The first meeting of the Expert Committee of the CMAC DCT Alliance and the DCT Research Seminar.
On January 12, 2024, the "First Meeting of the Expert Committee of the CMAC DCT Alliance and the DCT Research Seminar" was successfully held at the Shanghai IFC.
Guidance experts from Peking University Cancer Hospital, Beijing Chest Hospital, Beijing Tsinghua Changgung Hospital, Beijing You'an Hospital, Huashan Hospital Affiliated to Fudan University, Shanghai Mental Health Center, Shanghai First People's Hospital, First Affiliated Hospital of Bengbu Medical University, Gaozhou People's Hospital and other institutions; Expert representatives from the DCT Alliance Committee of Pfizer, Simcere, Eli Lilly, Takeda, Sanofi and Susu Technology; More than 70 guests from BeiGene, Roche, Bayer, Hutchison, AstraZeneca and other sponsors gathered together to discuss the alliance's 2023 work report and 2024 work plan, and are committed to making suggestions for promoting the high-quality development of remote intelligent clinical trials in China.
2023 Annual Work Report of the DCT Alliance
This session was hosted by CMAC Founder & Head of the DCT AllianceLi JingchengPreside; By the CEO of Susu Technology & Head of DCT AllianceLu NingHe made a report on the work of the DCT Alliance in 2023, and he reported from three aspects: DCT practice in China, live broadcast activities and innovation landing.
Li Jingcheng, founder of CMAC & head of DCT Alliance.
Lv Ning, CEO of Susu Technology & Head of DCT Alliance.
In the "CMAC DCT Practice China Tour into Well-known Pharmaceutical Companies Series Activities", CMAC DCT Alliance has successively visited five well-known pharmaceutical companies: Pfizer, Simcere, Eli Lilly, Takeda and Sanofi; The TCT Practice China Tour is scheduled to enter Hutchison in January, Bayer in February, and BeiGene in March 2024. From March to May, he walked into several well-known institutions such as the First Affiliated Hospital of Nanyang Medical College.
In terms of live broadcast activities, a series of 12 live broadcast events and academic conferences were successfully held to share experience on hot topics such as DCT, smart healthcare, and digitalization, and discuss DCT-related topics such as innovative technology, law, regulation, compliance, and ecological construction.
In terms of innovation implementation, we launched the DCT "Top Ten Innovative Practices" case collection, the selection of the top ten pioneers, and the research activities, taking successful cases and commendation of advanced as the starting point to drive industry innovation and promote the sustainable innovation and high-quality development of China's DCT industry.
Finally, Lu Ning described the top ten development directions of China's DCT in 2024.
Presentations by experts
At the meeting, Li Jingcheng invited online experts and on-site experts to discuss and plan the work in 2024, and the important matters discussed included the top ten pioneers of DCT, the selection of the top ten cases of DCT, research directions, and DCT subject research.
According to the order of the speeches of the participating experts
Deng Li, Director of the Institutional Office of Gaozhou People's Hospital.
The payment system needs to be reformed to ensure that risks are manageable.
Regarding the sponsor's plan, large enterprises have the strength to outsource the project to a large CRO company that can issue a more rigorous plan, and after multiple rounds of revision, it is more reliable at the executable level; However, small enterprises are limited by capital settings, and the CRO companies they are looking for are generally relatively young, with uneven ability to work together, and there are many loopholes in the operation process. Shifting the pressure to the clinician is a highly skillful move that requires the clinician to be flexible in the optimal selection of subjects, which is actually irresponsible. In view of the limitations of each expert's cognition, improving the quality of the protocol can help experts to be more grounded and sustainable in clinical practice, and can also help subjects to be successfully enrolled.
on the waterfront
Director of the National Drug Clinical Trial Institution Office of Beijing You'an Hospital.
There are many problems faced by the implementation of DCT on the institutional side, which will be limited by the current network construction, multi-platform information sharing, and barriers at the level of DCT regulations. To implement DCT at the institutional level, it is necessary to write a corresponding SOP system to ensure that the plan is carried out truthfully and compliantly. Although there are certain barriers to remote door-to-door follow-up and clinical diagnosis and treatment and the current DCT, we can try it first, and carry out corresponding exploration and academic co-construction.
