Bioknow's 15-Year Digital Transformation in Clinical Research: Breaking Barriers and Building an AI-Driven Lifecycle Platform

With the advancement of AI and big data technologies, the application of innovative technologies has become an effective approach to overcoming bottlenecks in the informatization of clinical drug development, making intelligent clinical research an inevitable trend.

As a critical link in the biomedical R&D industry chain, clinical research digitalization has witnessed significant growth over the past two years. On the international front, Veeva and Medidata have emerged as industry giants, while startups such as Science 37 are catching up rapidly with their unique technological advantages.

In China, a wave of emerging providers of digital products and solutions for clinical research has also arisen, seeking breakthroughs within the industry. Along this developmental path, numerous startups founded around 2015 are on the rise. By contrast, Biocore, as a seasoned enterprise with 15 years of experience exploring digitalization in the pharmaceutical industry, is well-positioned to elucidate the industry’s development trends.

The importance of digitalization for pharmaceutical companies’ clinical trials is self-evident. By leveraging digital tools, pharmaceutical companies can enhance the accuracy, safety, and efficiency of clinical trials, ultimately achieving a win-win outcome for multiple stakeholders, including patients, pharmaceutical companies, and clinical trial institutions.From a single IT solutions provider to a professional clinical research SaaS company, Beijing BioKnow, founded in 2007, has carved out its own development path with data at its core.

“At our inception, we were committed to providing informatics and data analytics solutions for the biopharmaceutical sector. At that time, domestic pharmaceutical R&D was predominantly paper-based, with no significant demands for digitalization.” Recalling the early days of BioKnow, Dr. Zhuang Yonglong, Founder and Chairman, stated. However, a turning point in its development emerged in 2015.

2015 marked the inaugural year of clinical research compliance for China’s pharmaceutical industry. The issuance of the “Announcement on Launching Self-Inspection and Verification of Drug Clinical Trial Data” propelled pharmaceutical companies involved in 1,622 registered drug applications to the forefront of the wave of reforms in drug registration review and approval. Untruthful, non-compliant, and incomplete clinical trial data severely hindered the healthy development of pharmaceutical R&D. Amidst this turmoil, China’s domestic pharmaceutical industry faced large-scale restructuring and reshuffling, with numerous pharmaceutical companies, clinical trial institutions, and CROs suffering significant impacts and heavy losses. Nevertheless, it was also in this year that the National Medical Products Administration (NMPA) steered China’s drug registration system onto a sound developmental trajectory, laying the foundation for the future flourishing and diversification of the Chinese pharmaceutical industry.

Not a few companies have seized policy opportunities to achieve transformation and development, with BioKnow becoming one of them by leveraging its data advantages as an entry point. “Following the ‘July 22 Announcement’ in 2015, the digitalization of clinical research became an imperative need for pharmaceutical companies. We took this opportunity to decisively shift our corporate focus toward the digitalization of new drug clinical research.” Since 2015, as Chinese government agencies have intensively issued policies related to clinical research on innovative drugs, BioKnow decided to divest businesses unrelated to the informatization of clinical trials. Through this “business streamlining,” it has become one of the earliest companies in China specializing in the digitalization of clinical research for innovative drugs.

In addition to divesting certain business lines, BioKnow has also expanded its service offerings under policy incentives to strengthen its competitive position in the industry. In 2018, China began gradually implementing laws and regulations related to real-world studies (RWS) to accelerate the review and approval of pharmaceutical and medical device products. BioKnow responded proactively by launching MedAI, an intelligent medical research platform that complemented the company’s strategic direction in real-world studies. By leveraging digital technologies to enable comprehensive, all-scenario post-marketing real-world studies for drugs, BioKnow successfully transformed itself into a clinical research SaaS company.

