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Introduction
For over four decades, Epic has been at the forefront of healthcare and information technology, bridging the gap between people and systems worldwide. Epic's innovative solutions empower individuals and communities to actively engage in their own health, supporting clinical, financial, and operational aspects of hospitals and health systems.
Objective
Enable scalable, decentralized clinical trials while optimizing trial performance through secure, participant-friendly technology.
Background
Evolution RX is a pioneering clinical research platform dedicated to enhancing clinical trial performance through a unified technology framework. The platform’s mission is to transform trial management by optimizing participant engagement and retention. With the growing shift towards decentralized clinical trials (DCTs), Evolution RX needed a solution to support large-scale trials while ensuring data security, scalability, and ease of access through Single Sign-On (SSO) capabilities.
Softwise Solutions partnered with Evolution RX to implement a robust AWS-based infrastructure tailored to meet these complex demands, delivering a seamless, secure, and scalable platform to power modern clinical research.
Challenges Faced by Evolution RX
- Scalability: The platform required the capacity to scale in real-time to accommodate large, variable data loads from diverse trial phases.
- Participant Retention: The need to improve user experience to keep participants engaged, minimizing drop-offs and data inaccuracies.
- Data Security and Compliance: Clinical trials generate sensitive data that must comply with stringent regulatory standards, making data security a top priority.
- Cost Management: A need to control operational costs without compromising the quality of trial management.
Solution Design and AWS Architecture
Softwise Solutions designed and deployed a comprehensive AWS architecture to meet these demands. By leveraging AWS’s wide array of services, we created a decentralized, flexible, and secure ecosystem capable of supporting the Evolution RX platform across all stages of the clinical trial lifecycle.
Key AWS Services Used
- Amazon EC2 (Elastic Compute Cloud): Hosts the Evolution RX platform, providing scalable compute power. With auto-scaling, the platform dynamically scales based on real-time demand.
- Amazon RDS (Relational Database Service): Manages Evolution RX’s trial data with high availability, automating tasks such as backups, patching, and scaling.
- Amazon S3 and Amazon CloudFront: Offers scalable, secure storage for clinical data, with global content delivery for rapid access worldwide.
- AWS SSO (Single Sign-On): Enables secure, unified access across applications, enhancing user experience and boosting participant engagement.
- Amazon CloudWatch and AWS Lambda: Monitors platform performance and automates tasks, minimizing operational costs.
Solution Architecture
The architecture integrates EC2, RDS, and S3 as core components, with CloudFront delivering cached content globally. AWS SSO provides secure access control, and CloudWatch and Lambda handle monitoring and automation. Security is further enhanced with VPCs, security groups, and IAM roles, ensuring comprehensive data protection.
Implementation Process
- Planning and Architecture Design: Collaborated with Evolution RX to design a HIPAA-compliant AWS architecture tailored to clinical trial workflows.
- Database and Application Migration: Migrated existing databases to Amazon RDS with minimal downtime, using AWS Database Migration Service.
- Scaling and Testing: Configured auto-scaling policies and conducted extensive testing for performance, security, and compliance.
- Final Deployment and SSO Integration: Launched the solution with AWS SSO integration, enabling seamless access for participants and researchers.
- Ongoing Support and Optimization: Continually monitor with CloudWatch and optimize the platform, fine-tuning auto-scaling and improving cost efficiency.
Results and Benefits
- Improved Trial Performance: Enhanced platform responsiveness improves data accuracy and participant retention.
- Enhanced Security and Compliance: Secure infrastructure enabling compliance with HIPAA, GDPR, and 21 CFR Part 11.
- Cost Efficiency: AWS’s pay-as-you-go model and Lambda automation reduce infrastructure costs by an estimated 30%.
- Scalability and Flexibility: The platform can dynamically scale to meet trial requirements.
- Improved Participant Experience: Streamlined AWS SSO access encourages higher participant engagement.
Client Testimonial
“Softwise Solutions’ AWS expertise has transformed our platform, enabling us to run large-scale, decentralized clinical trials while maintaining data security and regulatory compliance. The architecture they designed allows us to scale effortlessly, keeping participants engaged and committed, which is essential for successful research outcomes.” — Evolution RX CEO (https://evolutionrx.us/)
Conclusion
By partnering with Softwise Solutions and implementing an AWS-based infrastructure, Evolution RX has revolutionized its approach to clinical trial management. This robust cloud architecture supports Evolution RX’s commitment to decentralized, secure, and efficient trials, ensuring both operational excellence and participant satisfaction. With AWS, Evolution RX is well-positioned to meet the growing demands of the clinical research industry, driving impactful research outcomes.
