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Top 5 Essential EDC Criteria for Medical Device Trials

5 Must-Haves While Choosing an EDC Platform for Your Next Trial

Rajesh Swamy Pothula

As 2023 wrapped up, clinical research is on the cusp of an exciting new era. AI-powered data analysis and real-time data are transforming the way we conduct studies. To stay ahead of the curve, choosing the right Electronic Data Capture (EDC) platform is more crucial than ever. But with a plethora of options available, what should be your top priorities while choosing an EDC?

5 Must-Haves for Your Next EDC Platform:

The below list consists of features which a new age EDC must have coupled with specific features.

1. Leverage the Power of AI: Auto-Pilot Tasks, Unleash Insights

Artificial intelligence is now part and parcel of the clinical trial. EDC software infused with AI can revolutionize your trials by:

  • Automated Study setup: From protocol design to case report form creation and CDASH coding; AI enables automated study setup and reduced build timelines 
  • Proactive query management: Identify and flag potential data inconsistencies in real time, preventing delays and ensuring data quality.
  • Predictive risk assessment: Leverage AI to predict potential safety issues or study setbacks, enabling proactive interventions.

2. Ease of Use: Built for You, Not Tech Geeks

Forget cryptic interfaces and endless training days. Your EDC should be as intuitive as your smartphone, built for researchers, not programmers. No more steep learning curves and integration headaches, just streamlined workflows and accelerated study progress.

  • Intuitive interface: Automated builds with in-built standards, intuitive navigation and minimal errors during data entry.
  • Role-based access and permissions: Tailored interfaces for different user roles (CRCs, investigators, etc.) to ensure data security and efficient workflows.
  • Days instead of weeks building CRFs: Choose a system with a standardized Global Library that lets you build forms in days, not weeks.

3. Unified Platform: Breaking Down Data Silos, Fostering Collaboration

Modern EDC platform provides end-to-end solutions, real-time dashboards and visualizations, allowing you to work across multiple applications seamlessly, aggregating information and providing a centralized interface for complete study oversight.

  • Embrace ePRO and CTMS Integration: Seek an EDC platform that seamlessly integrates with ePRO and CTMS, eliminating data silos and streamlining workflows.
  • Standardized Data Formats: Ensure the system supports relevant data formats like DICOM, HL7, and CDISC to facilitate data exchange with other systems.
  • Regulatory Compliance: Look for an EDC platform with specific validation for studies, following regulations like FDA 21 CFR Part 11, EU MDR/IVDR, and ISO 13485.

4. Powerful Features: Beyond the Basics

Look for an EDC equipped with advanced features like data loaders, custom reporting tools, and comprehensive analytics.

  • Advanced reports and visualization: Drill down into your data with powerful reports, interactive charts, and graphs to uncover hidden patterns and trends.
  • Data security and compliance: Choose an EDC system with robust security features and adherence to relevant data privacy regulations like GDPR and FDA 21 CFR Part 11.
  • Maximize Value, Not Costs: Choose an EDC platform that includes features like AI-enabled CDASH mapper, rSDV automation, Data Loader, AI Medical Coding and advanced dashboards as a standard.

5. Value for Money: Maximize Efficiency, Minimize Costs

Research budgets are precious, so choose an Electronic Data Capture (EDC) platform that delivers real value at every turn. Ditch outdated tools that drain resources and drag down productivity. Choose an EDC that works in tandem with you, maximizing efficiency and minimizing cost while delivering deeper insights.

  • Invest in efficiency, unlock savings: Powerful automation features, faster study setup, AI-powered tools, and streamlined processes deliver significant cost efficiencies – all at the cost of a traditional EDC.
  • Flexible pricing models: Choose a platform that aligns with your budget. Look for flexible pricing models and options that cater to your specific study needs and duration.
  • Don’t get stuck with pre-built reports: Choose a system that allows you to customize reports and delve deeper into device-specific data, gaining actionable insights for informed decision-making.

Remember, the right EDC platform is an investment in the future of your clinical trials. By carefully considering these trends and often-overlooked factors, you can choose a solution that empowers your research, protects your data, and sets you up for success in 2024 and beyond.

 

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