EDC Market Welcomes a Groundbreaking New Product: TaiMei HealthTech's eCollect 6 Drives Next-Gen Digital Transformation in China's Clinical Research

Data collection and processing are the core tasks of clinical drug research. The authenticity, accuracy, timeliness, and standardization of data not only affect the quality and efficiency of the study but also directly impact the regulatory submission outcomes and commercialization process of innovative drugs. With the overall improvement of China’s clinical research industry and the growing demand for global expansion of innovative drugs, Electronic Data Capture (EDC) systems have been widely adopted, making electronic data collection a standard requirement for high-quality clinical trials.

In 2022, a cohort of Chinese pharmaceutical companies encountered successive phased setbacks in their FDA approval journeys, reigniting industry concern over controversies surrounding clinical trial data. How to leverage digital technologies to safeguard global expansion has become a critical issue that numerous Chinese innovative drug companies must deeply contemplate, as they navigate the “new normal” of pharmaceutical innovation characterized by greater emphasis on the quality and efficiency of innovation, refined global operations, and compliance with international standards.

As global expansion becomes the norm, what challenges will China’s clinical research industry face? How will digital technologies facilitate the global reach of Chinese innovations? How can data management in clinical research be further enhanced? What new requirements and expectations are stakeholders placing on EDC (Electronic Data Capture) products?

Recently, we had the honor of interviewing Mr. Ma Dong, General Manager of the Clinical Research Business Group and General Manager of the US Company at Taimei Medical Technology. Centered on the theme of “How EDC Products Facilitate High-Quality Innovation in China’s Pharmaceutical Industry Under the ‘New Normal,’” he provided an in-depth analysis of the development history and trends of EDC products.

From 2015 to 2022, China’s pharmaceutical innovation entered a golden age. A series of policies—including the National Major New Drug Development Program, drug regulatory reforms, the Hong Kong Stock Exchange’s Chapter 18A listing rules, and the STAR Market—continuously spurred rapid growth in the innovative capabilities of domestic pharmaceutical companies. The latest data released by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) shows that in 2021, the total number of clinical trials registered in China exceeded 3,000 for the first time, representing a 29.1% increase compared with 2020.

As a critical safeguard for clinical trial data management, the adoption rate of EDC systems has also seen substantial progress in recent years.

“Prior to the ‘722 Incident’ in 2015, the adoption rate of Electronic Data Capture (EDC) systems in China was around 30%, with many companies viewing EDC as a burden. By 2020, this figure had rapidly risen to 70%–80%, and currently, virtually all registered clinical trials in China utilize EDC,” stated Ma Dong. “The adoption rate of EDC is one of the key indicators measuring the development level of the industry, and it is also an essential requirement for Chinese pharmaceutical companies to internationalize and meet global competition.”

He pointed out that clinical study data play a decisive role when truly going global and initiating commercialization. Taking FDA submissions as an example, while the innovativeness of the drug itself and the design of clinical study protocols receive significant attention, verification of data authenticity serves as the baseline for approval—a direction in which the entire industry must strive.

In the first half of 2022, Chinese pharmaceutical companies encountered a series of challenges in their efforts to secure FDA approval. In response, Ma Dong stated that the steps taken by Chinese pharmaceutical companies toward global competition are worthy of encouragement and even admiration. Excellent innovative drugs are destined to serve all humanity and inevitably face global competition. It is essential for more Chinese pharmaceutical enterprises to continuously expand overseas and engage in greater communication and dialogue with the FDA, enabling the agency to understand and recognize the changes occurring in China—a mission for this generation. For Chinese pharmaceutical companies, taking innovative drugs global is no longer merely a competition at the scientific level; rather, it represents a comprehensive benchmarking against international standards, involving an all-around contest of integrated capabilities encompassing technology, management, operations, and services, thereby imposing more comprehensive requirements on these enterprises.

In the specific context of EDC applications, beyond the enduring demand for “high cost-effectiveness” in EDC products, there are new requirements for EDC vendors in terms of international operations, compliance, and service capabilities.

First, given that system costs remain high in internationalized projects, EDC systems must not only address the data challenges and requirements encountered in complex global scenarios but also leverage more advanced technologies to reduce data management costs and time consumption.

Drawing on practical experience and deep insights from thousands of clinical research projects, Taimei has gained a profound understanding of users’ strong demand for next-generation EDC products. In August 2022, Taimei’s flagship annual new product—eCollect 6—is set to be unveiled. Given Taimei’s extensive expertise and widespread adoption in the EDC field, the product has already attracted significant attention even before its official release.

CRF/eCRF design is a core function of EDC systems and one of the most labor- and time-intensive steps in database build. Building on its knowledge base, the new eCollect 6 goes further than competing products by enabling a major shift from manual to automated database build, allowing CRF/eCRF design to be completed within 3–5 minutes and significantly improving build efficiency.

Testing also consumes substantial manpower and time. Statistical data show that testing accounts for approximately 50% of the total database build time, requiring testers to perform extensive manual operations for manual database verification. The new version of eCollect 6 features an automated logic check testing function that automatically generates test cases, creates and populates subject records, and produces result reports; users need only make modifications based on the reports, thereby reducing database build time by approximately one-third.