Shen Yifeng, Director of the Institutional Office of the Shanghai Mental Health Center.
First, the promotion of DCT can be summarized by a few key words. For the best business, it is necessary to "save money", "save people" and "save time"; In addition, attention should be paid to "improving efficiency" and "improving quality", and there has been clear progress in these two aspects.
Second, understand the source of DCT. The DCT itself is not actually the source, but should be guided by the needs or preferences of the patient. This is not only the general trend, but also makes the project easy to carry out.
The implementation of DCT should consider the optional scenarios, which is different from the traditional mode. First, let patients have the path of whether to enter the hospital for medical treatment, reflect the value and advantages of the project to choose the DCT model, and take a long-term view of the development trend of the industry; Second, pay attention to external drivers, such as the promotion of DCT by the epidemic, but also carefully explore the problem of the immaturity of DCT itself.
Gao Jingtao, deputy director of the hospital office of Beijing Chest Hospital.
In terms of the implementation of DCT, there are still several problems in e-payment and e-consent.
First of all, funding. Given the stringent nature of the regulatory approach to the entire financial process and certain chains, the implementation of e-payment in hospitals is sensitive to compliance. Even if a company conducts a purely scientific research clinical trial with a hospital, it will inevitably be questioned, not to mention the doping of digital technology, and it will become a real problem to be mistaken for compliance and financial risks.
Secondly, time. The time here refers to the time when the patient is paid in time. Based on the needs of patients, e-payment can efficiently solve the problem of difficult cash for patients caused by manual operation errors caused by complex matters.
Finally, innovation. Due to the long length of e-consent, there will be problems that patients do not understand, and then there will be problems such as doctors not wanting to see and compensation problems caused by adverse events during the period. Therefore, the promotion of e-consent is imperative, but there is still the problem of low smartphone version for patients, so innovation is the next step for us to move forward and work hard.
Jiang Min, Director of the Office of the National Drug Clinical Trial Institute of Peking University Cancer Hospital.
The original intention of the implementation of DCT should be to solve the specific problems of work, such as payment, optimization and efficiency of the entire clinical trial process for patients.
In cancer clinical trials, due to the characteristics of complex scenarios, long trial cycles and wide distribution of patients, it is easier to solve part of the work with remote monitoring and communicate with the sponsor about the corresponding demands, and it is easier to make the project land.
Implementing DCT on the patient side is more complex than remote monitoring. For example, the implementation of remote e-consent will have compliance issues, and hospitals should ensure data traceability requirements on the basis of not adding additional burden to patients when linking patients; Whether the electronic method is easier for patients to understand, so as to better improve patient compliance.
In addition, in the DCT scenario, pay attention to whether the patient's data privacy, data traceability, so-called signature, and compliance at the medical document level are aligned at the legal level. In this process, the institution should communicate with the patient, the investigator and the sponsor. For patients, we need to understand their needs and provide help; For researchers, we need to consider the executability of the project process; As for the sponsors, we need to be able to listen to their insights and suggestions throughout the design process of the project, and finalize some implementation links together. When the project is implemented, we need to implement the details at the practical level under the regulatory system, and accelerate the project process and improve the quality under the regulatory and recognized DCT framework.
Cao Yuran, deputy director of the Institutional Office of Huashan Hospital affiliated to Fudan University.
At present, the exploration and practice of DCT scenarios in our hospital are mainly reflected in four aspects, which still need to be continuously improved.
First, the data acquisition system is widely used, which is mainly used in the phase clinical trials of the project.
Second, the remote monitoring system has not yet been implemented because it may involve the leakage of patient or hospital data and the control of the authority of the corresponding personnel.
Third, e-payment and e-consent. In the case of e-payment, we tried for the first time a survey that was not for the purpose of registration. In the specific ethics review process, the ethics committee had a heated discussion on the third-party payment method and the protection of subject information. In the subsequent contract signing process, institutions, hospitals, and third-party payment companies also reached a final contract with clear terms after a long period of negotiation and communication. Eventually, the project was launched.
