Project Launch | Hengrui Medicine Joins Hands with Singodi to Launch TMS Project: GCP/GVP Dual Compliance Consolidates the Foundation of Training Management
Against the wave of deep integration among digitalization, compliance and group-oriented development in pharmaceutical R&D, Jiangsu Hengrui Medicine Co., Ltd. (“Hengrui Medicine”) has entered into an in-depth strategic cooperation with Shanghai Singodi Health Technology Co., Ltd. (“Singodi”) to jointly launch the Clinical Research Training Management System (cTMS) project.
This project launch is an important measure for Hengrui Medicine to improve its GxP compliance system and advance its strategy of “One Unified GxP Compliance Platform, One Unified Unstructured Content Platform, One Unified AI Foundation Platform”. It also marks a key step forward in the digital construction of training management in the GCP/GVP sector. By building an integrated, highly compliant training system, Hengrui Medicine will consolidate a dual foundation of talent and compliance for the standardized and regulated development of its entire clinical R&D process, supporting the implementation of its dual-engine strategy of technological innovation and internationalization.
01 Project Background
As a leading enterprise in China’s innovative pharmaceutical industry, Hengrui Medicine has long been deeply engaged in clinical R&D, integrating dual compliance requirements of GCP (Good Clinical Practice) and GVP (Good Pharmacovigilance Practice) throughout the entire drug R&D chain. It has built a rich portfolio of innovative products in oncology, anesthesia, contrast media, endocrinology and other therapeutic areas.
With the global expansion of clinical research and continuous growth of the R&D team, the demand for collaborative management across multiple locations and departments (including Lianyungang, Shanghai, etc.) has increased significantly, raising higher requirements for the professional competence, compliance operation standards and training management efficiency of clinical research personnel.
Traditional training models suffer from fragmented processes, data silos, and insufficient precision matching between training and job roles. Management risks caused by manual operations urgently need to be avoided through digital means. Meanwhile, the enterprise urgently needs a training management system that meets both GCP/GVP compliance requirements and supports group-based management, enabling full traceability, monitoring and analysis of the entire training process, and efficient collaboration with existing systems such as ECM (Enterprise Content Management), CTMS and eTMF, so that compliance training is deeply integrated into the full lifecycle management of clinical R&D.
The launch of the TMS project is a core initiative for Hengrui Medicine to respond to the needs of digital, compliant and group-oriented development in clinical R&D. By establishing a digital training management system aligned with GCP/GVP dual compliance standards in the pharmaceutical industry, the company will unify training standards for all clinical R&D positions, achieve precise matching between regulatory requirements and role responsibilities, and customize dedicated learning paths for different business scenarios such as clinical research and pharmacovigilance. This will enable the team to quickly master core content including GCP/GVP regulations and clinical research operation standards. Ultimately, the standardized and compliant improvement of talent capabilities will support the high-quality development of innovative drug R&D, while linking with the enterprise’s unified unstructured content platform to realize full-lifecycle compliant management of training documents and records.
02 Core Planning for Project Launch
To ensure efficient and high-quality delivery of the TMS project, Hengrui Medicine and Singodi have set up a dedicated joint project team. Based on Hengrui’s mature project management system, the two sides have conducted in-depth discussions on core topics including the construction of a GCP/GVP dual compliance training system, seamless integration of multiple systems, adaptation to group-wide training management, system security and compliance validation, and collaborative management across multiple regions and departments. The project implementation cycle, milestones for each phase, and collaborative management mechanisms have been defined, with a complete communication strategy and quality control system established.
Centered on Hengrui Medicine’s actual business needs, the joint team will carry out full-process implementation covering demand investigation, blueprint design, system development, testing and validation, online training and operation support, in accordance with international and domestic authoritative compliance standards including ISPE GAMP5, FDA 21 CFR Part 11, EU GMP Annex 11 and NMPA regulations.
During implementation, communication mechanisms such as weekly project reports, regular meetings and milestone reviews will be strictly enforced. Special communication and workshop mechanisms will be established for key and difficult issues including multi-system integration and group-wide authority control, to refine work arrangements, align working ideas and gather synergy for project progress.