To date, BioKnow has completed two key strategic adjustments in 2015 and 2018, achieving a leap in its own development through the “selection” and “abandonment” of business lines. More critically,BioKnow has accumulated a rich portfolio of intellectual property and obtained comprehensive domestic and international regulatory certifications. Two pivotal strategic decisions, coupled with years of refined development, have enabled BioKnow to establish a core value system centered on “Informatics + AI + Big Data” and to build an industrial digital platform covering the full lifecycle of clinical research for innovative drugs and medical devices.

Currently, the three major business types in clinical research include clinical development of innovative drugs, post-marketing drug management, and investigator-initiated trials (IIT). Dr. Zhuang Yonglong noted, “International digital clinical research enterprises basically cover all the aforementioned business areas, with key players including Medidata, Veeva, Oracle, and IBM. In China, apart from Taimei Technology and our company, many startups focus on single scenarios or combine multiple business lines to capture a larger market share.”

In the current landscape of this sector, BioKnow has established a development strategy specifically tailored to enterprise-side services, building up its capabilities through comprehensive coverage of three major business areas.eClinical and MedAI: Two Core Technology Platforms, providing enterprises with one-stop IT solutions.

eClinical is a digital cloud platform for clinical research on innovative drugs, addressing compliance issues and accelerating regulatory approval and market launch through full-lifecycle digitalization and integration of new drug development.

Currently, the informatization of new drug clinical development faces numerous challenges. Due to stringent regulatory requirements, a large number of users, highly specialized division of labor in clinical research, and complex workflows, a single clinical research project often requires the use of multiple disparate information systems. However, the lack of interoperability among these systems frequently results in data silos, leading to significant redundant work, severely impairing data utilization efficiency, and hindering big data mining. Even when employing relatively mature foreign information systems, integration is often poorly implemented due to various factors, resulting in inefficient interconnectivity between systems. Consequently, data integration relies more heavily on manual processes outside the systems or the establishment of larger data warehouses.

To help enterprises address the aforementioned challenges, BioKnow’s eClinical platform empowers the entire clinical research process with a focus on compliance and efficiency. Currently, eClinical has established an integrated system platform covering protocol design, project management, document management, data capture, randomization, medical coding, patient-reported outcomes, image reading, drug safety, and regulatory submissions. Aligned with the workflows and modules of drug development, it achieves integration and comprehensive coverage.

By establishing this platform, eClinical not onlyAchieved unified management of user accounts under an integrated framework., achieving one user, one account, and one login portal,It also achieved interconnectivity between project information and data.More importantly, in addition to the holistic management of the project,eClinical enables personnel management within the organization, significantly improving work efficiency and quality.In light of this, Dr. Zhuang Yonglong stated: “When all clinical study data and information are stored under eClinical, users can also utilize visualization tools to present various aspects of clinical studies in real time for the management of clinical research projects.”

Leveraging these digital tools, BioA’s eClinical platform not only drives the improvement and innovation of drug lifecycle management through in-depth data mining and scenario-based visualization, but also achieves data unification and sharing, thereby reducing labor input. This platform empowers enterprises with the ability to uncover data value, breaks down data and information silos, builds corporate data assets, and extends the lifecycle of pharmaceutical products.

If eClinical addresses the pain points and challenges in the innovative drug development process, MedAI focuses on “real-world studies” to solve the digitalization challenges in post-marketing drug research management, thereby addressing clients’ cost concerns.

Conventional clinical studies rely heavily on extensive manual labor. However, for Real-World Studies (RWS), which involve large volumes of data and multiple centers, relying primarily on manpower proves inefficient. Meanwhile, most current databases focus predominantly on data collection and management, with few integrated platforms that combine data collection, governance, and analysis. Consequently, when researchers urgently need study data as material, they often fail to obtain timely analytical results due to delays in data processing. In this context, highly advanced digital clinical trial solutions have become a crucial enabler for conducting RWS and represent a key upstream segment of the RWS industry.

