hangzhou, Wuhan, Chengduetc., and has established a nationwide technical service center.
As a pioneer in digital clinical trials, Hangzhou Yikefu Technology Co., Ltd. has been committed to meeting the informational needs of all stakeholders involved in clinical trials and was the first in the industry to propose the concept of a 3Q Digital Clinical Trial Platform ecosystem. After years of development, the 3Q Digital Clinical Platform has attracted a large number of sponsors, clinical trial institutions, investigators, CRCs, CRAs, and other clinical research participants, earning high recognition from prestigious organizations such as West China Hospital of Sichuan University, Fudan University Shanghai Cancer Center, IQVIA, Pfizer, and AstraZeneca.
According to Lu Min, the “3Q” concept proposed by Hangzhou Yikefu Technology Co., Ltd. as early as 2015 represents Quality for hospitals, regulators, and sponsors, which aligns with the recently introduced OneQMS philosophy in the industry. Its other interpretation encompasses whole-process management (Q), full-cycle dynamic supervision (Q), and comprehensive quality assurance (Q). This approach is consistent with the current direction of informatization development in clinical trials in Europe and the United States, demonstrating the advanced nature and forward-looking perspective of Yikefu’s solutions.
According to Lu Min, the clinical trial information flow consists of two interconnected loops: one at the sponsor end and the other at the hospital end. Relative to the hospital, we refer to the former as the “external loop” and the latter as the “internal loop.” These two loops have long operated independently, requiring manual transfer of information from one loop to the other—a persistent and formidable challenge for the industry.
“To address this issue, we need to separately implementInformatization of Internal and External Circulationand digitalization, while also needing to address thisIssues of Safe and Compliant Interaction Between Two Loops.” Lu Min analyzed.
There are currently many mature providers of “external loop” solutions on the market. Over the past two years, some platforms have attempted to use Decentralized Clinical Trial (DCT) technologies to collect clinical research-related data directly or remotely from patients, storing the source data in their proprietary systems, thereby partially addressing the issue of manual data entry. According to Lu Min, such hospital-independent solutions may pose compliance risks and potential quality concerns.
The slow development of clinical informatics within the “internal circulation” is largely attributable to the highly complex logic underlying hospital clinical trial management. Constrained by their technical frameworks and a lack of in-depth understanding of hospital-based clinical research, informatics vendors struggle to propose fundamental solutions for integrated platforms that unify clinical care and scientific research in hospitals.
“Therefore, the first step in addressing the industry’s pain points is to help hospitals establish an integrated clinical research information platform; the second is to provide solutions that integrate internal and external circulation.”Lu Min introduced。Based on this, Hangzhou Yikefu Technology Co., Ltd. launched a hospital-based3Q Digital Intelligence Clinical Ecosystem Comprehensive Solution, includingHospital-Wide End-to-End eClinical Solutions, Sponsor-Specific End-to-End eClinical Solutions, and Intelligent Middle-Platform Solutions for Integrating Dual Circulation, comprehensively addressing the challenges of collaboration and data silos faced by sponsors, hospitals, CROs, and SMOs.
Figure Note: 3Q Digital Intelligence Clinical Ecosystem Comprehensive Solution
3Q Smart Clinical’s core is its Site eClinical technology. After more than a decade of R&D, optimization, and application, Hangzhou Yikefu Technology Co., Ltd. has delivered industry-highly recognized solutions for the “internal circulation.”Three Types of SolutionsandOver 10 software programs：
GCP SolutionsIncluding software such as GEI and sCTMS, primarily targeting project management, institutional management, and ethics management in the clinical trial process at hospitals,Project implementation management, quality and risk management, and management of project personnel, finances, and resources;
Clinical Phase I / Research Ward SolutionsIncluding software such as PIMS, BEIS, and CWMS, it primarily provides digital clinical trial services for Phase I laboratories and clinical research wards.
Research Case Data SolutionsIncluding software such as sEDC, primarily targeting applications in IIT studies and the automatic generation of eCRFs for registration clinical trials.
Furthermore, Yikefu Hospital's electronic clinical solutions also feature the following characteristics:
Strong compatibility, enabling seamless integration with hospital HIS, LIS, and data middle platforms.All personnel involved in clinical trials at the hospital complete project initiation, ethical review, study implementation, subject management, source data collection and management, quality assurance, and study closure management on a single platform. This approach addresses the issues associated with the widespread use of paper-based and manual processes in traditional hospital clinical research management, significantly enhancing the quality and efficiency of clinical research at the hospital.
Provide standardized, secure, and compliant data interfaces.It provides the foundation for integration with the sponsor’s EDC, CTMS, and other systems, thereby avoiding a series of problems caused by data silos.
