Amid the profound integration of digitalization and globalization in pharmaceutical R&D, PIXEL WISER and HIPPOCRATES (Shanghai Hippocrates Health Technology Co., Ltd.) have entered an in-depth partnership to jointly launch the Training Management System (TMS) digital project. The project kickoff meeting was successfully held recently. This milestone marks a crucial step for PIXEL WISER in the digital talent development of European clinical research, and consolidates the compliance foundation for its global independent third-party medical imaging service layout.

01 Project Background

Founded by seasoned industry professionals in 2022, PIXEL WISER is a professional independent third-party medical imaging review center (IRC). Its core team consists of elites from leading enterprises, with an average working experience of over 10 years. The company boasts more than 200 blinded independent radiological review (BIRC) experiences focusing on oncology projects, and over 50 involved drug R&D projects have obtained approvals from major global regulatory authorities including FDA, EMA, NMPA and PMDA, gaining solid professional strength and international recognition in global clinical imaging services.

With the continuous expansion of overseas clinical research business dominated by European markets, higher requirements have been raised for team professionalism, compliance execution and cross-regional collaboration efficiency. Traditional training modes can no longer meet core demands including standardized overseas team cultivation, accurate implementation of clinical compliance regulations and customized training for diversified roles. Manual operation also brings management risks that need to be eliminated via digital means.

The launch of the TMS digital project serves as a core initiative catering to global business expansion. By establishing a digital training management system complying with European clinical research standards, the partnership unifies overseas training criteria and aligns regulatory requirements with job responsibilities. Customized learning paths are designed for different clinical positions to help staff proficiently grasp European pharmaceutical regulations and professional imaging service norms. Standardized and compliant talent development underpins the corporate vision of empowering innovative drug research with intelligent imaging and the global business strategy.

02 Project Kickoff Meeting

Jointly hosted by both parties, the kickoff ceremony aims to ensure efficient implementation and high-quality delivery of the TMS project. Presided over by Shen Yiyi, the meeting gathered all project members from PIXEL WISER and HIPPOCRATES. In-depth discussions were conducted covering standardized training for overseas clinical teams, GDPR data privacy compliance implementation, key points of Azure cloud overseas deployment and full-process CSV validation control. A 2-month implementation schedule, phased milestones and collaborative management mechanisms were confirmed, laying a solid foundation for steady project advancement.

Subsequent special management meetings were held by project managers and key users to refine follow-up work plans, address difficulties and unify work consensus.

03 Leaders' Remarks

Dong Jing, Project Director of PIXEL WISER, stated that building a professional and compliant global clinical imaging team has been the core development principle since the company’s founding, consistent with the mission of empowering innovative drug R&D with intelligent imaging.

"Our business roots in China and serves the globe, with Europe as a core overseas market. Apart from sophisticated imaging technologies, team members must be well-versed in local regulatory rules including EMA guidelines and GDPR. Conventional training models fail to satisfy the demand for compliant, standardized and efficient overseas talent cultivation."

She expressed high expectations for the collaboration with HIPPOCRATES: "As a pioneer in life science digital solutions, HIPPOCRATES possesses rich experience in pharmaceutical digital training and overseas compliant system deployment. It will help us build a full-cycle training management system adapted to European clinical scenarios. The system can automatically assign targeted training and assessment content based on job roles, and ensure privacy protection and security management of training data in line with GDPR. It will boost learning efficiency, embed compliance awareness into every position and mitigate operational risks."

"This project signifies the digital and compliant transformation of our overseas talent training system. We look forward to smoother cooperation and further joint exploration in digital compliance management and global team development in the future," Dong added.

Xu Chao, Project Director of HIPPOCRATES, highly recognized PIXEL WISER’s outstanding achievements in global clinical imaging services. He commented that PIXEL WISER has established itself as a credible IRC provider with experienced teams and abundant project track records. Its strict compliance pursuit and global development layout resonate with HIPPOCRATES’ original aspiration of creating health value through technology.

He noted that the TMS project kicks off in-depth bilateral cooperation. "We aim to deliver not only functional software, but also a practical, compliant and secure digital platform tailored to PIXEL WISER’s overseas business. The system will adopt GDPR-aligned data privacy frameworks, deploy multi-environment infrastructure on Azure cloud, and develop role-based training modules to fuel the capability growth of overseas teams."

Xu clarified delivery objectives: "Our senior expert team will strictly follow the 2-month timeline and adhere to full-process quality control and CSV validation standards to guarantee smooth system launch. We strive to set a new benchmark for digital training cooperation in overseas clinical research."

04 Introduction to OwlTrust Digital Platform

Developed by GMP and digital experts, OwlTrust, HIPPOCRATES’ core digital platform, complies rigorously with international and domestic specifications including GMP, FDA 21 CFR Part 11, EU GMP Annex 11, ISPE GAMP5 and NMPA guidelines, featuring mature overseas compliant deployment and data privacy protection capabilities.

The customized TMS system for PIXEL WISER inherits OwlTrust’s inherent compliance strengths and global adaptability. Supporting bilingual Chinese and English interfaces, it fits daily operation of European teams. Deployed across testing, validation and production environments on Azure cloud, the platform adopts multi-layer security measures including data encryption, hierarchical access control and operational audit tracking to comply with GDPR regulations. It realizes automatic matching of training assessments for different clinical roles, supports online and offline hybrid training modes, and manages training archives throughout their lifecycle. Balancing compliance, professionalism and personalized learning, the system fully satisfies training management needs of PIXEL WISER’s international workforce.

05 Company Profiles

About PIXEL WISER

Established in 2022, PIXEL WISER is a professional independent third-party medical imaging review center committed to empowering global innovative drug R&D with intelligent imaging. Its elite team averages over 10 years of industrial experience. The company has completed more than 200 oncology-focused BIRC assignments, with over 50 participated drug development projects approved by mainstream global regulatory bodies. Boasting professional technologies and stringent compliance management, PIXEL WISER stands as a trusted partner in global clinical research imaging services.

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.