In addition to the need to optimize labor costs, the collection of real-world data faces numerous challenges, including inconsistent data quality, discrepancies in data coding, and difficulties in collecting data outside hospital settings. Meanwhile, the large sample sizes and high data heterogeneity inherent in such studies impose more stringent requirements on statistical methods. The costs associated with data structuring and analysis have become the primary obstacle for pharmaceutical companies conducting real-world studies.

Distinct from traditional data acquisition and operational models,MedAI, driven by AI technology, processes and governs massive volumes of medical data, intelligently extracts applicable data from real-world clinical scenarios, and generates structured datasets for intelligent analysis, thereby enabling the rapid generation of results for Real-World Studies (RWS) and Investigator-Initiated Trials (IIT).

This innovative RWS service,MedAI has established its core competitive advantages in the areas of data acquisition, data structuring, follow-up, and statistical data analysis.In terms of data acquisition and structured processing, MedAI utilizes state-of-the-art OCR technology to recognize text within images, and employs AI technologies such as NLP and machine learning to structure the extracted text. For follow-up visits, intelligent data conversion is achieved through speech recognition.

In terms of statistical data analysis, MedAI offers three intelligent analytical tools: Cloud Statistics, an Analysis Model Library, and Standardized Analysis Workflows. Leveraging these capabilities, MedAI provides a variety of analysis models and literature-based case models relevant to drug development. These analytical models can be integrated with the data processing module, allowing users to define data extraction parameters based on sample datasets. This enables real-time, one-click data analysis concurrent with data collection on the platform, helping researchers monitor project data status and visualize results at any time, thereby facilitating the dynamic implementation of research projects. Furthermore, MedAI accurately extracts real-world patient and pharmaceutical data to construct patient profiles and a research knowledge base. Operating within an integrated cloud platform for real-world study (RWS) powered by cloud services, it assists clinical researchers in achieving intelligent patient recruitment and risk-based remote monitoring.

With the support of the above core advantages,MedAI can significantly reduce the costs of data collection and project operations in real-world studies, thereby improving the efficiency of research output.For instance, in converting real-world data (RWD) into real-world evidence (RWE), MedAI can reduce total CRO service costs by 60%, with data collection costs decreased by 50% and inspection costs reduced by 70%.

By leveraging its two core technology platforms, eClinical and MedAI, Bioknow has established robust technical barriers in terms of both breadth and depth. The eClinical platform’s comprehensive coverage of scenarios, modules, and processes has enabled Bioknow to achieve broad industry deployment, while MedAI, centered on big data and AI, has driven deep digital innovation and application.

After 15 years of development, BioKnow has established a mature market operation strategy, advancing product commercialization through dual channels in industry and academia.

In terms of industry operations, BioKnow adopts a SaaS-based model to ensure the standardization of its products and services, thereby enabling rapid commercial replication. In addition to providing product applications, BioKnow offers value-added services centered on real-world evidence (RWE) for post-marketing research projects to pharmaceutical companies, which strongly enhances customer stickiness.

In the academic sphere, BioKnow has established a strategic partnership with the Biomedical Big Data Professional Committee of the Chinese Society of Biotechnology. Currently, the Committee has invited six academicians to serve as Honorary Chairmen and collaborates with clinical experts, bioinformaticians, data governance specialists, and health economics experts to jointly establish 20 disease-specific academic groups. This initiative aims to fully leverage their academic influence in the future in areas such as data collection, cleaning, governance, analysis, statistics, security, application of results, and value translation for innovative drugs and pharmaceutical research in China.

Under this operational strategy, BioKnow has not only expanded its market presence but also gained widespread recognition from customers.Currently, BioKnow has served more than 1,000 domestic and international innovative drug and medical device R&D enterprises and CRO companies, including major pharmaceutical companies such as Hengrui Medicine, Sinopharm Group, AstraZeneca, and Pfizer.Among these large pharmaceutical companies, Hengrui Medicine has long been a client of BioKnow. Since their collaboration began in 2014, Hengrui Medicine has adopted BioKnow’s Electronic Data Capture (EDC) system, Medical Coding system (MedCoding), and Clinical Data Total Management System (CDTMS) across multiple drug clinical trial phases. To date, the two companies have engaged in deep cooperation on nearly 200 projects.