“Preliminary estimates indicate that automated library preparation and testing can reduce library construction time by approximately 70%–80%, and have demonstrated high reliability in a series of tests, particularly for tumor research,” emphasized Ma Dong. “The new eCollect 6 enables users to achieve higher operational efficiency and lower data management and operational costs, delivering high-quality services to customers with greater cost-effectiveness.”

“Internationalization” is another high-frequency term that Ma Dong repeatedly mentioned during the interview.

“Pharmaceuticals should inherently serve all of humanity rather than any single nation; this intrinsic attribute defines the global competitive landscape of the pharmaceutical industry,” he stated.

In recent years, with the enhancement of R&D capabilities among domestic pharmaceutical companies, “first-in-class” has become a new focal point of competition. Large-scale multinational multi-center studies led by Chinese pharmaceutical enterprises have seen rapid growth, imposing more stringent requirements on the capabilities of Electronic Data Capture (EDC) systems.

In the face of increasingly complex international multi-center clinical trial scenarios, users expect more than just a data collection and management tool; they seek a comprehensive data governance engine that is highly adaptable, feature-rich, secure, compliant, and fully capable of meeting the diverse needs of different countries and users. In this context, what additional support can eCollect 6 provide to innovators expanding into global markets?

Ma Dong revealed that eCollect 6 was designed and developed entirely in English from the outset, rather than following the common “Chinese-to-English translation” approach adopted by many domestic companies. This strategy fundamentally avoids language comprehension issues that may arise during translation, offering greater user-friendliness for international users. Its robust multilingual support capabilities also enable eCollect 6 to facilitate seamless cross-border and even intercontinental collaboration.

For complex international project scenarios, eCollect 6 features advanced adaptive design and enhanced custom programming capabilities. Its more powerful data migration functionality significantly simplifies the migration process, reduces migration time, and mitigates potential risks. Furthermore, the system fully meets the diverse requirements of international multicenter studies across different countries, time zones, languages, user interaction preferences, data analysis, data extraction, and data storage, thereby ensuring the smooth conduct of research.

Meanwhile, eCollect 6 continues to refine its details extensively. In terms of functionality, it boasts numerous advanced designs, such as custom functions that enable more complex data management, a task manager that automates task volume statistics, NEXT QUERY that significantly reduces the time required for query management operations, and an integrated authorization platform that lowers management costs. Furthermore, its pervasive user-friendly design substantially reduces training and usage costs for users.

In international projects, platform-based data connectivity will also be another important trend for EDC. As the primary source of clinical research data, EDC systems need to possess enhanced data transmission capabilities to enable seamless data exchange with CTMS, PV, and drug randomization systems, thereby becoming a central hub for data management.

In recent years, countries in Europe and the United States have strengthened data security supervision, with relevant regulations continuously updated. This change has become a source of concern for many Chinese pharmaceutical companies, and the new version of eCollect 6 is well-prepared for this.

“While fully complying with the regulatory requirements of various countries, eCollect 6 has pioneered independent deployment across different global regions. Through our partnership with Amazon, we have already achieved multi-location deployment within the United States. In the future, we will deploy additional local servers in Europe, Singapore, and other regions to meet the regulatory demands of different countries,” he emphasized.

Meanwhile, localized teams have also become a guarantee of eCollect 6’s global high-quality service capabilities. Currently, Taimei has established local teams in multiple regions, including the United States and Singapore, to provide high-quality services to global customers with faster response times and more efficient communication.

In recent years, Taimei Medical Technology has continuously achieved breakthroughs in the SaaS sector for pharmaceutical R&D. Data shows that its independently developed TrialOS Pharmaceutical R&D Collaboration Platform currently provides digital solutions to over 1,100 pharmaceutical companies/CROs and more than 660 clinical trial institutions. Between 2018 and 2020, it supported the R&D and market launch of approximately 40% of China’s Class 1 new drugs, having become a significant force driving the high-quality development of pharmaceutical innovation in China.

This time, eCollect 6 will engage in direct competition with global giants in medical informatics on a worldwide scale. As a Chinese manufacturer, what is the source of eCollect 6’s confidence in competing on the “home turf” of these international industry leaders?

“Competing alongside international giants, our confidence stems primarily from the robust capabilities of our products. Taimei’s EDC product has undergone nearly eight years of market validation and has been highly acclaimed by numerous clients, with its product quality and brand influence widely recognized. We are confident in meeting the rigorous demands of the most professional, advanced, and leading clients worldwide,” said Ma Dong.

Meanwhile, Ma Dong also revealed that Taimei Medical Technology, as the only EDC vendor in the industry with a dedicated customer success team, maintains close communication with its clients, proactively identifies their needs, and provides cost-effective, personalized services tailored to enterprises at different stages of development. This approach truly embodies being “customer-centric” and fosters mutual growth with clients.

As a vital component of its corporate mission—“Making Quality Medicines Accessible”—internationalization is Taimei Medical Technology’s unwavering long-term strategy. Guided by this conviction, Taimei Medical Technology remains dedicated to developing digital technologies for clinical research, building the infrastructure that underpins the pharmaceutical industry’s operations. This enables faster market access for new drugs, ensures patient medication safety, facilitates access to quality medicines, serves industry prosperity, and strives to safeguard public health.

Taimei looks forward to joining hands with more partners to create a brilliant future!