Strong technological derivativeness.Leveraging the 3Q electronic clinical solutions, Hangzhou Yikefu Technology Co., Ltd. has developed next-generation CTMS and EDC technologies, known as xCTMS and xEDC respectively. These innovations fundamentally address long-standing industry pain points, such as the need for Clinical Research Coordinators (CRCs) to visit hospitals for data collection and for Clinical Research Associates (CRAs) to conduct on-site Source Data Verification (SDV).
“Establishing an integrated platform for clinical research in hospitals is an inevitable trend. In light of this, Hangzhou Yikefu Technology Co., Ltd. proposed the 3Q Digital Clinical ecosystem solution in 2015, achieving seamless integration between digitalized clinical hospital systems and sponsor systems, thereby addressing long-standing industry challenges. Compared with current solutions in Europe and the United States, our 3Q Digital Clinical solution offers distinct advantages, as demonstrated by multiple clinical trials.”Reduces research cycle by 60% and improves data quality by over 400%”。Lu Min said.
Hangzhou Yikefu Technology Co.,Ltd. has been able to stand firm and achieve steady, long-term growth amidst the industry’s rigorous consolidation, thanks to a seasoned and cohesive management team.
Lu Min, Founder of Yikefu
Founder: Lu Min, holds a Master of Engineering from Zhejiang University and a Master of Science from West Chester University of Pennsylvania. With over 20 years of experience in the United States, he has extensive industrial expertise in drug R&D, GCP management, information technology, and internet technologies. In 2002, he founded ECRFPlus in the United States, providing FDA 21 CFR Part 11-compliant solutions and information technology services to pharmaceutical companies, CROs, Core Labs, and other drug R&D and service organizations in Europe and the United States.
Lu Min is one of the early pioneers in global EDC technology and electronic clinical technology. He has consistently adhered to the "Internet Plus" philosophy, focusing on research into the informatization of clinical trials.Continuously Innovate to Optimize the Company's Products and Development Direction, proposed a series of distinctive digital clinical trial solutions, driving the industry toward electronic and digital transformation.
Yikefu boasts a core leadership team that has been working together for over 10 years, characterized by mature expertise, stable composition, and seamless collaboration. Moreover, all core members possess more than 10 years of experience in the informatization of clinical trials in Chinese hospitals, with proficiency in technologies such as EDC, GCP, eClinical, and digital clinical solutions.
Meanwhile, during his entrepreneurial venture in the United States, Lu Min not only accumulated extensive experience in corporate operations and in serving pharmaceutical companies and CROs in Europe and the United States, but also built a substantial network of renowned overseas clinical research hospitals and expert teams both domestically and internationally. This has laid a solid foundation in terms of both infrastructure and capabilities for the company to launch its innovative “3Q” digital clinical services into domestic and global markets.
After two decades of dedicated efforts, Yikefu hasFudan University Shanghai Cancer Center, West China Hospital of Sichuan University, Beijing Anzhen Hospital, Beijing Children's Hospital, Tsinghua Changgung Hospital, Sun Yat-sen University Cancer Center, Nanjing Drum Tower Hospital, Wuhan Union Hospital, West China School of Stomatology of Sichuan University, Zhejiang Hospitalamong many other Grade A tertiary hospitals, establishing a GCP management platform for clinical trials and an integrated in-hospital clinical research platform, and collaborating withLiangyi Hui, IQVIAestablish strategic partnerships with industrial institutions.
The company has established a framework based on 3Q intelligent clinical technology, coveringHospitals, Sponsors, Regulators, SMOsa series of software technologies and comprehensive solutions. The company’s business model is becoming increasingly mature and is on the verge of entering a harvest phase.
According to Lu Min, the clinical research industry is undergoing a second information technology revolution, characterized by hospitals’ comprehensive adoption of integrated clinical research platforms (based on eClinical) to provide clinical research services to sponsors. This trend mirrors the first technological transformation that occurred in the United States between 2004 and 2008, which was driven by Electronic Data Capture (EDC) technology. This shift will bring about a comprehensive transformation of the CRO service model and foster the emergence of publicly listed companies specializing in electronic clinical information technologies, as well as new types of CROs derived from these technologies.
Building on this foundation, Hangzhou Yikefu Technology Co., Ltd. will solidify its 3Q Digital Intelligence Clinical Overall Solution and collaborate with a cohort of CROs and SMOs,Develop iSMO and iCRO services based on the 3Q solution to provide sponsors with a one-stop service for accelerating clinical research.
Regarding financing, previouslyYikefu Secured Tens of Millions in Strategic Financing Exclusively Invested by Liangyihui。The company has currently launched a new round of financing,for product promotion, talent recruitment, and market education.