Transforming REMS Surveys with Flexible and Cost Effective Solutions

Overview 

The Client 

A leading global clinical research organization (CRO) aimed to conduct Risk Evaluation and Mitigation Strategy (REMS) surveys—an essential process for ensuring the safe use of medications with serious risks. However, they faced challenges in finding a reliable partner with the expertise to navigate the specific REMS survey requirements while ensuring compliance with 21 CFR Part 11 and maintaining the highest levels of data protection. The CRO required a cost-effective, flexible, and scalable solution that met FDA regulations and allowed for expedited setup. 

Product Overview 

Dacima’s REMS survey module addresses these concerns through a robust 3 stack architecture that is compliant with the most stringent regulatory standards and provides data security, integration capabilities and helps in optimizing survey workflows.

Challenges addressed 

• Regulatory Compliance: Adheres to 21 CFR Part 11
• Data Security: Uses secure, token-based access with segregated architectures to protect PII
• Validation & Auditing: Fully validated with audit trails for FDA inspections 
• Scalability & Flexibility: Manages REMS surveys across multiple groups with customizable workflows
• Cost-Effective: Offers high functionality at lower costs than legacy systems
• User-Friendly: Features an intuitive platform for seamless survey management

Solution Overview 

Dacima’s REMS Survey module combining innovation, compliance, and affordability with advanced features. Dacima’s robust platform enabled the CRO to simplify the process of managing all REMS surveys while ensuring efficiency and full regulatory compliance. 

The Dacima Difference 

• FDA 21 CFR Part 11 Compliance: Secure, regulatory-approved solution ensuring full compliance
• Multi-Survey Capabilities: Manage multiple participant groups
• Quick Deployment: Fully operational in under four weeks for fast project execution
• Cost-Effective: Delivers high-value functionality at a competitive price
• Advanced Reporting Tools: Gain real-time analytics and survey data insights
• Automated Notifications: Ensuring timely responses and data collection
• US tech support coverage: Instant assistance available during EU business hours

Results and Outlook 

Dacima delivers industry-leading performance with advanced features tailored for REMS surveys—without the high costs of larger, branded platforms. Designed for efficiency, our solution ensures seamless operations, 21 CFR Part 11 compliance, and robust data security. Trusted by industry leaders, Dacima empowers teams to optimize workflows, reduce costs, and confidently navigate the complexities of REMS requirements while maintaining full regulatory compliance. 

Reach out today to streamline your REMS Survey!