A New Chapter in the EDC Market Battle: How Informatics Companies Are Capturing Evolving Client Needs
Electronic Data Capture (EDC) systems for clinical trials were developed to address the non-standardization and inefficiencies associated with various clinical trial data standards. Compared to the traditional method of collecting paper-based case report forms (CRFs) and manually re-entering the data, EDC systems are simpler and faster, significantly reducing workload and quality risks while shortening study duration. This approach improves data quality while lowering costs. In different studies, the use of EDC systems has been shown to reduce research costs by 49%–62% compared to paper-based data collection processes.
Driven by numerous advantages, EDC systems have long been widely adopted overseas. In contrast, the adoption of EDC systems by Chinese pharmaceutical companies started relatively late, with their development primarily driven by policy initiatives. Although there is now a considerable number of domestically produced EDC products, few are capable of competing with well-established international brands.
So, after years of iteration, where does the EDC system stand today? VCBeat interviewed Ma Dong, General Manager of the Clinical Research Division at Taimei Medical Technology, to explore how EDC has evolved over the past few years.
Since 2014, China’s EDC market has begun to emerge. The “722 Incident” in 2015 spurred the entire clinical research informatics industry, with EDC being one of the most visibly benefited products. Following the data verification campaign, industry-wide awareness of data collection management and digitalization reached a level of widespread adoption. This shift in understanding subsequently drove a transformation in the market landscape, leading to a rapid and significant increase in EDC adoption rates. After four years of explosive growth in the EDC market, the current market structure has matured and stabilized. Taimei Medical Technology’s eCollect®, Medidata Rave, and Oracle Inform form a triopoly, collectively capturing 80% of China’s EDC market. Cube, Viedoc, and BioKnow constitute the second tier, competing with other small tech companies’ EDC products for the remaining market share.
At the same time, the composition of customer types is also undergoing changes. Ma Dong stated, “Looking at the customer structure of Taimei eCollect from early 2018 to early 2019, we found that the proportion of innovative drug company customers increased significantly, rising from 15% in the past to over 40%. This reflects an industry trend in China’s pharmaceutical sector—shifting from traditional generic drugs to innovative drugs.”
Given the current widespread understanding of Electronic Data Capture (EDC) systems, enterprises of different types have varying focal points regarding EDC. For emerging biotech companies and large pharmaceutical firms primarily focused on innovative drugs, in addition to requirements for comprehensive functionality and system stability, attention is also paid to whether the EDC system can meet the informatics needs of specific application scenarios across the entire business chain. These include data transmission between EDC and Clinical Trial Management Systems (CTMS) or Pharmacovigilance (PV) systems, capabilities for data migration in large-scale studies, customized data export functions, and the product’s capacity for continuous updates. In contrast, for pharmaceutical companies primarily engaged in Bioequivalence (BE) studies or early-phase clinical trials, product stability and low cost are the primary criteria for selecting an EDC solution.
It can be said that under the strong impact of Taimei’s eCollect, overseas EDC products have significantly reduced their prices over the past two years, with price cuts ranging from 30% to 50%. In the price war against foreign-funded EDC providers, Taimei Medical Technology has maintained strong competitiveness and sufficient resilience, continuously increasing its annual investment in EDC products. In 2018 alone, Taimei invested over RMB 20 million in its EDC product to ensure continuous improvement in various aspects of product capability, including system stability, adaptability to special scenarios, data security, and value enhancement, thereby guaranteeing an excellent user experience. Since the upgrade of eCollect to its fifth generation, it has been validated in nearly 400 projects. It has demonstrated outstanding performance in terms of system smoothness, user-friendliness, and data security, earning cooperation and recognition from a large number of innovative pharmaceutical companies.
How to Respond to the Complex and Deep-Seated Needs of Enterprises and the Market? According to reporters, Taimei Medical Technology’s solution is to closely monitor customer needs and changes in clinical research models, while solidifying the foundational infrastructure of its products and adopting new technologies and innovative solutions.
Ma Dong stated, “Clinical trial design is becoming increasingly complex and flexible, leading to subtle changes in usage scenarios. For instance, data collection plans are continuously adjusted throughout the trial, inevitably resulting in more Case Report Form (CRF) changes. When such changes occur, pharmaceutical companies require systems that provide robust support for data migration. The ability to effectively perform data migration will become a critical criterion for evaluating Electronic Data Capture (EDC) products. Meanwhile, requirements for data migration are becoming more refined, including handling data additions, deletions, and modifications; executing old and new logic checks; automatic error correction for eCRF modifications; and simulated data migration, all of which impose new demands on EDC systems. Furthermore, based on the usage of Taimei’s EDC system, the frequency of data migration per project has been increasing annually. In 2018 alone, the Taimei eCollect system performed over 5,000 data migrations.”
