How Digital Solutions Enable Cost Reduction and Efficiency Enhancement in Clinical Research Amid Rising Drug Submissions and Tightened Investment

With the continuous development of the biopharmaceutical industry, innovative drug R&D has entered a period of rapid growth, and the number of clinical trials is on the rise. Consequently, improving clinical trial efficiency while reducing the costs and risks associated with clinical research has become an urgent need for an increasing number of pharmaceutical companies and research institutions.

Leveraging digital tools to drive the intelligent and data-driven development of clinical trials is undoubtedly an inevitable trend.

To better meet the demands of clinical digital-intelligent development and share the latest achievements and solutions in this field, Yilinyun recently hosted its inaugural user conference in Chengdu, themed “Digital-Intelligent Empowerment · Symbiosis and Win-Win.” The event gathered industry leaders from the pharmaceutical and healthcare sectors for in-depth discussions.

Amid tightening investment in the pharmaceutical industry and a rising number of new drug clinical trials, pharmaceutical companies urgently need digital solutions to reduce clinical research costs and improve clinical trial efficiency.

Dr. Qin Long, Founder and CEO of Yilin Cloud, shared that patient-centric clinical trials and decentralized clinical trials are becoming a new trend.

Yi Lin Yun has made three major strategic deployments in response to this trend: an integrated interoperability platform, endpoint assessment solutions, and technological intelligence and innovation.

Yi Lin Yun provides a one-stop solution for the full lifecycle of clinical trials through its integrated interoperability platform.Currently, its integrated cloud platform is highly mature, having been utilized in multi-center clinical trials across numerous countries worldwide and applied in multiple international Phase III clinical studies.

Yi Lin Yun’s clinical endpoint assessment solutions have covered various therapeutic areas, including central nervous system disorders, ophthalmology, oncology, cardiovascular diseases, and dermatology, accumulating extensive experience in scale management and rater training.Its eCOA system embodies the patient-centric philosophy of clinical research, enhancing patient compliance while enabling more scientifically rigorous evaluation of clinical efficacy.

Currently, Yilin Cloud has partnered with Microsoft to empower its entire product line with AI, and has already deployed an AI-powered intelligent assistant based on natural language models.

Notably,At its inaugural user conference, Yilin Cloud unveiled the all-new ECC ONE, which migrates operations previously requiring a PC to mobile devices, further enhancing the efficiency of data transmission and document or workflow approvals.

Over the past three years, Yilinyun has established partnerships with nearly 100 clients, collaborating with more than 800 clinical trial centers (covering virtually all currently active centers) and enrolling over 30,000 subjects. The platform operates in more than 10 countries and regions, managing over 500 clinical trial projects.

Achieving these capabilities is attributable to Yilin Cloud’s robust product research and development innovation.

According to Wu Weiping, Chief Technology Officer of Yilin Cloud, “Products that meet the needs of medical users, R&D system architecture, and innovation interact closely with one another, jointly facilitating the company’s support in achieving the goals of clinical research management.”

In terms of products, Yilin Cloud has developed the ECC Integrated Clinical Trial System. In clinical trials, the involvement of multiple organizations and roles often leads to information silos and inefficient communication; furthermore, lack of data interoperability between isolated systems frequently results in transcription errors, data loss, and redundant work. Committed to “digitally transforming clinical research,” Yilin Cloud leverages an integrated, interconnected platform,Integrate systems such as CTMS, eTMF, eCOA, EDC, RTSM, RM, and eLearning into a unified platform, achieving interoperability through advanced infrastructure. Users can access and operate all subsystems with a single set of login credentials. Furthermore, the entire platform enables the industry’s fastest deployment via a “zero-code” approach.

In terms of innovation, Yilinyun has established the ECC Innovation Center and is currently further empowering clinical trials through AI. Wu Weiping pointed out that Yilinyun has achieved a leading position in China for its own systems and is actively advancing towards intelligent solutions.

How Does Yilin Cloud’s Digital Clinical Trial Solution Empower Innovative R&D for Domestic Pharmaceutical Companies?

Perhaps two examples can better illustrate this.

