Clinical Service Center 2023 DIA conclusion
From June 16th to June 19th, 2023, the China International Drug Information Conference (DIA) Annual Meeting and Exhibition, themed 'Promoting the Accelerated Implementation of ICH Guidelines in China,' was grandly held at the Suzhou International Expo Center.
On June 17th, Deputy Director General Zhao Junning and his delegation from the National Medical Products Administration (NMPA) visited the Clinical Service Center booth, engaging in discussions. Director General Zhao showed keen interest and inquired about the company's innovative achievements in the integrated and internationalized fields of clinical research services. He attentively listened to the introduction provided by Mr. Daniel Liu, Chairman of Clinical Service Center.
Clinical Service Center had distinguished speakers at this conference, including Dr. Daniel Liu, Chief Scientific Officer; Dr. Hualong Sun, Chief Operating Officer; Mr. Yongliang Liu, Project Management Director; Ms. Xiaoli Xi, Director of Human Resources and Administration; and Mr. Xiao Wang, Deputy General Manager of Meta Data. Under the themes of "Embarking on a New Chapter in E6 GCP Transformation," "Data Science," "Development Trends of Clinical Trial Digital Platforms," "Future Talent Development in Clinical Data," "Collaborative Win-Win in Clinical Trial Operations," and "Blinding Management and Blind Data Processing in Clinical Trials," the presentations proceeded smoothly. Our experts and scholars shared their insights, making the event a great success.
At the workshop session themed 'Data Science,' led by Dr. Daniel Liu, Chief Scientific Officer, and Dr. Hualong Sun, Chief Operating Officer, both from the Clinical Service Center, discussions revolved around the continuous emergence of new technologies in the digital era, fostering the evolution of clinical research towards informatization, automation, digitization, and intelligence. Throughout this transformative process, personnel involved in clinical research are required to leverage their expertise actively, integrating new technologies to enhance various aspects of their work. This includes activities in clinical data management, such as intelligent data collection, automated database construction, real-time data cleaning, dynamic workflow management, and efficiency control, among other stages.
The workshop program invited both international and domestic industry experts, including clinical institution management personnel, IT professionals, data managers, biostatisticians, and programming specialists. The discussions focused on the application, practice, and exploration of intelligent digital technologies in data management. Simultaneously, the participants explored ways to enhance their skills and capabilities amidst the wave of technological change."
Dr. Hualong Sun, Chief Operating Officer of Clinical Service Center Medical Research Co., Ltd., discussed the topic of "Blinding Method Management and Blind Data Processing in Clinical Trials" at the 2023 DIA. He emphasized that randomized controlled clinical trials are considered the gold standard in clinical research and represent the highest level of evidence in evidence-based medicine. In addition, he highlighted the crucial role of blinding in the design of randomized controlled trials.
Ms. Xiao Wang, Deputy General Manager of Meda Clinical Data Technology Co., Ltd., shared her perspectives on "Considerations in Blinding and Blind Data Management" and engaged in discussions with other experts. Dr. Sun emphasized that blinding is an indispensable factor in randomized controlled trials. The process of blind data processing is integral throughout the entire course of a clinical trial. Managing blind data often involves specifying the limitations of blind data, maintaining blinding, and coordinating a series of interdepartmental tasks. The importance and complexity of blind data management are self-evident, and standardization of related processes is a regulatory concern.
Dr. Sun noted that the setting and maintenance of blinding are critical elements in the clinical trial process. The management of blind data is often associated with defining blind data, maintaining blinding, and coordinating various cross-departmental tasks. The importance and difficulty of blind data management are self-evident, and the standardization of related processes is also a regulatory concern.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines point out that blinding and randomization are the most important methods to avoid bias in clinical trials. Domestic regulatory authorities have also issued several guidance principles regarding the setting of randomization and blinding, repeatedly emphasizing that randomization, when combined with blinding, effectively avoids predictability in group allocation and better prevents biases in trial operations and judgments. Therefore, it can be said that the setting and maintenance of blinding are among the key factors in the clinical trial process.
Dr. Hualong Sun, Chief Operating Officer of Clinical Service Center Medical Research Co., Ltd., and Mr. Liu Yongliang, Project Director of the Clinical Operations Center, delivered speeches on the theme of "Collaboration for Success in Clinical Trial Operations." Dr. Sun emphasized the importance of multi-party cooperation in the execution of clinical trials, involving sponsors, CROs, research institutions, and SMOs. He highlighted that the smooth progress and high-quality delivery of a clinical trial require close collaboration among all stakeholders. Dr. Sun discussed optimization of processes, risk management, and effective communication and collaboration from the perspectives of research institutions, sponsors/CROs, and SMOs. The goal was to promote the rapid advancement of clinical trials and ensure the high-quality delivery of clinical data.
Ms. Xi Xiaoli, representing Clinical Service Center Medical Research Co., Ltd., shared her unique insights on the "Development of Clinical Data Management Talent." She pointed out that in the current industry talent market, companies frequently undergo organizational restructuring and optimization, leading to a reduction in the number of recruitment positions and a slowing down of the hiring process. In this challenging environment, the demand for the stability of talent has increased, with preference given to individuals possessing a combination of skills and high overall quality. Ms. Xi Xiaoli also highlighted economic pressures and multiple challenges in the market competition, presenting an unprecedented crisis for talent in clinical data management. Addressing how to turn these challenges into opportunities at the industry, company, and individual levels, transforming them into driving forces for innovation and progress, has become an urgent issue that needs resolution.
The booth attracted a continuous stream of visitors seeking information and collaboration. Attendees expressed great interest in Clinical Service Center's clinical monitoring, data management, biostatistics, registration, and pharmacovigilance services in the fields of oncology, rheumatology, immunology, endocrinology, ophthalmology, and cardiovascular diseases. The Clinical Service Center team warmly welcomed exhibitors, actively addressing inquiries from a professional perspective, and providing comprehensive overviews of the company's business and successful project experiences since its establishment. Through these interactions, representatives from various companies and industry experts gained a deeper understanding of Clinical Service Center.