Fourth, the device is worn by the subject, which is used for the first time to collect the corresponding information during the clinical trial of healthy subjects.
Chen Chaohua, General Manager of Pfizer (China) R&D, Head of R&D Center, and Vice Chairman of the DCT Alliance Special Committee.
In 2024, the key work of the CMAC DCT alliance should focus on the practical problems and countermeasures of remote intelligent clinical trials. As the core think tank of the NMPA, our research group will actively promote the process and development of clinical trials in the entire industry and in China.
Under this premise, our industry should use the same language to communicate and track the progress of DCT, and tell the corresponding story, know the outline of the present and the future, and know the most effective path to growth, so as to form a synergy in the industry. In order to promote the promotion of DCT in China, we can consider forming a standard analysis report for common reference in the industry, combing the collected information to form an authoritative data benchmark and positioning, and issuing an annual report to track changes. If realized, this will become a powerful tool to improve the development of the industry, and the DCT project data will be visualized and quantifiable, becoming a special tool and unified language for the industry. It is convenient for the entire industry to observe the implementation of DCT in China over the years, so as to position; If it can be extended to the world, it will also be convenient to observe the progress of China's DCT and the global DCT, and find out the development projects with Chinese characteristics.
Vice President of Global R&D, Head of Asia Pacific R&D Center, Vice Chairman of the DCT Alliance Committee, Wang Luan.
The implementation of DCT requires the joint construction of multiple parties and the strong support of enterprises, hospitals and technical partners, and the CMAC DCT Alliance will play a huge role.
First, the implementation of DCT in China should be part of global R&D, rather than being built behind closed doors, and should develop synchronously with the world and be in line with the world. Otherwise, this is not a real DCT practice.
Second, sponsors should pay attention to the accuracy of clinical trial site selection, which is very important to improve the efficiency of the entire drug development. We need to really understand where the corresponding patients are and what the expertise of each site is, and effectively aggregate the information.
Sun Lei, Executive Director of Pfizer (China), Head of Clinical Trial Management Department, and Standing Committee Member of the DCT Alliance.
First, the CMAC DCT Consortium needs to confirm positioning. Our policy is unique to China, whether we are introducing China from the world, or whether China is leading the world.
Second, if we return to the research itself, we need to be clear about whether this approach can really play a role in supporting simultaneous R&D and accelerating the R&D of innovative drugs.
Third, to complete the missing parts of the situation, taking into account the patient's tissue, so as to obtain more useful information.
Sun Binxian, Executive Director of the Clinical Operations Department of Simcere Pharmaceuticals and Standing Committee Member of the DCT Alliance Special Committee.
In the early days of DCT's practice, Simcere encountered the following three problems. First, how to make it more convenient? Second, what is its quality? Third, what about its regulations?
DCT should be an ecological environment that considers both convenience and patient-centricity. On the one hand, the CMAC DCT Alliance can become a trusted organization for sponsors, providing them with a reliable business choice. On the other hand, formulate industry development standards, control the quality of DCT development, discover industry pain points, let the law go first, leverage the resources of industry leaders, reach a consensus with regulators, and promote the normal ecological development of DCT.
Bin Yang, Vice President, Clinical Operations, Chi-Med.
In view of the lack of clarity in national laws and regulations on digital application and the huge investment in clinical trials, there are three difficulties in carrying out DCT.
The first difficulty is that according to the current development process of DCT in China, the precise selection of sites and the tension of hospital resources still need to be solved by us.
The second difficulty is that from the perspective of data security, non-MNC and domestic enterprises supported by the state need to implement the strictest standards, and there are many restrictions on overseas projects.
The third difficulty is matching, even if some special tests may do low-quality investment, if there is no supporting thing, it is still difficult to carry out.
Guo Tong, Vice President of Business Development of IQVIA Greater China and Vice Chairman of the DCT Alliance Committee.
First, we need to actively communicate with regulators and help regulators work together to formulate corresponding rules to truly promote the effective implementation of DCT.
Second, for institutions, we must achieve data visualization, structuring and standardization, and truly implement "saving money", "saving people" and "saving time".
