Bioknow eClinical Integrated Platform Reduces Drug Development Costs by 40%, Files IPO Prospectus

Drug development is often referred to as the “Valley of Death.” Only one in ten new drugs that enter Phase I clinical trials ultimately receives FDA approval for market launch. The high risk, long development cycles, and substantial costs associated with new drug development represent one of the most significant pain points for pharmaceutical companies, with a considerable portion of time consumed by clinical trials. As innovative pharmaceutical enterprises surge in China and the time lag for the market entry of imported drugs narrows, both pre- and post-launch challenges for new drugs are facing new hurdles.

To address these challenges, the 5th NDAA Innovative Drug Summit was held in Beijing from April 18 to April 19, with the theme “International Challenges.” At the summit, Zhuang Yonglong, CEO of Bioknow, delivered a speech introducing the Bioknow eClinical integrated platform for clinical research. The platform can reduce data cleaning and study management time by 30% and lower overall project costs by 40%.

Integrated research is not merely about converting paper documents into electronic ones to improve efficiency; rather, it leverages informatization, supported by technologies such as AI, natural language processing, and data analytics, to ensure the safety of clinical studies, enhance regulatory compliance in clinical trials, enable early detection of drug safety issues, and comprehensively improve the overall quality of clinical trials.

The digitalization of clinical trials delivers significant cost-effectiveness internally and helps all stakeholders better address external challenges, such as an increasingly stringent regulatory environment.

From the perspective of the external environment, regulatory oversight and requirements have become more stringent. In 2017, China joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), signifying that Chinese drug regulatory authorities, the pharmaceutical industry, and research and development institutions will gradually adopt and implement the highest international technical standards and guidelines. This transition has also posed certain challenges to the management of clinical trials in China.

For pharmaceutical companies, the advent of the precision medicine era has tripled the complexity of clinical trials, as drugs are increasingly targeted at very specific diseases or conditions identified by genetic markers. The journey from laboratory research to new drug market launch involves numerous complex stages, including synthesis and extraction, screening of active compounds, formulation development, quality studies, and preclinical research such as pharmacology and toxicology. This is followed by human clinical trials, regulatory registration and approval, and post-market surveillance. Without the adoption of information technology systems, conducting clinical trials would be virtually impossible.

Inefficiencies and redundancies in clinical trial processes are more severe in China. For example, while the adoption rate of Electronic Data Capture (EDC) systems has reached 90% abroad, it stands at only 30%-40% in China.

Zhuang Yonglong, President of BioKnow, stated, “Clinical trials involve diverse data sources, frequent personnel turnover, and low levels of information sharing, resulting in prolonged implementation cycles and significant operational challenges. However, both internal and external environments now demand standardized implementation, authentic data, and comprehensive documentation for clinical trials.”

Leveraging over a decade of experience in life sciences informatics solutions, BioKnow has targeted this critical pain point by launching four specialized solutions to address the major challenges in clinical trials: clinical data management, project management, document management, and pharmacovigilance. These offerings include the Clinical Data Solution, Project Management Solution, Document Management Solution, and Pharmacovigilance Solution.

Bioknow integrates its four major solutions into a unified clinical research platform (Bioknow eClinical), an information technology product capable of covering the entire clinical trial process, which is rare in the current market.

Regarding the significance of building an integrated platform (Bioknow eClinical), Zhuang Yonglong stated, “As clinical research is a highly specialized engineering endeavor with a high degree of division of labor, enterprises at different stages—due to national regulations and industry development—and driven by project-specific needs, often adopt disparate systems to manage each phase of clinical trials. It is precisely for this reason that the value of the integrated platform (Bioknow eClinical) lies in integrating these diverse systems. It enables progress and cost management across multiple projects, facilitates collaborative workflows among personnel in different regions, and provides a single entry point with single sign-on. This approach reduces redundant data entry, minimizes siloed project management, breaks down information silos, and supports centralized management and enhanced efficiency in clinical research.”

Bioknow has integrated clinical data solutions into its Bioknow eClinical, an integrated cloud platform for clinical research, primarily to address the core issue of poor data quality in clinical trials.

The clinical data solutions comprise four major systems: the Electronic Data Capture (EDC) system, the Medical Intelligent Coding System (Medcoding), the Clinical Data Total Management System (CDTMS), and the Randomization and Trial Supply Management (RTSM) system. Zhuang Yonglong stated, “Clinical data solutions can address issues related to the collection, coding, and management of clinical data.”

In terms of data entry, EDC systems facilitate the transition from paper-based to electronic clinical data entry, addressing issues such as slow data collection and delayed verification. For data coding, intelligent medical coding incorporates multiple pharmaceutical-related dictionaries, including MedDRA, WHODrug, and ICD-10, enabling batch automatic coding and supporting various search methods, thereby resolving the complexities and human errors associated with manual coding.