In April 2018, Taimei released eCollect V (the fifth generation of its EDC product), aiming to enhance the stability and scalability of eCollect. The most significant technical change in eCollect V lies in its underlying refactoring, replacing .NET with Java. At the application level, eCollect V focuses on implementing advanced technologies in practical scenarios. For instance, by encapsulating more functions and enabling more precise data point acquisition, it allows for the simpler implementation of complex logical checks. In assessing the association between concomitant medications and adverse events, artificial intelligence is introduced to support decision-making, assisting data management tasks, reducing manual verification time for data managers, and improving accuracy. On the data collection side, OCR technology has been developed to automatically recognize laboratory test reports, thereby improving data collection efficiency. Additionally, automated medical coding has been implemented to enhance coding efficiency, among other improvements.
From a vertical perspective, competition in the EDC sector will inevitably converge on enhanced specialization and the ability to accommodate a wider array of personalized scenarios. Horizontally, EDC systems are likely to assume the function of specialized project databases in the future.
Ma Dong stated, “Risk management based on the EDC system will be a crucial aspect of the value upgrade for Taimei’s EDC.” Since its inception, Taimei Medical Technology has made its most significant contribution to the industry by implementing many ideas that existed only in the minds of industry professionals but had never been realized. These include key systems and solutions such as EDC, CTMS, eTMF, central imaging, and PV, which have substantially reduced the difficulty and cost of clinical trial execution, providing a robust informatics infrastructure for the substantial development of the pharmaceutical industry. The next goal for Taimei is to establish a risk-based quality management system.
In 2018, China released the draft for public comment of the new Good Clinical Practice (GCP) guidelines and joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). At that time, both Chinese GCP and ICH-GCP recommended, or even required, sponsors to adopt risk-based quality control measures for clinical trials. However, to date, the vast majority of sponsors have not established a truly risk-based quality control system. This is because every aspect—from risk definition, assessment, monitoring, and analysis to implementing corrective actions—relies on support from information technology systems; without such support, the entire quality control framework would be too inefficient to implement. Ma Dong stated that Electronic Data Capture (EDC), as a natural source of data, can provide the best solution for clinical data risk analysis at the project level. When integrated with Interactive Web Response Systems (IWRS), Clinical Trial Management Systems (CTMS), and electronic Trial Master Files (eTMF), it can form a fairly comprehensive risk management solution. According to Ma Dong, the EDC-based risk management solution will be officially launched in mid-September 2019.
On April 4, 2019, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved a supplemental application for a new indication of Ibrance (palbociclib), in combination with an aromatase inhibitor or fulvestrant, for the treatment of male patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. This marked the first time the FDA approved a supplemental indication based on real-world medication data. Domestic policies quickly followed suit. On May 29 of the same year, the Center for Drug Evaluation (CDE) released a draft guidance titled “Basic Considerations for Using Real-World Evidence to Support Drug Development,” aimed at evaluating drug efficacy and safety. This was the first instance in which official documents explicitly mentioned the use of real-world evidence in clinical research.
Over the past five years, Chinese pharmaceutical companies have gradually placed greater emphasis on and conducted extensive post-marketing studies. Unfortunately, however, the vast majority of these companies have not standardized, cleaned, or consolidated the data generated from such studies. In contrast, global pharmaceutical giants like Pfizer invest substantial funds annually to standardize clinical study data, both pre- and post-marketing. They conduct comprehensive analyses covering product safety, off-label use, new dosing regimens, and efficacy across different disease subtypes, thereby maximizing product value and extending lifecycle longevity. Viagra and palbociclib serve as typical examples of this approach. Based on this, Ma Dong believes that Electronic Data Capture (EDC) systems can be further extended to function as enterprise-level data repositories (EDR) for pharmaceutical companies, providing stronger data support for future real-world studies. It is reported that Taimei has already begun assisting some companies in establishing EDC-based enterprise data repositories.
China is at a critical juncture in the upgrading of its pharmaceutical industry. The rise of certain innovative drug companies has validated the phased achievements of this industrial transformation, yet the road ahead remains long. Whether driven by national data security concerns or the urgent need to reduce costs and enhance efficiency in new drug R&D, China requires enterprises like Taimei Medical Technology to solidly provide informational infrastructure for the industry, acting as the “infrastructure powerhouse” of the pharmaceutical sector. Taimei’s performance has lived up to its mission: making quality medicines accessible to all. It is an entity worthy of our anticipation.