Congratulations! The first phase of the Hainan Province Clinical Real World Data Research Platform project undertaken by Medi-Unity's Medi-Unity Cloud has successfully passed the initial acceptance.

Recently, the preliminary acceptance evaluation meeting of the Phase I project of Hainan Province's Clinical Real World Data Research Platform was held at Lecheng Administration. After the expert group's evaluation, it was agreed that the project passed the preliminary acceptance. The smooth passing of this preliminary acceptance means that the platform will enter the trial operation phase, also a high recognition and affirmation of the work done by MediCloud in the project.$YIDU TECH (02158.HK)$This successful preliminary acceptance implies that the platform will enter the trial operation phase, signifying a high recognition and affirmation of the work done by MediCloud in the project.

The preliminary acceptance evaluation meeting of Phase I of Hainan Province's Clinical Real World Data Research Platform was chaired by Fu Zhu, a member of the Party Committee and Deputy Director of Lecheng Administration. The acceptance experts are composed of experts in pharmaceutical supervision, big data management, medical information, methodology, and other related fields, including leaders from Hainan Province's Drug Administration, Hainan Province's Big Data Management Bureau, Hainan Province's Real World Data Research Institute, Hainan Province's Medical Information Research Institute, and Hainan University's School of Information and Communication.

A representative of the project team of the construction unit Yiduyun attended the meeting and reported on the project construction.

The expert group separately listened to the project background, construction, and supervision reports from the Lecheng Management Bureau of the construction unit Yiduyun and the supervisory unit. Subsequently, on-site inspections were carried out on project equipment, platform system function construction, completion documents of the construction unit, and completion documents of the supervisory unit, followed by questioning and discussion.

The expert group unanimously agreed that the Hainan Real World Clinical Data Research Platform has mechanism innovation, technology innovation, regulatory innovation, and service innovation. The construction unit Yiduyun completed the construction contents specified in the project approval documents, bidding documents, and project contracts. They agreed that the project passed the preliminary acceptance, while also providing suggestions for improvements for the next steps.

Building an innovative drug development and registration center connecting China and the world.

Hainan Boao Lecheng International Medical Tourism Pioneer Zone (referred to as Lecheng Pioneer Zone) is China's first 'medical special zone', enjoying the national 'unique' policy for imported medical devices.

Hainan Real World Clinical Data Research Platform is China's first regional real world data platform created in accordance with national guidelines on real world research, supporting Lecheng in building an internationally leading real-world research base.

In June 2021, Yiduyun stood out in the bidding procurement for the 'Hainan Real World Clinical Data Research Platform (Phase I)' project with outstanding medical expertise, clinical data processing technology, algorithm advantages, and stringent pursuit of system architecture security, becoming the construction unit for the project.

The smooth passing of this initial acceptance signifies the platform entering the trial operation phase, which will accelerate the progress of real-world research pilot work and expand the influence of real-world research and applications in the registration and listing of imported pharmaceuticals.

One platform, six systems, five users, four innovations.

Hainan Province Clinical Real-World Data Research Platform.Construction includes data collection governance platform, real-world research service applications, specialized disease data management system, business supervision system, data security and privacy protection, basic support platform.Six major systems.Mainly serving applicants, Lecheng Administration, regulatory authorities, researchers, and patients.Five user categories.。

As the review experts said, the platform is innovative in mechanisms, technology, regulation, and services.In four aspects.Providing data support for conducting real-world research on pharmaceutical registration in the Lecheng Pioneer Area, meeting the needs of regulatory authorities for in-process and post-process supervision, and remote verification.

In addition, the platform has good scalability and will support the integration with Hainan Province and even key national regions' real-world data platforms in the future, helping to achieve data interoperability. It can lead to a new situation of collaborative development in clinical research innovation, medical tourism services, and digital health industry.

The construction of the Hainan Province Clinical Real-World Data Research Platform is expected to officially launch in April 2022.

The establishment of the Hainan Province Clinical Real-World Data Research Platform is an important practice and exploration for China to establish new standards, methods, and tools for real-world research, providing a reference example for the collection, governance, and application of real-world data in China.

As an explorer in the field of AI in the Chinese medical sector, iFlytek will shoulder the responsibility, ensuring the smooth landing and application of the project with a positive attitude, solid technical capabilities, and excellent business qualities.

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