Digital Transformation in Clinical Trials: Enhancing Efficiency and Order through Technology

Since 2015, the intensive rollout of healthcare reform policies has compressed drug profit margins and further narrowed corporate profits, driving companies to implement cost control across all operational links. As a result, digital technologies have become an inevitable choice for pharmaceutical enterprises to achieve sustainable development, with applications spanning drug research and development, manufacturing, and sales.

Amid the wave of digital transformation, pharmaceutical companies are reshaping their core competitiveness. Specifically in the clinical trial sector, digital technologies are widely recognized as the solution to address the persistent challenges of high costs and low efficiency in clinical trials.

In November 2021, the Center for Drug Evaluation (CDE) released the Annual Report on the Status of Clinical Trials for New Drug Registration in China (2020). The number of clinical trials for new drugs increased significantly in 2020, with a total of 2,602 trials registered, representing an overall increase of 9.1% compared to 2019. Domestic sponsors accounted for more than 70%.

Amid a significant surge in the number of clinical trials, pharmaceutical companies are facing year-on-year increases in both financial and time costs for clinical research. This trend is driven by factors such as increasingly stringent regulatory reviews for clinical trial and drug applications, rising patient recruitment costs, reliance on purely manual subject management models, and the implementation of the new 2020 Good Clinical Practice (GCP) guidelines. Consequently, there is an urgent need to leverage digital technologies to reduce costs and enhance efficiency.

Furthermore, from the institutional perspective, hospitals serving as clinical trial resources face dual pressures of disciplinary development and declining revenue amid the pandemic. They are therefore eager to leverage digital technologies to build research-oriented hospitals, undertake more clinical trial projects, and enhance both clinical research capabilities and disciplinary standards while increasing hospital revenue.

Currently, digitalization is permeating the entire process of clinical research, including initiation, execution, and follow-up, and is gradually extending into areas such as clinical trial management, remote monitoring, pharmacovigilance, and real-world studies.The application of systems such as EDC and CTMS has improved the quality and efficiency of clinical trial data collection, enhanced the standardization of clinical data, enabled unified management of clinical trial projects, and standardized project workflows.

1. How Can Digitalization Solve the Persistent Challenges of High Efficiency and Low Cost in Clinical Trials?

2. How to Compliantly Unlock the Value of Clinical Research Data Assets?

3. How to Effectively Implement Digital Clinical Trial Protocols?

4. At this critical juncture of digital transformation, how can sponsors, CROs, and research institutions keep pace?

In the Era of the Digital Economy, How Can Digital Technologies Further Reshape Clinical Trials in an Efficient and Orderly Manner?

On July 22, 2022, VCBeat will"Digital Clinical Trials"as the theme, inviting renowned enterprises in the life sciences sectorTaimei Medical Technology, Yaosheng Health Technology, Yansu MedicalThree Executives: An Innovative CRO Technology Platform in Pharmaceutical R&DYao Yan SheCo-founders and others shared their perspectives, aiming to clarify the strategic direction for the digital transformation of clinical trials.

Ma Dong | General Manager, Clinical Research Platform Business Group, TaiMei Medical Technology

Mr. Ma Dong holds a Bachelor’s degree in Medicine from Fudan University, a Master’s degree in Pharmacology from the Shanghai Institute of Pharmaceutical Industry, and an International MBA (IMBA) from the University of Hong Kong. He has also earned certificates in Clinical Research Design and Management from the University of California, San Diego, and as an ISO 9001 Internal Auditor. With over 10 years of experience in clinical research protocol design and operations, Mr. Ma has previously worked in clinical research and medical affairs at leading CROs such as PPD (formerly known as Jingding) and PRA Health Sciences.

Currently, Mr. Ma Dong serves as the Head of the Clinical Research Business Group at Taimei Medical Technology, overseeing the Clinical Research Division, the Platform Division, and the Clinical Research Business Development Department.

Peng Yitian | Co-founder of PharmCube, Head of the Digital Innovation Center

Mr. Peng Yitian, Co-Founder and Vice President of Drug Research Society, Head of the Digital Innovation Center, oversees the innovative integration of the company’s business operations, data, and IT functions.

Yitian Peng has nearly 20 years of experience in the pharmaceutical R&D industry. He previously served as Head of Clinical Operations at Covance/Chiltern, where he gained extensive management experience in the digital innovation of clinical research operations. He possesses comprehensive, end-to-end management expertise across the entire drug development lifecycle, spanning drug discovery, manufacturing, clinical trials, and IT applications.

Zhang Zhi | Co-founder and Chief Business Officer, Yaosheng Health Technology

Mr. Gavin Zhang, as a co-founder, currently serves as the Chief Business Officer of Shanghai Yaosheng Health Technology, fully responsible for the company's business and marketing operations, including sales, marketing, and commercial strategy development.

Prior to joining Yaocheng Health Technology, Mr. Zhang Zhi served as the Head of Channel Sales for the Asia-Pacific region at Medidata. Before joining Medidata, Mr. Zhang held sales, channel, and R&D management positions at companies including Microsoft, Oracle, EMC, and NetApp.