Third, on the sponsor, we should set up a business alliance to form a complete set of business evaluation parties and improve the quality of business partners.
Fourth, for patients, truly implement the "patient-centered" development concept, and truly include patients in the consideration of DCT development.
Ge Yongbin, senior partner of Zhong Lun Law Firm and vice chairman of the DCT Alliance Committee.
First, in terms of quality, the management of the first business will be incorporated into the QMS and preparation management guide system to promote the compliance management of the first business. The establishment of a corresponding white list of first-class businessmen can not only provide high-quality foreign first-class businessmen, but also make truly excellent domestic first-class businessmen stand out.
Second, in terms of project implementation, in view of the fact that DCT involves regulations on drug regulatory regulations, data security, cross-border data, MRCT and ethics, etc., and it is impossible to easily learn from foreign experience, it is imperative to reach an industry consensus with the help of the China Drug Administration Research Association.
Gong Ying, Executive Director of Pfizer (China), Head of China Clinical Development Quality Department, and Standing Committee Member of the DCT Alliance.
See the direction clearly and identify the difficult points. Firstly, through big data, the application scenarios of DCT are learned, the application methods in the corresponding scenarios are clarified, the complex reasons of the project situation are known, and the demand problems in enrollment, data collection, version, and operation are solved. Second, consider regulatory and compliance issues, both of which must be satisfied; Finally, simplify complex problems and use data to speak.
The implementation of DCT needs to be implemented step by step. According to the situation of different companies, clearly illustrate the DCT application scenarios with cases, and then summarize them into corresponding industry reports. It is necessary to pay attention to active communication with regulators, and to conduct self-examination from time to time. Learn to make unclear questions, ask questions, find solutions, and then solve problems.
Bi Lucun, head of Labcorp's bioanalytical laboratory.
After the outbreak of the epidemic, we have used DCT technology to cooperate in the research and development of innovative drugs, and according to the data obtained from a series of operation processes from clinical management to PK sample collection, the effect is better than that of conventional clinical management head-to-head research, and it can cover more patients. At present, Europe and the United States have entered the DCT stage from routine clinical management, and the development of DCT has great potential, and it has great advantages in clinical development and breakthrough in patient ** methods and governance. If DCT is actively developed, managed, and maintained, it will "save money" in terms of clinical development and will have significant benefits in terms of efficiency.
Sun Lei
Executive Director of Pfizer (China), Head of Clinical Trial Management Department, Standing Committee Member of DCT Alliance.
For the issue of diversity, the academic department within the research group will supplement the whole process of the project. Project management, such as project initiation, mid-term completion or extension application; The scope of topic selection can refer to the 17 articles on the Internet, which are standardized and strict.
As a think tank of the Food and Drug Administration, the report of the research society will be distributed to the national leadership bureau and relevant envoys to provide a basis for the relevant regulatory authorities to formulate relevant regulations and guidelines. If our project can be recognized by the relevant direct units, they will participate in the research process of the project throughout the process, participate in each meeting, and revise the research direction and ideas for us, which is the most direct channel to communicate with the CDE.
The implementation of the topic cannot be generalized, and it is necessary to grasp the pain points and difficulties of the industry and supervision, establish priorities, and strive for excellence in order to gain the first opportunity. We need to achieve multi-party cooperation and provide more case sharing to attract the attention of CDE and gain opportunities for communication. In terms of DCT, enterprises are the main body of innovation, and CDE also needs to learn from enterprises, and enterprises can also consult and communicate reasonably with CDE after the establishment of the communication mechanism. Clarify the objectives of the project, produce a report with Chinese characteristics that is in line with China's national conditions and recognized by the industry and regulators in accordance with China's policies and regulations, and then jointly introduce corresponding regulations, systems or principles under the guidance of CDE.
Jin Jiefei, founder & CEO of New Vision.
As far as remote monitoring is concerned, we have made some good progress as a leading business. In fact, there are commonalities in the three lines of supervision, inspection and verification. In terms of remote verification, although we have made a good attempt under the guidance of national inspection experts, we still lack practice. Therefore, to achieve systematic, practical and rigorous topics, promote the participation of drug administration, and obtain sufficient funds should be the problems that our research society should overcome at present.