In terms of data management, the Randomization and Trial Supply Management (RTSM) system supports multi-center enrollment and management, addressing issues such as varying progress across geographically dispersed sites and medication expiration or overstock. This enables investigators at different locations to perform subject enrollment, screening, randomization, drug dispensing, and emergency unblinding at any time.

It is worth noting that Bioknow CDTMS (Clinical Data Total Management System) is an information solution pioneered by Bioknow to address industry pain points in the data management process of clinical trials. Currently, there are no comparable products available either domestically or internationally. Bioknow CDTMS achieves streamlined and standardized management of all tasks within the clinical data management process. By leveraging information from daily system operations, it automatically generates DMP/DMR reports, thereby resolving inefficiencies arising from highly specialized division of labor.

In addition to data management, BioKnow has also launched project management solutions tailored for clinical trials. As the complexity of clinical trial projects continues to increase, high-quality project management is equally critical to their success. Project management in clinical trials primarily encompasses seven key areas: time management, personnel management, financial management, communication management, document management, quality management, and risk management. For clinical trial sponsors, achieving comprehensive coverage and maintaining composure throughout the trial process is no easy feat.

BioAthena’s project management solutions include the Clinical Trial Management System (CTMS), the Online Training and Assessment System (eTraining), and the Image Reading and Slide Shipping Management System for Clinical Trials (PDM). The CTMS enables real-time tracking and monitoring of clinical trial projects. Through graphical interfaces such as budget income/expenditure views, progress Gantt charts, and statistical data charts, project managers can efficiently and rapidly perform tasks related to project management, schedule management, subject management, monitoring management, audit management, supply management, and cost management, while eTraining primarily supports personnel management.

The pain points addressed by PDM lie in the need for offline transport of specimens and random assignment to independent experts for interpretation during clinical trials, with re-adjudication by experts required in case of discrepant results. PDM enables standardization of the entire workflow, real-time monitoring, and randomized blinded distribution.

In Bioknow’s integrated cloud platform for clinical research (Bioknow eClinical), the clinical data solution, project management solution, and document management solution are primarily tool-oriented, aiming to enhance clinical trial efficiency, ensure data security, and maintain process controllability, thereby improving overall quality. In contrast, the pharmacovigilance solution helps R&D professionals identify drug safety issues that are otherwise difficult to detect.

Zhuang Yonglong stated in his speech, “Drug safety is the most critical benchmark and consideration in drug research and utilization. Over the past few decades, confirmed adverse drug reactions have resulted in approximately $75 billion in economic losses and have caused more than 20 million cases of unexpected symptoms annually.”

To reduce the incidence of adverse drug events, a major trend is the transition from on-site monitoring to centralized monitoring. This approach involves conducting trend analyses on data collected via paper Case Report Forms (CRFs) or Electronic Data Capture (EDC) systems to identify risk points and critical data elements in clinical trials. These insights guide sponsors in resource allocation, cost reduction, and efficient study completion.

Within Bioknow’s integrated eClinical platform (Bioknow eClinical), the top three solutions have established data-sharing channels for clinical trials. The Pharmacovigilance (PV) Management System enables mining of existing knowledge bases, spontaneous reporting systems, literature, and active surveillance data. It leverages technologies such as Natural Language Processing (NLP), machine learning, data mining, and the semantic web to perform comprehensive data analysis. Compliant with the latest ICH E2B (R3) standard: “Management of Clinical Safety Data: Data Elements for Transmission of Individual Case Safety Reports,” the system supports Marketing Authorization Holders (MAHs) in collecting, monitoring, researching, assessing, and evaluating drug safety information. It facilitates the establishment of a pharmacovigilance management system and enables electronic submission of individual case safety reports in accordance with national regulatory requirements.

In his speech, Zhuang Yonglong stated, “The integration and mining of drug safety data constitute a complex systems engineering endeavor. The integration of knowledge on adverse drug reactions (ADRs) and the establishment of a knowledge base have further enhanced the value of ADR-related information resources. BioKnow’s PV drug safety database encompasses multidisciplinary content spanning chemistry, biology, basic medicine, clinical medicine, pharmacy, and medical informatics. Its data sources cover information and knowledge from multiple domains, including chemical structures of drugs, drug classifications, pharmacology, pharmacokinetics, drug targets, protein pathways, ADR-associated proteins, and ADR classifications.”

Currently, Bioknow has gained recognition and adoption from 1,000 medium-to-large pharmaceutical companies and CROs in China. Moving forward, Bioknow will continue to empower every stage of the drug and medical device development lifecycle—from R&D to market launch—leveraging its integrated clinical research platform (Bioknow eClinical) and next-generation intelligent pharmaceutical research solutions. This will enhance R&D efficiency and quality, making life science research outcomes more accessible.