Mr. Zhang Zhi graduated from Tianjin University of Finance and Economics with a Bachelor’s degree in Economics, and earned his Master of Business Administration (MBA) from Peking University and Ghent University.

Wang Taifeng | CEO of Yansu Medical

Co-founder of Hangzhou Cognitive, formerly served at IBM for 12 years as Senior Manager in the financial sector and Senior Debt Investment Manager. With over 20 years of experience in marketing and operations management, along with exceptional fundraising capabilities, he spearheaded the introduction of IBM Watson Health to China in early 2016. He led the startup team through early-stage financing, product implementation, and expansion into oncology, establishing marketing partnerships with dozens of hospitals, key opinion leaders (KOLs), and major pharmaceutical companies.

Taimei Medical Technology adheres to the mission of “making quality medicines accessible,” and is building the infrastructure for the future operation of the pharmaceutical industry, with its business covering pharmaceutical R&D, pharmacovigilance, and pharmaceutical marketing.

The company has independently developed a comprehensive suite of professional software products and innovatively created TrialOS, a platform centered on collaboration that connects pharmaceutical companies, hospitals, service providers, regulatory agencies, patients, and other stakeholders. This initiative significantly enhances the overall quality and efficiency of pharmaceutical R&D, driving value upgrades and win-win outcomes for all parties. To date, the company has engaged in business with over 1,100 pharmaceutical enterprises and CROs, provided digital solutions to more than 660 hospitals, and taken the lead in integrating with the direct reporting system of the National Center for ADR Monitoring as well as relevant databases of regulatory authorities in 34 countries and regions.

Yao Yan She (with Miaoyi Biotech as its parent company) is an innovative CRO technology platform in the field of pharmaceutical R&D, and a high-growth, youth-oriented company with significant market influence in China.

The company is positioned to address common, critical pain points across the industry. Centered on the goal of enhancing the efficiency of pharmaceutical R&D, it implements a “One Body, Two Wings” core strategy: with an innovative model for industry talent supply as the “body,” and data empowerment and technology-driven approaches as the “wings.” The company has independently developed a full-link clinical research SaaS solution, accumulated comprehensive clinical research data capabilities, and established a distinctive “T4S Service System.” Through innovative approaches to industrial digitalization, it effectively reduces pharmaceutical R&D costs, accelerates clinical research cycles, and ensures consistent delivery quality.

Our business scope covers CRO services such as clinical monitoring, project management, regulatory affairs, biostatistics, pharmacovigilance, and medical affairs; SMO services including central site management and patient recruitment and management; FSP services for clinical research talent staffing; as well as intelligent data products and SaaS solutions.

The company’s flagship products include the Trial.Link platform, the Yaoyanshe APP, the Health Secretary APP, MY-TDC, and the Jianyan APP.

Aurora HealthTech specializes in clinical research and development within the life sciences sector and is committed to pioneering a globally leading next-generation SaaS platform for clinical trials. By leveraging cloud computing, big data, and AI technologies, Aurora empowers efficiency improvements across the entire lifecycle of life sciences R&D, ensures clinical data consistency, enhances protocol design and trial execution efficiency, manages cost investments, and accelerates the commercialization of innovative drugs and novel medical devices, ultimately advancing human health.

The founding team of Yaocheng Health Technology boasts extensive product and industry experience, with members hailing from global leaders in relevant fields such as Google, SAP, Verily, Splunk, Medidata, and Veeva.

Yansu Medical Technology (Shanghai) Co., Ltd. (hereinafter referred to as “Yansu Medical” or “CTE”), leveraging its core strengths, directly addresses the persistent challenges in clinical trials. As the first data service provider to achieve seamless integration of multi-center clinical data through a direct data acquisition model, CTE is reshaping the landscape of clinical trial data management!

CTE adopts a subject-centric perspective and pioneers the construction of a holistic subject view, management model, and clinical research thematic database based on Direct Data Capture (DDC). It digitally integrates the entire workflow, including site feasibility studies, clinical trial management, early subject identification, informed consent and enrollment, multiple visits, (remote) monitoring and queries, adverse event management, and central imaging. With compliance as a prerequisite, CTE unlocks hospital-wide and inter-hospital (multi-center) clinical data assets anchored in tertiary hospitals, facilitating the translation of scientific achievements and the development of research-oriented hospitals. It comprehensively enhances the efficiency of clinical trials and the level of data security for research institutions, helps sponsors expand the radius for subject screening and enrollment, achieves the overall trial objectives of “greater volume, faster speed, higher quality, and lower cost,” and reshapes the landscape of clinical trials!

“VB Think Tank” is one of VCBeat’s flagship events, serving as a face-to-face platform centered on exploring solutions in the healthcare sector, with the aim of “focusing on practical challenges and discussing industry trends.” The event conducts in-depth discussions, analyses, and exchanges on the current state of development around core themes, addressing encountered difficulties, pain points, and obstacles. Meanwhile, it gains a thorough understanding of the resource endowments of participating enterprises, fostering practical collaborations through intellectual exchange.