Su Quanyu, co-founder & chief commercial officer of Linyun.
EPRO and ECOA in DCT are often used in early-stage, post-marketing and registrational clinical trials in China. And abroad, especially MNC, they are very leading in the penetration and application of patient-centered digitalization in EPRO and ECOA. In order to keep pace with the world, China's clinical trials and the development of China's innovative drugs should actively embrace the domestic digital industry and leading companies. Through the NMPA and the CMAC DCT Alliance, we will call for Chinese patients to have a better disease progression and experience through better digital tools under the premise of patient-centeredness.
Zhemin Jiang, associate director of clinical research in BeiGene's region.
First, from the company's perspective, DCT topics can be studied based on unmet clinical needs, such as electronic docking, signing, submission, etc., so as to improve the efficiency of clinical operations. Second, set up a white list of first-class businessmen, conduct reasonable selection by category, ensure quality and set up relevant responsibilities to avoid a vicious circle; Third, with the help of supervision, the epro and e-consent signature standards of domestic and foreign merchants should be leveled.
Yinan Qin, Head of DCT IT Technology at Bayer Pharma.
From a technical point of view, we will actively communicate with institutions in the process of clinical trials, and we have found many patient needs in the process of using DCT elements.
In the case of telemedicine, it is necessary to verify the door-to-door medical care and enter the patient's information; If digital means fail, how can we retain the original patient data during the clinical trial process and record the real information?
In terms of digitalization, the introduction of remote visits by Global is not fully in line with China's reality, and there are many obstacles in terms of software filing, information protection, and cross-border data transmission. There is a strong need for suitable Chinese first-class vendors to support clinical trials to ensure the secure transmission of data from the hospital to the system; It is also necessary for teachers from institutions to exchange and share some desensitized information with us, so that the protection of data security can reach a new height.
It is hoped that with the joint efforts of many parties, the exploration of DCT will have a good result.
Jiang Zijing, senior clinical trial manager of Pfizer (China) and youth member of the DCT Alliance Special Committee.
According to the guiding principles, the recruitment is based on the needs of patients, and the regulations are clear and rigorous.
Regarding the issue of certification of the informed consent form that is easily accepted by patients, the domestic ** chamber of commerce has more advantages, and the selection of foreign ** merchants needs to be more rigorous; At the same time, the implementation of facial recognition technology for patients is based on the minimum principle requirements of the PIPL and the Ministry of Industry and Information Technology, but in view of the different degrees of acceptance of it by different hospitals, the formulation of relevant industry standards is imminent.
Regarding the choice of scenarios, the application of technologies such as remote visits should be completely based on the needs of patients, different from person to person, reduce the burden on patients, and should not be forced.
Regarding the direct delivery of drugs, I hope that everyone will reduce it slightly on the basis of a large amount**.
When it comes to collecting patient data, the reason why we sometimes don't work with local vendors is because we already have vendors at headquarters. In the past six months, the FDA has also begun to focus on the authenticity of patient data and confirm whether it is filled in by the patient himself. Therefore, our local measures such as authentication signature, face recognition, and data structure docking are still very effective.
Regarding remote monitoring, the sponsor is very cautious and attaches great importance to the data. Regulators also have their own concerns and have developed different standards for the latest clinical records of drugs, and institutions are also concerned about the modification of records. However, in the absence of corresponding regulations, the use of remote monitoring still needs to be scanned on paper, which defeats the original purpose of saving workload. Returning to the data issue, if the data structure of the hospital's docking system is relatively simple, and the white list of the hospital is added for the sponsor to choose, the choice of the site will be more straightforward and clear.
Regarding the compensation of subjects, we actively signed a tripartite test with the hospital, and obtained good feedback from patients under the supervision of the hospital.
Xie Fei, Senior Director of Clinical Quality Management Department of Simcere Pharmaceutical and member of the DCT Alliance Special Committee.