First, Yilin Cloud facilitated the approval and market launch of Leretrevir Tablets, the world’s first novel Class 1 antiviral drug against SARS-CoV-2 featuring a peptidomimetic 3CL protease inhibitor as monotherapy.

Dr. Chen Xiaoxin, Co-founder of Raynovent Therapeutics, shared that the company initiated the project upon recognizing that COVID-19 infection might become a seasonal endemic disease. Raynovent selected the optimal target for oral antiviral drugs against SARS-CoV-2 and fully advanced the development of a 3CL protease inhibitor, aiming to meet the need of high-risk populations for monotherapy with a low risk of drug-drug interactions (DDI). Ultimately, Raynovent completed the new drug development in less than one year, during which its team overcame various challenges posed by the pandemic.

Yi Lin Yun’s eCOA system also played a pivotal role, enabling Zhongsheng Ruichuang to seamlessly pass the CFDI inspection. It not only ensured data integrity, accuracy, and real-time availability but also helped Zhongsheng Ruichuang obtain reliable clinical trial endpoint data, which gained recognition from the NMPA inspection experts.

Secondly, Yilin Cloud empowers CMSK Biopharma’s innovative R&D.

CMS Biopharma is currently advancing its innovation-driven transformation and implementation, with a portfolio of multiple First-in-Class (FIC) and Best-in-Class (BIC) innovative products. Yin Yuanyuan, Deputy General Manager of CMS Biopharma, pointed out that clinical trial management often faces numerous challenges, such as complex processes, multiple stakeholders, large data volumes, cumbersome documentation, prolonged timelines, and unpredictable risks. Drawing on his personal experience, he emphasized the importance of digital empowerment in clinical research, noting that the eTMF system ensures document integrity while facilitating audits, and the eCOA system guarantees data integrity, accuracy, and compliance, thereby enabling more efficient analysis.

Meanwhile, the leadership of CMS Biopharma has also recognized the importance of post-investment management in enhancing the success rate of clinical trials. To this end, CMS Biopharma has partnered with Yilinyun to establish its own post-investment management system through a comprehensive digital solution, transforming the traditional model of “people seeking tasks” into one where “tasks seek people.” Under this new system, each role receives daily work assignments and deadline reminders, significantly improving management efficiency.

What Challenges Remain in Leveraging Digitalization to Support Clinical Research?

The on-site roundtable forum invited Guoxin Medicine CEO Song Wei, Noxegel Co-founder Wang Wei, Zhongsheng Ruichuang Co-founder Chen Xiaoxin, Kangzhe Biology Deputy General Manager Yin Yuanyuan, Pharmaron Clinical Chief Business Officer Xu Hui, and Susu Technology CEO Lü Ning to engage in discussions.

Addressing the most pressing concerns of numerous pharmaceutical and CRO companies regarding how to enhance clinical trial efficiency and success rates, Wang Wei from Noxell and Xu Hui from Pharmaron both pointed out that, amid the slowing growth in the number of new drug IND applications and declining costs per project, it is essential to further embrace innovative tools such as digital systems. This approach enables streamlined management, data interoperability, and human-machine interaction, thereby improving managerial efficiency.

Cost reduction and efficiency enhancement are pain points that many enterprises seek to address. However, Yin Yuanyuan from CMSK Biopharmaceuticals points out that greater emphasis should be placed on achieving higher value with equivalent investment, focusing on the quality and success rate of clinical trials rather than merely on price levels.

Numerous challenges are also being encountered in the current advancement of eCOA. Xu Hui from Pharmaron Clinical pointed out that the greatest challenge lies in its low adoption rate, but early planning is still essential. Chen Xiaoxin from Zhongsheng Ruichuang stated that attention should also be paid to improving the usability of eCOA for elderly patients and better addressing issues related to patient data entry.

Ultimately, patients, researchers, and other stakeholders will all benefit from digital solutions for clinical research management.

Participants noted that although clinical research management still faces certain challenges, digital solutions will ultimately empower the field to achieve a qualitative leap, thereby benefiting all stakeholders across the industry value chain.