In addition, full-process validation including URS, VP, RA, IQ, OQ and PQ will be completed with reference to Hengrui Medicine’s GCP DMS implementation standards, ensuring the system not only fits actual business scenarios but also strictly complies with international and domestic compliance requirements. Seamless integration with ECM, CTMS, eTMF, HR, WeChat Work and other systems will be realized, creating an integrated digital management ecosystem for clinical R&D.
03 Leadership Speeches
A relevant project leader from Hengrui Medicine stated that compliance has always been the lifeline of the company’s development. GCP/GVP compliance training in clinical R&D is a critical link to ensure drug R&D quality and standardize R&D processes, and also an important part of the company’s “Three Ones” strategy to build a unified GxP compliance platform.
“With the global development of our clinical research business and rising demand for cross-location and cross-department collaboration, traditional training models can no longer meet our needs for compliant, standardized, efficient and group-wide training management. We need a digital training management platform that covers both GCP and GVP, supports group management, and integrates seamlessly with existing business systems such as ECM and CTMS, so that compliance training is embedded in daily work, each position is matched with precise training content, and integrated compliance management of training records and clinical quality documents is achieved.”
Regarding the cooperation with Singodi, the leader expressed high expectations:
“Singodi, as a pioneer in digital solutions for life and health, has extensive professional experience and mature solutions in the construction of compliant training systems and digitalization of clinical R&D in the pharmaceutical industry. It can help us build a full-process training management system that meets GCP/GVP dual compliance requirements and adapts to Hengrui’s group management and multi-site collaboration needs.
For example, automatically matching training and assessment content for different clinical R&D positions, archiving training records linked with the ECM system, and synchronizing project personnel information with the CTMS system. This will not only improve the efficiency of training management, but also embed the compliance concept into every link of clinical R&D through systematic training, reduce manual operation risks in daily work, and complement the company’s GxP quality document management system.”
The leader emphasized:
“This is not only the implementation of a training system, but also the starting point for the digital and compliant upgrade of our clinical R&D training management system, and an important step in improving the company’s GxP compliance platform. We hope to take this opportunity to establish a smoother collaboration model with Singodi, and explore more cooperation possibilities in digital compliance management, clinical R&D talent capability development, and AI-enabled training management in the future, jointly promoting the high-quality development of the company’s clinical R&D and supporting the implementation of the dual-engine strategy of technological innovation and internationalization.”
The Singodi project leader first expressed high recognition of Hengrui Medicine’s industry achievements and compliance pursuit in innovative drug R&D:
“As a benchmark enterprise in China’s innovative pharmaceutical industry, Hengrui Medicine has always promoted clinical R&D with high standards and strict requirements. Its extreme pursuit of GCP/GVP dual compliance, digital and group-oriented development strategy are highly consistent with Singodi’s original aspiration of ‘Creating Health Value through Technology’. Hengrui Medicine’s ‘Three Ones’ strategy has set a benchmark for the digital and compliant development of the pharmaceutical industry. The cooperation on this TMS project represents in-depth collaboration between the two sides in the GxP compliance field.”
He stressed that the TMS project is an important start of in-depth cooperation between the two parties:
“We will not only build a ‘usable’ training management system for Hengrui Medicine, but a ‘practical, compliant, secure and intelligent’ digital platform tailored to its clinical R&D needs, meeting GCP/GVP dual compliance and supporting group-wide and multi-site collaborative management.
This includes designing training matrices and curriculum systems based on GCP/GVP compliance standards, realizing seamless integration with ECM, CTMS, eTMF and other systems, and establishing group-based hierarchical authority management and full-process audit trail systems. The system will truly become a ‘booster’ for improving the capabilities of Hengrui’s clinical R&D talents and a ‘guardian’ of clinical R&D compliance management, linking with Hengrui’s unified unstructured content platform to achieve integrated management of training content and clinical quality documents.”
Finally, the Singodi project leader clarified the project delivery objectives:
“We will assemble a senior expert team, strictly follow pharmaceutical industry compliance standards and Hengrui Medicine’s project management specifications, implement full-process quality management and CSV validation requirements, and advance the project according to established milestones to ensure high-quality system launch. We aim to make this project a new benchmark for digital collaboration in GCP/GVP dual compliance training management in the pharmaceutical industry, and help Hengrui Medicine build a more complete GxP compliance platform.”