First, because different hospitals have their own special requirements, the promotion of DCT application in major hospitals is complicated. From the perspective of development, an alliance is formed at the hospital level to standardize the inpatient system and outpatient system, and achieve consistency in framework, function and data flow. Both at the regional and national levels, it will greatly improve the quality and effectiveness of clinical trials.
Second, in the use of electronic related modules, such as epro, e-payment, e-consent and other systems, establish data standardization that has been recognized by the state or even the world, indicate the framework, function, data flow direction, etc., and use standard data delivery, mutual recognition and exchange to avoid routines and save time.
He Jieru, Deputy Director of R&D Digital Strategy at Takeda Asia Pacific and member of the DCT Alliance Committee.
When it comes to the practice and implementation of DCT, China is stricter than the United States, and if it can establish a bottom-line standard (i.e., the "red line"), it will give the best business business the flexibility to explore and carry out bold practice on this basis.
Huiping Wang, Senior Manager of R&D Clinical Operations at Takeda Asia Pacific and member of the DCT Alliance Committee.
First, when it comes to the "red line" issue, if there are corresponding quality standards and corresponding regulations, it can also meet the exploration needs of DCT technology. Second, the cost problem, if DCT can be widely implemented, the supply exceeds the demand** can naturally be solved. Third, we need to focus on two needs, one is the needs of patients, and the other is to meet certain technical needs based on standards. Fourth, in the process of China's clinical trials, Global DCT is also booming, but in view of the particularity of China, Global DCT cannot operate normally in China. Therefore, if we can establish a set of operating standards that meet the requirements of Chinese laws and regulations, we may be able to better integrate into the development of Global DCT.
Ma Yue, Digital Manager of Clinical Operations at AstraZeneca's Global R&D China Center.
First, it is still in the active development stage in terms of electronic docking with hospitals; Second, in terms of the white list of ** merchants, a reasonable assessment is made according to the expertise of each ** business; Third, it is hoped that the site can accept the compliance and legal assessment of some enterprises and try to start a demonstration cooperation pilot. Fourth, in terms of leveling standards, three directions: compliance, functionality, and user experience can be used as references.
Lu Chen, Director of Clinical Operations of HUTCHMED.
All parties in the entire industry chain have actively expressed some views, but it seems that two parts are missing. First, the patients themselves, we need to listen to the needs of patients, carry out clinical trials with patients as the center, and need the participation of members of patient education organizations; The second is hospital researchers, who promote the development of DCT through their influence, which is also convenient for the advancement of the subject.
In terms of the topic itself, there are many types of clinical studies, and the scenarios of DCT in different studies are not completely consistent. Therefore, different research types should be included in the later stage of the topic analysis or research process, so as to present a more comprehensive report and research results.
Guo Dong, head of statistical programming and deputy director of Eli Lilly China, co-leader of the DCT team, and member of the DCT Alliance Special Committee.
In the research content and method design of the fifth section, four parts have been covered: technical architecture and implementation process analysis, data security and privacy protection, technical standards and norms research, and DCT implementation cases. My advice is threefold:
First, in line with the patient-centered development concept of CDE's "three consecutive developments", we attach importance to patient experience, introduce patients and set up corresponding processes in the research design process, and pay attention to legal and compliant contact. Second, on the leveling of technical standards, on the basis of establishing a general concept, the concept is subdivided according to the field to form a unified standard speech in the industry to avoid ineffective communication; Third, remote visit is the most basic function of allowing patients to participate in clinical trials in the implementation of DCT, but it involves a key technical issue, such as doctor's order records, whether it is a resource, and whether it is recognized by CDE, which will seriously affect the implementation of DCT, and it can be taken out separately for more in-depth research.
Cao Yuran
Deputy Director of the Institutional Office of Huashan Hospital Affiliated to Fudan University.
In order to promote the topic of DCT, it is necessary to grasp the cutting-edge information, grasp the key breakthrough points, and avoid duplication of work.
First, because the main body of innovation is in the enterprise, but the regulatory policy may lag behind, some consensus should be based on active communication with the regulator and on the basis of regulatory recognition, and it also requires the multi-party compliance participation of the National Health Commission, institutions, third parties, subjects and enterprises.
