Against the backdrop of accelerated digital transformation in the pharmaceutical industry, Jiangsu Lihua Biotechnology Co., Ltd. ("Lihua Biotechnology"), a leading domestic Contract Research Organization (CRO), has entered into a strategic cooperation with Shanghai Hippocrates Health Technology Co., Ltd. ("Hippocrates") to officially launch the Training Management System (TMS) digital project. The project kick-off meeting was held online, with core teams from both parties and industry experts witnessing this important moment. This marks a crucial step in Lihua Biotechnology's digital upgrade in the field of quality management and sets a new example for the refined management of CRO enterprises in the pharmaceutical industry.

01 Project Background

As a benchmark enterprise dedicated to providing full-chain clinical research services for pharmaceutical companies, Jiangsu Lihua Biotechnology has always taken "professionalism, efficiency, and integrity" as its core values, and particularly upholds strict standards in terms of quality management. In recent years, with the tightening of policy supervision in the pharmaceutical industry and the increasing complexity of clinical research, the limitations of traditional training management models have become increasingly prominent in aspects such as compliance traceability, cross-departmental collaboration efficiency, and data visualization analysis. To support its business strategy of "global R&D, dual filing in China and the US, and international supply," the TMS digital project of Lihua Biotechnology aims to achieve three core goals through digital technology:

• Standardization of training processes: Establish a full-cycle digital management system covering "course development - training implementation - effectiveness evaluation" to ensure that training content is highly aligned with industry standards such as Good Clinical Practice (GCP).
• Efficient resource integration: Build a centralized online training platform to break geographical and time constraints, support multi-terminal access and mobile learning, and improve the efficiency of cross-team collaboration.
• Traceable data management: Realize real-time archiving, dynamic tracking, and compliance auditing of training records through digital ledgers and intelligent analysis tools, providing data support for the continuous optimization of the quality system.

02 Project Kick-off Meeting

To fully advance the implementation of the project, Jiangsu Lihua Biotechnology and Hippocrates jointly held the "Kick-off Ceremony of Jiangsu Lihua Biotechnology TMS Digital Project". The meeting was conducted online, bringing together heads and project team members from relevant departments of Lihua Biotechnology (including Quality Department, Training Department, and Project Management Department) and the project team of Hippocrates in the cloud to jointly discuss the construction path and future value of digital training management.

During the meeting, the two parties conducted in-depth exchanges on topics such as the digital upgrade of training management, compliance assurance, and efficiency improvement, and reached a consensus on the project implementation plan, laying a solid foundation for the smooth progress of the project.

03 Leadership Speeches

Mr. Zhao Jianjun, Deputy General Manager of Jiangsu Lihua Biotechnology

Mr. Zhao Jianjun stated that Lihua has always attached great importance to the improvement of employees' professional capabilities. This cooperation with Hippocrates on the employee training system project will build a professional learning platform for Lihua and drive the company's talent development and business growth to new heights. "We look forward to leveraging Hippocrates's cutting-edge technology to build an efficient training system that meets the internal learning needs of employees and helps the team enhance their capabilities," he said. At the same time, he expressed the hope that this cooperation will serve as an opportunity to optimize collaboration processes, break information barriers, and achieve efficient integration and allocation of resources.

Mr. Xiao Liang, Chairman of Hippocrates

Mr. Xiao (Ph.D.) introduced that both parties are member units of the CRO Branch of China Pharmaceutical Quality Management Association and have accumulated in-depth cooperation experience in the field of pharmacovigilance. He emphasized that this project is a new opportunity to deepen cooperation, and he looks forward to taking this as a link to build a closer and more stable strategic partnership for resource sharing and complementary advantages.

When talking about Hippocrates's business philosophy, Mr. Xiao explained: "Hippocrates has always adhered to the development concept of 'technology as the foundation, warmth as the soul', persisted in customer-centricity, and regarded helping customers succeed as its core mission. We are not only committed to providing cutting-edge technical solutions but also focus on conveying management concepts in the service process, working with customers to meet challenges and grow together."

Finally, regarding this project, Mr. Xiao put forward clear requirements, emphasizing that on the premise of strictly adhering to the timeline and ensuring the project is delivered on schedule, the delivery quality should be further improved to create high-quality results that are both practical and forward-looking, setting a new benchmark for future cooperation between the two parties.

04  About OwlTrust® (OwlTrust®) Digital Platform

As Hippocrates's core digital platform, OwlTrust® (OwlTrust®) is developed by a team of GMP industry and digital experts, and strictly complies with international and domestic standards such as GMP (Good Manufacturing Practice), cGMP (current Good Manufacturing Practice), FDA 21 CFR Part 11, and relevant regulations of NMPA (National Medical Products Administration).

The TMS system customized for Nantong Lianya Pharmaceutical Co., Ltd. this time is developed based on the "compliance gene" and "global adaptability" of the OwlTrust® platform. It supports multi-language learning interfaces, cross-border data synchronization, and electronic signature traces. It not only meets the FDA's requirements for traceable training records but also adapts to the NMPA's compliance training management standards. At the same time, it recommends position-specific courses through intelligent algorithms, balancing compliance and learning accuracy.

05 Introduction to Both Parties

About Jiangsu Lihua Biotechnology

Baihua Pharmaceutical (SH: 600721) is a leading enterprise in the  field of pharmaceutical R&D, with core technology platforms such as sustained-release technology and targeted drug delivery systems. The number of generic drug filings in the chemical pharmaceutical sector has ranked among the top in the industry for many years. The company has well-equipped international advanced R&D laboratories, which can carry out pharmaceutical research on hundreds of projects simultaneously. It has accumulated more than 400 domestic registered production approvals and clinical trial approvals, and obtained 79 authorized patents, demonstrating strong technical strength and R&D capabilities.

Jiangsu Lihua Biotechnology is a wholly-owned subsidiary of Huawei Pharmaceutical, which is under the Baihua Pharmaceutical Group. It is a professional CRO company that provides comprehensive new drug clinical development services for domestic and foreign pharmaceutical enterprises and biopharmaceutical companies, including drug registration affairs, design and organization of Phase I-IV clinical trials, medical support, project management, preclinical research consulting, data management, and biostatistics.

About Hippocrates

Named after Hippocrates, the father of ancient Greek medicine, Hippocrates has over 20 years of industry experience. The company started with GMP compliance consulting and has grown into a leading provider of pharmaceutical digital solutions in China. We have participated in the drafting of national GxP digital standards and possess strong capabilities in both consulting and independent R&D. Our products comply with GxP standards and meet the regulatory requirements of global authorities such as the NMPA, FDA, EMA, and WHO. Our self-developed QMS, DMS, and TMS suites rank among the top tier in China. We also offer VDR, eSIGN, PVS, EBR, WMS, CGT, and eMAH solutions, along with one-stop services covering compliance control, data governance, and CSV validation, supporting both group-level and global deployment. Our clients include leading domestic pharmaceutical companies, benchmark biotech enterprises, and multinational pharmaceutical companies. To date, we have helped hundreds of companies achieve zero-defect audits, empowering pharmaceutical enterprises in digital transformation, cost reduction, efficiency improvement, and global growth.