On January 26, hosted by Boao Lecheng Clinical Research Center and Hainan Institute of Real World Data, organized by Hainan Yiling Medical Industry Development Co., Ltd., and Hainan Boao Lecheng Tiger Medical Technology Co., Ltd., the launch event of the ESR Project of Boao Lecheng Clinical Research Center and the strategic cooperation signing ceremony between Hainan Boao Lecheng Tiger Medical Technology Co., Ltd. and Hainan Yiling Medical Industry Development Co., Ltd. were held grandly at Boao Yiling.

eSource Record tool creates an innovative model for the high-quality development of medical industryAt present, limited by the lack of data interoperability among the information systems of hospitals in China, there are many difficulties and challenges for using medical data in real-world studies. To solve these problems, Yao Chen, the vice president of Hainan Institute of Real World Data, based on his many years of clinical research and practice, keeps exploring the collection and governance modes of real-world data and has developed integrated solutions for real-world data collection, governance and management of hospitals. He has also cooperated with Boao Lecheng Clinical Research Center and Hangzhou Laimai Medical Information Technology Co., Ltd. to develop the innovative eSource Record (ESR) tool. At the site of the event, the ESR program of Boao Lecheng Clinical Research Center was formally launched.

Liu Zhefeng, Party committee member and deputy director of Boao Lecheng Administration, offered his warm congratulation to the successful launch of the ESR project. He said, the successful R&D and trial application of the ESR project cannot do without the support of various parties and hoped that Lecheng Clinical Research Center can take it as a new start and work with more brother organizations, medical institutions, experts and scholars to build Lecheng Pilot Zone into an internationally leading clinical research base and consortium, actively promote the application of more forward-looking achievements, and set up an example for the development of real-world studies.

Qu Jia, the executive president of Hainan Institute of Real World Data, said, in the future, each medical institution in the park will rely on the various preferential policies of Lecheng Pilot Zone and the big database of ESR to effectively improve the medical service quality and make “Hope City” benefit more patients.

Yao Chen, the vice president of Hainan Institute of Real World Data, shared the research and development background and process of ESR. He said, the ESR project can provide high-quality source data for the construction of Hainan Real-world Study Platform and the various real-world study programs under way, which is expected to address and solve the bottleneck faced by the real-world studies of imported special drugs and medical devices in the Lecheng Pilot Zone.

Hao Xinbao, a doctor with Boao Clinical Research Center, introduced, the ESR project boasts various advantages such as real-time collection of source data, efficient medical history record, in-built logic check, NLP automatic-filled eCRF, audit trail, improving the examination efficiency, satisfying data quality standard, compatibility, extensibility and compliance and in-house localized deployment.

It’s reported that the ESR system was put into trial operation at the Life Care Center of Boao Yiling this June, which had proven its feasibility and application value. In the future, it will continue to be applied in other medical institutions at Lecheng Pilot Zone and further promote the pilot programs of real-world data application and build Lecheng into an international highland of real-world studies.

Yiling and Tiger co-build Quality Management Standard Center of Drug Clinical Trials

On the conference, Tiger Medical and Hainan Yiling Medical Industry Development Co., Ltd. signed a strategic cooperation agreement. Both parties will have in-depth cooperation in various business related with clinical trials such as the building of a clinical trial and research system, the operation of clinical research programs, talent training, project practice training, clinical trials of drugs, medical devices, diagnostic reagents, real-world studies, and the building of related systems. Tiger Medical will be entrusted with the full authority to build, run and manage the Clinical Trial Institution of Boao Yiling and help Yiling introduce high-quality clinical trial programs.

Wei Maiguo, the director of Lecheng Medical Products Administration, said, “We hope that Yiling and Tiger can give full play to the policy advantages of Hainan Free Trade Port and Lecheng Pilot Zone. With the aid of the development of CRO in the Pilot Zone, they can further improve the clinical research capacity of medical institutions in Lecheng Pilot Zone, strengthen resource integration and scientific research cooperation among medical institutions inside and outside the province, attract more internationally advanced innovative drugs and medical devices to promote the constant upgrade and optimization of the industrial structure in the Pilot Zone.”

Cao Xiaochun, president of Tiger Medical, introduced the development plan of clinical research and the prospect of the GCP co-built with Hainan Yiling for the guests. She said, hopefully through co-building a high-level and high-standard GCP center with Hainan Yiling, they could speed up the marketing of quality drugs and medical devices with clinical values that can satisfy clinical needs to meet the expectations of more patients for new drugs and therapies and build Lecheng into a highland of clinical innovation.

Li Wei, chairman of the board of Hainan Yiling, said, the cooperation between both parties will set up an example for the clinical trials and real-world studies in the pilot zone, and hoped that both parties could strengthen communication and cooperation, share resources and supplement the advantages of each other, make in-depth discussions on issues such as clinical research theory, model and system and promote the improvement and development of clinical trials in Lecheng.