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
- 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
- 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
- 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
- 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
- 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.