Building Evinova's Unify China Region Service from 0 to 1 Based on Amazon Web Services Life Sciences Industry Solutions

A clinical trial app that allows patients to complete medication feedback from home, a smart watch that can transmit heart rate data in real time—these scenarios were mere imagination a decade ago, but are now everyday tools in pharmaceutical R&D departments.

Behind this change lies a fundamental transformation in clinical trial models. In the traditional model, subjects needed to regularly visit designated institutions, queue for registration, and complete examinations within fixed time windows. Now, mobile applications, wearable devices, and remote monitoring have transformed data collection into something "embedded in life": patients check their daily symptoms on an app before bed, their watch automatically uploads overnight oxygen saturation curves in the morning, and electronic Clinical Outcome Assessment (eCOA) questionnaires appear at the patient's convenience. Pharmaceutical companies no longer receive "laboratory reports", but rather a continuous, dynamic health trajectory.

In this trend, Evinova, a separate health tech business within the AstraZeneca group focusing on AI-native life science digitalization solutions, has productized capabilities accumulated through real clinical R&D and extended them to more life science enterprises. It has already delivered improvements in clinical trials across sponsors in over 50 countries globally. Its core product, Unified Trial Solution (Unify), seamlessly connects patients, sites, and sponsors. Through therapeutic domain-specific intelligent solutions, innovative digital clinical endpoints, smart wearable devices, remote patient monitoring, and eCOA, among other approaches, Unify enables 70% of key clinical trial assessment items—including blood pressure, oxygen saturation, and respiratory rate—to be completed at home. While reducing burden on patients and institutions, it enables better monitoring and management of drug toxicity, integrating all trial-related activities on a unified platform to provide an all-in-one service.

However, when Evinova planned to localize and deploy the Unify platform in China to advance the development of China's digital clinical trial ecosystem, it encountered a series of localization challenges:

• Security and Compliance: Unify needs to collect subject health data through patient-facing apps, wearable devices, and remote monitoring, while supporting key activities like eCOA. How to meet requirements for personal information protection, sensitive information management, data encryption, audit trails, and compliance verification was the first question Unify's China deployment had to address.
• Resilience and Elasticity: During decentralized clinical trials, subject population sizes, data upload frequencies, device connection volumes, and monitoring requirements vary across different projects. Unify must not only handle routine data flows, but maintain stable operations during traffic fluctuations, event triggers, and peak processing scenarios.
• Future Scalability: As a digital clinical trial platform serving life science enterprises, Unify must continuously onboard new scenarios across different pharmaceutical companies, clinical trials, and business processes. It must ensure data isolation between different tenants and projects while supporting rapid launch of new trial projects and leaving sufficient expansion capacity for future product iterations.

Therefore, Evinova sought a technical foundation that could simultaneously meet requirements for life sciences industry compliance, cloud-native elasticity, and scalability. After conducting comprehensive evaluations over more than a year, Evinova chose to partner with Amazon Web Services to advance Unify's China region service development.

To address clinical trial security and compliance requirements, Amazon Web Services provides technical foundations for Unify's compliant China deployment through native capabilities such as data encryption, network isolation, end-to-end monitoring, and audit trails. At the same time, Amazon Web Services's rich portfolio of cloud services covers multiple dimensions including compute, storage, networking, containers, and monitoring, supporting Unify's flexible scaling based on different clinical trial projects' data volumes, access peaks, and business processes. Amazon Web Services's long-standing experience serving multinational enterprises and life science customers, combined with coordination among Amazon Web Services China team, global team, solution architects, industry team, support team, and partners, effectively enables Evinova to efficiently complete the entire process from solution evaluation, architecture design to local deployment. Furthermore, Amazon Web Services can meet Evinova's requirements for globally consistent architecture, reducing complexity in subsequent version iterations, project onboarding, and cross-region collaboration.

"For a product like Unify that serves global digital clinical trial scenarios, China region deployment is not simply technical deployment, but requires striking a balance among product capabilities, clinical trial processes, local compliance requirements, and long-term scalability. Amazon Web Services has helped us translate security compliance, data protection, system stability, and architecture consistency requirements into clear, actionable technical paths, enabling Unify to more efficiently complete the transformation from global capabilities to China localization while reserving expansion space for more digital clinical trial scenarios in the future."

– Huang Tianjiao, Evinova China Region Unify Product Lead

When Evinova decided to deploy the Unify platform in China in 2024, lacking an established China team at that time, it was unfamiliar with local regulatory environment, company establishment procedures, and cloud cost optimization management (FinOps) frameworks. Amazon Web Services China team, in coordination with the global team, started providing support, including fundamental compliance procedures such as business registration, and gradually helped Evinova transform Unify from global capabilities into a China region available service, providing support throughout the zero-to-one localization business development process.