Second, we should make rational use of the resources of all parties and focus on the key points. If you study foreign cases, you should not only do translation work, but also compare Chinese and foreign situations to analyze the risks, worries and doubts that NMPA and CDE are concerned about in the context at that time. If the CDE is willing to work with us to promote the development of the DCT process, we can try to invite the CDE and the relevant departments and verification centers to talk about their doubts and listen to our voices.
Concluding remarks
The meeting came to an end, led by the founder of CMAC and the head of the DCT AllianceLi JingchengMake concluding remarks.
He expressed his gratitude to all the leaders and teams for their support to the event and the valuable experience sharing of the guests. He proposed that the CMAC DCT Alliance will actively adopt the suggestions of the guests to include patient organizations and experts in our "ecosystem" to form a closed loop.
He said that in addition to adhering to the work attitude of "having light in our eyes, material in our stomachs, and mud under our feet", we should also pay attention to "having a heart". First, the original intention, that is, to be patient-centered and truly solve the needs of patients; second, perseverance, do difficult but correct things, with perseverance and lasting perseverance throughout, down-to-earth to do a little thing, small topic or small problem; Third, Hongxin should not only know how to warm drug supervision, warm institutions, and warm PI, but also know how to warm up in a group, and collaborate to build an innovation ecology and a healthy research environment.
While there is still a long way to go, we have taken a solid step together. I hope that we can start from not seeing, and then understand and even go far, and truly promote the implementation of DCT practice in China!
Meeting site. Group photo of guests.
Group photo of guests. In order to improve the standardized, scientific and professional development level of the Alliance, the CMAC DCT Alliance has established an expert committee. The special committee of the alliance is a non-profit organization, which aims to give full play to the professional advantages of experts in various fields, brainstorm ideas, promote the progress of the industry and the development of the DCT technology industry, help the ecological construction of DCT, and provide intellectual support and experience for the reform and development of the industry. The special committee has expanded its membership and invited Guo Tong and Ge Yongbin to be the vice chairmen of the special committee. At the event, Li Jingcheng and Lu Ning presented certificates to the two newly elected deputy directors, Guo Tong and Ge Yongbin.
Letters of appointment are issued. The first meeting of the CMAC DCT Alliance Expert Committee and the DCT Research Symposium was successfully held, with strong support from Yilinyun, Xinshiyan, Susu Technology and Zhong Lun Law Firm.
At the event, everyone listened to the report on the key work of the DCT Alliance in 2023, the key work plan of the Alliance in 2024, and deliberated on the DCT research topics, the important development direction of DCT, the selection of DCT pioneers, the selection of DCT practice cases, and reached a preliminary consensus. The results of the relevant discussions at this meeting will be gradually implemented, let us move forward hand in hand, grow and struggle together in the new year, and contribute to the development of the alliance and even the high-quality development of DCT in China!
Group photo. dct alliance
The DCT Alliance is jointly initiated by CMAC and well-known institutions and experts in the field of clinical trials at home and abroad, aiming to bring together the strength of the whole DCT industry chain such as research institutions, sponsors, and service providers, create a new platform and new pattern for the integration and co-construction of clinical trial innovation subjects such as medicine, enterprises, academia, research, and capital, strengthen international exchanges and cooperation, promote the high-quality development of the industry, promote the implementation of DCT compliance, and contribute to the construction of China's DCT ecosystem.
Reviewer: Wang Zeyan **Li Mengzhu **Easy to accompany.
About Suspeed Technology
Susu Technology is a leading DCT overall solution service provider in China, and is at the forefront of the industry in the fields of intelligent subject compliance management and electronic payment.
Adhering to the persistent pursuit of compliance and efficiency, Susu Technology continues to increase R&D investment and independently develops a complete set of clinical trial SaaS system centered on the "Easy Companion App".
The system is based on the digitalization of clinical trial protocols, and carries functions such as electronic payment, subject compliance management, intelligent hardware, patient education, and remote visit call center. As of February 1, 2024, E-Companion has served nearly 500 projects from 632 clinical trial institutions, more than 170 sponsors, and 43 CROs.