Additionally,BioKnow has also empowered more than 3,000 clinical research projects, facilitating the regulatory approval and market launch of new drugs and medical devices.Meanwhile, supported by its project-based pricing model, BioKnow’s SaaS renewal rate has exceeded 80%, ensuring that its flagship products—EDC, RTSM, PV, and eTMF—maintain a leading market share across China. Its products have earned sustained customer adoption due to their compliance, stability, and professionalism.

Nevertheless, the development of our core platforms continues. Dr. Zhuang Yonglong has high expectations for the company’s two key technology platforms: “Since we began focusing on innovative drug R&D in 2016, our eClinical technology is more mature and holds a slightly higher market share. In contrast, MedAI was launched only after the successive release of policies on real-world studies, which meant its R&D started relatively later. As this business line was just introduced last year, it remains in the development stage, and we need to continually refine and improve it.”

Currently, competition in China’s clinical research digitalization sector is intensifying. Dr. Zhuang Yonglong believes that price wars are likely unavoidable: “As many pharmaceutical companies’ products gain inclusion in the National Reimbursement Drug List (NRDL), these companies are also increasing their investments in compliant marketing. These developments may lead enterprises to place greater emphasis on cost considerations. From a trend perspective, reducing prices to secure NRDL inclusion has become an essential pathway for product commercialization, while the scope for compliant marketing strategies is narrowing. Therefore, driven by the need for cost control among pharmaceutical companies, upstream providers of clinical research digitalization solutions must also engage in price wars when necessary to maintain their competitive advantage.”

Beyond price wars, some digital drug R&D companies have chosen to cope with intense competition by expanding their business operations, such as scaling up their clinical research teams. However, BioKnow believes that business expansion is a double-edged sword and not the only way to break through the competitive deadlock.Data, as the core of BioKnow’s development, has always been the foundation of its position in the industry. In the future, BioKnow still hopes to leverage the power of data to refine and specialize in platforms, services, operations, and value enhancement, thereby building its own differentiated advantages.

In addressing the challenge of involution, BioKnow has identified a third path beyond price wars and business expansion.

Currently, BioKnow has launched a new round of exploration and expansion, with specialized disease areas and digital therapeutics as its breakthrough points.In disease-specific fields, BioKnow’s integrated research platform facilitates the digital operation of clinician-initiated clinical studies and establishes a unified clinical big data system. This helps address the unmet needs of clinicians for clinical data, promotes patient-centered precision therapy, and accelerates the translation of innovative medical research findings.

Beyond pushing digitalization and informatization to their limits,In response to the growing trend of Chinese innovative pharmaceutical companies expanding overseas, BioKnow has also introduced its internationalization strategy.Currently, Chinese clinical research digitalization enterprises are not lagging behind their international counterparts in terms of technology; however, they do face certain disadvantages in product internationalization. To address this disadvantage,BioKnow has proposed a two-step solution: First, to achieve product internationalization, BioKnow will leverage talent support to further deepen the integration of its products with international regulatory policies. Second, building on this foundation of product internationalization, BioKnow is committed to becoming the strongest partner for Chinese innovative pharmaceutical companies in their global expansion, empowering the overseas rollout of China’s innovative drugs by providing localized enterprises with international-grade products and services.

The development of China’s innovative drug industry is filled with both promise and challenges. BioKnow will deepen its digital transformation by building an international intelligent platform for pharmaceutical research and precision medicine informatics powered by AI, thereby enhancing research efficiency and the translation of scientific achievements into clinical applications, and ultimately advancing the cause of healthcare.