Amid the in-depth integration of digitalization, compliance and conglomerate development in pharmaceutical R&D, Jiangsu Hengrui Pharma Co., Ltd. (Hengrui Pharma, 600297.SH) entered into an in-depth strategic cooperation with Shanghai Hippocrates Health Technology Co., Ltd. to launch the clinical Training Management System (TMS) project.
The initiative is a key move for Hengrui Pharma to improve its GxP compliance system and advance its strategy of one unified GxP compliance platform, one unified unstructured content platform, and one unified AI infrastructure platform. It also marks a solid step forward in digital training management construction under GCP and GVP. By building an integrated, high-compliance training system, Hengrui Pharma will consolidate talent and compliance foundations for standardized clinical R&D, supporting its dual-driven strategy of technological innovation and internationalization.
01 Project Background
As a leader in China’s innovative pharmaceutical industry, Hengrui Pharma focuses heavily on clinical R&D and applies GCP and GVP compliance across the entire drug development chain, with rich product pipelines in oncology, anesthesia, imaging, endocrinology and other therapeutic areas.
With global business expansion and growing R&D teams, cross-department and cross-site collaboration demands keep rising, requiring higher professional competence, standardized compliance operations and efficient training management. Traditional training suffers from fragmented workflows, data silos and poor role-matching, bringing manual management risks that need digital rectification.
Hengrui Pharma urgently requires a group-oriented training platform that meets dual GCP/GVP compliance, enables full-process traceability, monitoring and data analysis, and integrates seamlessly with existing ECM, CTMS, eTMF and other systems. The cTMS project responds precisely to such demands. It unifies training standards for all clinical roles, provides customized learning paths for clinical research and pharmacovigilance, and realizes full-lifecycle compliant management of training documents and records linked to the enterprise unstructured content platform.
02 Core Project Planning
Both parties set up a joint project team and conducted in-depth discussions on building a GCP/GVP-compliant training framework, multi-system integration, group management adaptation, system compliance verification and cross-site collaboration. Clear timelines, milestones and collaborative mechanisms were defined, together with standardized communication and quality control protocols.
Following international norms including ISPE GAMP5, FDA 21 CFR Part 11, EU GMP Annex 11 and NMPA guidelines, the team will deliver end-to-end implementation covering requirement research, blueprint design, development, validation, launch training and after-service support. Regular weekly reports, routine meetings and milestone reviews will be adopted, with special working groups tackling multi-system integration and group permission control.
Full CSV validation including URS, VP, RA, IQ, OQ and PQ will be completed in line with Hengrui Pharma’s GCP DMS standards. The system will seamlessly connect with ECM, CTMS, eTMF, HR and WeCom, forming a unified digital ecosystem for clinical R&D.
03 Leadership Remarks
Hengrui Pharma Representative
Compliance is regarded as the bottom line of development at Hengrui Pharma. GCP/GVP training is critical to ensuring R&D quality and standardizing workflows, and an essential part of building the unified GxP platform. Traditional training can no longer meet the demands of compliance, standardization, efficiency and group-wide management.
Hengrui Pharma needs a digital training platform covering both GCP and GVP, adaptable to group operation and compatible with existing business systems, enabling precise role-based training and integrated management of training records and clinical quality documents.
Hippocrates boasts rich experience and proven solutions in pharmaceutical compliance training and clinical digitalization. The cooperation will build a standardized training system matching GCP/GVP requirements, realize automatic training allocation, record archiving linkage with ECM, and personnel data synchronization with CTMS. It will embed compliance awareness into daily clinical work and complement Hengrui Pharma’s GxP document management system.
The cTMS launch represents the digital upgrading of clinical training management and an important step in improving the GxP platform. Hengrui Pharma expects closer collaboration with Hippocrates in digital compliance, talent development and AI-enabled training, to jointly drive high-quality clinical R&D and international layout.
Hippocrates Project Leader
Hippocrates highly recognizes Hengrui Pharma’s leading position in innovative drug R&D and rigorous compliance pursuit. Hengrui Pharma’s high-standard GCP/GVP governance and group digital strategy align perfectly with Hippocrates’ mission of Creating Health Value with Technology. Hengrui Pharma’s “Three Unifications” strategy sets an industry benchmark, and the cTMS project marks deep collaboration in GxP compliance.
Beyond delivering a functional system, Hippocrates aims to build a user-friendly, compliant, secure and intelligent platform tailored to clinical scenarios. It will design standardized training matrices and curriculum systems under GCP/GVP, achieve seamless system integration, establish hierarchical group permissions and full audit trails, and link with the unstructured content platform for unified document and training record management.
A senior expert team will strictly follow pharmaceutical compliance rules and Hengrui Pharma’s project management specifications, complete full-process quality control and CSV validation, and deliver on milestones. The project will become a new industry benchmark for GCP/GVP digital training and support Hengrui Pharma’s GxP platform improvement.
04 About OwlTrust Digital Platform
Developed by GMP and digital experts, OwlTrust strictly complies with ISPE GAMP5, FDA 21 CFR Part 11, EU GMP Annex 11 and NMPA regulations, featuring mature compliance framework construction, multi-system integration and group operation capabilities.
The customized cTMS for Hengrui Pharma inherits OwlTrust’s compliance and industry adaptability. It integrates dual GCP/GVP requirements with dedicated courses, training matrices and assessment mechanisms, and interconnects with ECM, CTMS, eTMF and HR systems for automatic data synchronization and integrated record archiving, fully meeting electronic signature and audit trail regulations.
The system supports online training, offline courses and self-learning registration, equipped with version-controlled course management, anti-cheating exams, electronic signatures and full audit trails. It adopts multi-layer security protection including AK/SK authentication and AES encryption. Supporting independent and collaborative management across multiple sites, it enables classified data governance and precise authorization. Reserved AI interface allows future intelligent demand analysis and content recommendation, aligning with Hengrui Pharma’s unified AI infrastructure strategy.
05 Company Profile
About Hengrui Pharma
As a benchmark innovative pharmaceutical enterprise in China, Hengrui Pharma focuses on R&D, production and sales, owning rich product pipelines in major therapeutic fields. It implements GCP, GVP and GMP throughout clinical development and advances the three-platform strategy to build an integrated digital and compliant R&D system supporting multi-site group collaboration. With strong R&D strength and strict quality control, Hengrui Pharma leads domestic pharmaceutical innovation and delivers high-quality innovative medicines worldwide.
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.