04 About OwlTrust Digital Platform
OwlTrust®, as Singodi’s core digital platform, is developed by a team of GMP and digital experts. It strictly complies with international and domestic authoritative standards including ISPE GAMP5, FDA 21 CFR Part 11, EU GMP Annex 11 and NMPA GMP Appendices. It possesses mature capabilities in compliance system construction, multi-system integration, group management adaptation and multi-site collaborative operation, which are highly consistent with Hengrui Medicine’s GxP compliance management requirements.
The customized TMS system for Hengrui Medicine is developed based on OwlTrust®’s “compliance genes” and “industry adaptability”. It not only deeply integrates GCP/GVP dual compliance requirements to build targeted training courses, matrices and assessment systems, but also achieves seamless integration with ECM, CTMS, eTMF, HR, WeChat Work and other systems, ensuring automatic synchronization and data interconnection of project information, personnel information and training records, as well as integrated archiving management of training records with the ECM system, meeting the electronic signature and audit trail requirements of FDA 21 CFR Part 11.
Meanwhile, the system supports diverse training forms including online training, offline centralized courses and self-study registration, equipped with core functions such as multi-version document management, anti-cheating examinations, electronic signatures and full-process audit trails. A multi-level security protection system is established including AK/SK signature authentication, AES encrypted transmission and IP whitelist restriction.
To adapt to Hengrui Medicine’s group management needs, the system supports independent and group collaborative management across multiple locations and departments such as Lianyungang and Shanghai, realizing classified, graded, confidential and precise authorization of training data. It also reserves interfaces for AI large models, enabling intelligent analysis of training needs and intelligent recommendation of training content in the future, linking with Hengrui Medicine’s “Unified AI Foundation Platform” strategy. The system balances compliance, professionalism, intelligence and security to fully meet Hengrui Medicine’s training management needs in clinical R&D.
05 Company Profiles
About Hengrui Medicine
Jiangsu Hengrui Medicine Co., Ltd. is a benchmark innovative pharmaceutical enterprise in China, adhering to innovation as its core development strategy and focusing on drug R&D, production and sales. It has built a rich product pipeline in oncology, anesthesia, contrast media, endocrinology and other therapeutic areas.
The company has always integrated compliance management throughout the entire clinical R&D process, strictly following international and domestic regulatory standards such as GCP, GVP and GMP, and vigorously promoting the three major strategies of “One Unified GxP Compliance Platform, One Unified Unstructured Content Platform, One Unified AI Foundation Platform” to build an integrated digital and compliant R&D management system, supporting independent and group collaborative management across multiple locations and departments including Lianyungang and Shanghai.
With strong R&D capabilities, strict quality control and standardized operation management, Hengrui Medicine has become a leader in innovation and development in China’s pharmaceutical industry, providing more high-quality innovative drugs for patients.
About Hippocrates
“Hippocrates” is derived from the transliteration of “Hippocrates”, the father of western medicine. Upholding the original aspiration of “Creating Health Value through Technology”, Hippocrates focuses on digital services in the life and health sector (pharmaceuticals, medical devices, clinical research, etc.). With “Customer Success” as its core mission, it combines cutting-edge technology and industry expertise to provide customers with digital solutions in quality compliance and talent development, helping enterprises reduce costs, improve efficiency and enhance core competitiveness.
As a pioneer in digital solutions for life and health, Hippocrates has mature capabilities in compliant system construction, multi-system integration, group management adaptation and overseas compliance deployment in the pharmaceutical industry. It owns brands including Hippocrates Health and Ruilesen Consulting, and has served more than 200 pharmaceutical enterprises. With unified project management, implementation methodology and comprehensive quality assurance systems, Hippocrates has become an important partner for the digital, compliant and global development of pharmaceutical enterprises.
As an important strategic cooperation customer, Hippocrates will devote its best senior expert resources to Hengrui Medicine, strictly follow its project management and compliance validation standards, fully guarantee project implementation effects, and join hands with Hengrui Medicine to build a new digital benchmark for GCP/GVP dual compliance training management in the pharmaceutical industry, supporting Hengrui Medicine’s GxP compliance platform construction and the implementation of its dual-engine strategy of technological innovation and internationalization.
