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Top 5 Essential EDC Criteria for Medical Device Trials

Top 5 Considerations in Selecting EDC Platform for Medical Devices in 2024

Rajesh Swamy Pothula
As 2023 wrapped up, medical device clinical research is on the cusp of an exciting new era. While many Electronic Data Capture solutions stem from the pharmaceutical world, they often fail to address the unique needs and challenges of medical device trials. Budget constraints, diverse workflows, and specific regulatory requirements often leave them feeling ill-equipped with the off-the-shelf EDC solutions designed for drug trials. But with a plethora of options available, what should be your top priorities while choosing an EDC platform for a medical device trial?

5 Must-Haves for Your Medical Device EDC Platfrom:

The below list consists of features which a new age EDC must have coupled with medical device 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 Medical Device Data Formats: Ensure the platform 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 medical device studies, following regulations like FDA 21 CFR Part 11, EU MDR/IVDR, and ISO 13485.

4. Powerful Features: Tailored for Medical Devices

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

  • File Attachments: Ensure the EDC system can handle large file sizes associated with medical device data, such as imaging scans and device logs. This avoids manual workarounds and reconciliation headaches and ensures greater privacy.
  • Device-specific features: Ensure the EDC supports efficient reporting of adverse events and serious adverse events specific to medical devices.
  • Maximize Value, Not Costs: Choose an EDC Solution 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

Unleash the full potential of your research with an Electronic Data Capture (EDC) platform designed to empower your team. 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.
  • Pricing Tailored to your Needs: Look for tiered pricing models that consider the duration and size of your studies. Long-term investigations and smaller feasibility studies deserve cost-effective options.
  • 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.

See How our Medical Device EDC can empower
your 2024 trials and beyond!