In this process, Evinova needed to ensure that clinical trial-related data was collected, stored, processed, and tracked safely and stably while meeting GxP (Good Practice Guidelines), computerized system validation, data localization, sensitive information protection, and China's Level 3 information security classification standards and other local compliance requirements.

To this end, Amazon Web Services provided life sciences industry solutions with coordinated participation from China and global teams, offering continuous support around compliance requirements, service selection, architecture evaluation, and deployment pathways. Working together with Evinova, Amazon Web Services translated numerous security and compliance requirements into executable technical control points such as auditing, backup, monitoring, encryption, access control, and secure isolation to be further implemented in architecture configuration, service selection, and operational management processes. Additionally, Amazon Web Services service teams, combining local industry best practices, helped Evinova clarify implementation pathways for compliance requirements such as Level 3 information security classification, providing corresponding architecture references and configuration recommendations and enabling Evinova to more efficiently advance China region deployment of global product capabilities.

During decentralized clinical trials, different trial projects may have varying subject populations, data upload frequencies, device connection volumes, and remote monitoring requirements. Data flows from patient-facing apps, wearable devices, and eCOA assessments may also fluctuate. This requires Unify's event flow engine to continuously receive data from subject endpoints while promptly completing status determination and business triggering upon data system entry. When subjects complete assessments or devices upload health metrics at home, the system must complete data flows; if anomalies appear in any metric, the system must promptly notify research teams, pharmaceutical companies, or medical institutions.

Leveraging Amazon EKS's elasticity and container management capabilities, Unify runs core microservices such as event flow engines, document databases, and identity authentication services in a unified container environment. Core data storage resides in a data lake built on Amazon S3, event processing status and system operation metrics are unified monitored and alarmed by Amazon CloudWatch, while end-to-end data encryption is secured through Amazon KMS encryption key management, maintaining stable operations during routine collection, peak upload, and anomalous event trigger scenarios.

Meanwhile, since Unify provides services to different pharmaceutical companies and clinical trial projects, data isolation between multi-tenants is an important component of security and compliance. Leveraging Amazon Web Services account and Amazon EKS cluster-level isolation, Evinova configures relatively independent operating resources for different tenants and projects, ensuring data isolation while sustaining Unify's core services with unified cloud-native architecture. This transforms security compliance from a one-time pre-launch check into a complete mechanism spanning data hosting, service operation, tenant isolation, and continuous verification.

Unify operates in multiple countries and regions globally. If the China region architecture differs significantly from the global system, each new feature introduction, version upgrade, or project expansion could bring additional localization modifications and cross-team communication costs. By running on Amazon Web Services, Evinova maintains a globally consistent architecture, enabling Unify's China region service to meet local market requirements while maintaining the same operations system as global products. When the global team advances product updates or new clinical trial solutions onboard, China region services can adapt on more familiar technical pathways, reducing repetitive modifications and exception handling.

"With Amazon EKS, Unify can flexibly configure operating resources according to different trial project scales and business loads, simultaneously supporting existing patient data collection and business processes while reserving expansion space for more future clinical trial projects and digital capabilities to land in China."

– Huang Tianjiao, Evinova China Region Unify Product Lead

With Amazon Web Services support, Evinova has completed Unify China region infrastructure development from zero to one, achieving multi-dimensional improvements in compliance support, operational stability, and long-term expansion capabilities:

• Establishing Solid Compliance Foundation: Unify's China region service has received verifiable technical support in data encryption, access control, operation monitoring, and audit trails, laying a foundation for secure and compliant clinical trial data use in China.
• Enhanced Operational Stability: Based on Amazon EKS's cloud-native architecture, Unify can more flexibly handle dynamic data flows in digital clinical trials, supporting stable operations during routine collection, peak upload, and anomalous event trigger scenarios.
• Improved Future Expansion Efficiency: By maintaining globally consistent architecture, Evinova can reduce repetitive modification costs for Unify's China region service during new project onboarding, version upgrades, and localization adaptation, enabling more clinical trial projects and digital capabilities to land more efficiently.

At the same time, Evinova has adopted Amazon Web Services Enterprise Support, with Amazon Web Services providing a comprehensive service team composed of customer teams, solution architects, industry teams, support teams, and partners, spanning architecture reviews, PoC verification, technical consulting, and daily operations. This investment reflects Amazon Web Services's customer-first service philosophy: when customer businesses enter an entirely new field, Amazon Web Services support extends beyond technical tools to accompanying customers through every step from nothing to something.

Looking ahead, Evinova will continue perfecting cloud-native infrastructure for digital clinical trials, supporting more patient data collection, remote monitoring, event flow, and research collaboration needs. On this foundation, Evinova will also leverage Amazon Web Services's secure, resilient, and scalable cloud foundation to continuously explore more digitalization and AI-related capabilities in life science scenarios, reserving more sufficient technical space for future more digital clinical research products and services.