Trial Data Partners with Clario to Advance DCT Solutions in China's Pharmaceutical R&D Market
To further advance the “patient-centric” clinical research model in China, Trial Data Chuangda Pharma, a leading domestic DCT service provider, and Clario, a U.S.-based pioneer in innovative clinical research technology services, have announced a strategic partnership. Together, they will deliver newer and more comprehensive DCT solutions to China’s pharmaceutical R&D market.
Patient-Centric Decentralized Clinical Trials (DCTs) are garnering increasing global attention and significance. This strategic partnership aims to combine Clario’s advanced global DCT solutions with Chuangda Medical’s extensive DCT portfolio and service strengths in China, thereby providing sponsors with rich and innovative DCT services for their clinical research projects in China.
Xia Suqin, General Manager of Chuangda Medicalstated, “We are delighted to partner with Clario. The Chinese market holds immense potential in the field of clinical research. Our collaboration with Clario demonstrates our shared vision for the future, driving innovation in clinical research and setting new standards for patient-centric clinical trial models.”
Terry Burke, Executive Vice President of Clario Electronic Clinical Outcome Assessment (eCOA)stated: “Our partnership with Trial Data marks a new milestone in Clario’s business expansion in China. By joining forces, we aim to combine our unique strengths and resources to help life sciences companies leverage innovative technologies to improve patients’ lives.”
Chuangda Medical is a leading DCT service provider, offering digital innovative solutions for clinical trials. Chuangda Medical conducts clinical research using the DCT model, providing clients with one-stop services that include the establishment of an integrated remote intelligent DCT platform, remote recruitment, electronic informed consent, remote visits, remote data collection, direct-to-patient (DTP) drug delivery, and decentralized specimen collection and management (DFP) services.
Clario is a leading medical research and technology company that provides the industry’s most comprehensive clinical evidence to pharmaceutical, biotechnology, and medical device partners. Leveraging its deep scientific expertise, global scale, and the industry’s broadest clinical endpoint technology platform across decentralized (DCT), hybrid, and site-based trials, Clario helps partners improve patients’ quality of life. It possesses the world’s only technology platform that integrates eCOA, cardiac safety, medical imaging, precision motion, and pulmonary function assessments. Clario’s global team of scientific, technological, and operational experts operates 30 offices in 9 countries, supporting more than 19,000 clinical trials involving over 5 million patients in 120 countries and contributing to 870 regulatory approvals. For 50 years, Clario’s innovations have been dedicated to advancing clinical trials.
Clinical trials are an indispensable stage in drug development, representing the most costly, time-consuming, and critical phase before a new drug can be marketed. According to data from EvaluatePharma, recent R&D expenditures for individual drugs have ranged from $2.4 billion to $5.1 billion. Of this amount, 60%–70% is allocated to clinical studies, which take an average of approximately 12 years to complete, with 86% of studies experiencing delays.
The traditional hospital-centric model of clinical research is now highly mature, yet it still fails to address three major pain points: high costs of clinical trials, prolonged trial durations, and low patient compliance. There is an urgent need for innovation in clinical research models.
The application of Decentralized Clinical Trials (DCTs) offers numerous advantages over traditional clinical trials. For patients, participating in clinical trials remotely significantly reduces their burden and enhances their experience and engagement. For sponsors, adopting the DCT model can lower research costs and improve regulatory efficiency. For clinical research personnel, the DCT model enables integrated data collection and management, facilitating convenient and efficient management of trial participants. It also improves the accessibility and efficiency of research, mitigates geographical limitations, and truly achieves multi-party benefits.
However, due to uncertain factors such as the complexity of processes and technical operations under the new model, the practice of Decentralized Clinical Trials (DCT) also poses challenges to the uniformity of clinical trial evaluation criteria, data integrity, result comparability, and operational standardization.
Recently, the successive release of relevant policies both domestically and internationally has propelled the development of DCT to new heights.
On May 2, 2023, the U.S. FDA released the Draft Guidance on Decentralized Clinical Trials (DCTs), aiming to provide guidance and recommendations to sponsors of clinical trials for drugs/biologics and medical devices. The guidance states that DCT activities are not necessarily limited to investigative sites; they may also be conducted at local healthcare facilities or through telemedicine visits with trial participants.
On July 27, 2023, the Centre for Drug Evaluation (CDE) of the National Medical Products Administration officially issued and implemented the “Technical Guidelines for Patient-Centric Design of Drug Clinical Trials (Trial),” the “Technical Guidelines for Patient-Centric Conduct of Drug Clinical Trials (Trial),” and the “Technical Guidelines for Patient-Centric Benefit-Risk Assessment of Drugs (Trial).” These guidelines cover the entire lifecycle of drug development, addressing various stages of clinical trials such as design, conduct, and benefit-risk assessment. They set forth principled requirements for decentralized clinical trial (DCT) components, including remote recruitment, electronic/remote informed consent, remote visits, direct-to-patient drug delivery, collection of patient experience data, and remote monitoring, thereby providing orderly guidance for the practice of DCTs in China.
The core philosophy of DCT is “patient-centric.” Centered on this concept, Chuangda Medical has independently developed the Trial Data DCT Intelligent Integrated Clinical Research Platform. This suite of clinical research products includes the Trial Data OS Remote Intelligent Clinical Research Operations Platform, the Trial Data DP Integrated Clinical Research Data Platform, and the Trial Data OA GCP Institution Integrated Management Platform, providing more efficient one-stop solutions for clinical research projects.
Ms. Xia Suqin, founder of Chuangda Medical Technology (Shanghai) Co., Ltd., stated that many people’s understanding of Decentralized Clinical Trials (DCTs) remains confined to the level of system tools. In reality, DCT represents a distinct operational model for clinical research, fundamentally entailing a transformation in the patient’s clinical trial journey. To truly realize the value of DCTs, it is essential to organically integrate the patient journey with clinical research operational processes. System tool platforms serve merely as the foundation; the key lies in the networked integration of resources across clinical operational pathways.
Based on this approach, Chuangda Medical has integrated multi-channel resources to connect and streamline the numerous third-party services required in the clinical research process, thereby establishing a comprehensive ecosystem for end-to-end Decentralized Clinical Trial (DCT) services. This ecosystem encompasses the development of an integrated remote intelligent DCT platform, remote recruitment of clinical trial participants, participant screening and electronic informed consent, remote visits and data capture, patient management and centralized monitoring, Direct-to-Patient (DTP) remote drug delivery and Direct-from-Patient (DFP) remote sample management, as well as project management and risk-based remote monitoring.
The company’s core strength lies in its integrated “four-in-one” capability—comprising an integrated platform, localized capabilities, multi-channel resources, and end-to-end services—to provide clients with flexible and effective clinical solutions.
Chuangda Medical boasts a team with extensive experience and diverse backgrounds. The company’s founder, Ms. Xia Suqin, graduated from Nanjing University of Chinese Medicine with a major in Clinical Pharmacology. She has previously held positions at internationally renowned CROs and multinational pharmaceutical companies, such as IQVIA and Roche, accumulating substantial resources and expertise in the design and execution of clinical studies.
To date, Chuangda Medical has collaborated with over 50 large pharmaceutical companies to conduct more than 280 clinical research projects. Among these, projects utilizing the Decentralized Clinical Trials (DCT) model span multiple therapeutic areas, including central nervous system disorders, oncology, immunology, rare diseases, pediatrics, dermatology, neurointervention, nutrition, and ophthalmology. Moving forward, Chuangda Medical will remain committed to advancing the field of clinical research. By leveraging digital solutions within the DCT framework, the company aims to enhance participant accessibility and convenience, improve the quality and efficiency of clinical studies, optimize resource allocation, and reduce research costs, ultimately making clinical research easier to conduct worldwide.
Reference: “Pioneers in Decentralized Clinical Trial Practices: Xia Suqin’s Journey in Clinical Research”