ICYMI, Everest Group, a leading global research and consulting firm, named OpenClinica a Major Contender in its Life Sciences Electronic Data Capture (EDC) Products PEAK Matrix® Assessment for 2024.
One of OpenClinica’s key differentiators is our “user-friendly EDC software that requires minimal programming knowledge, featuring single-click publish for mid-study changes, user management, data validation, and query management.”
In other words, OpenClinica empowers our users to build their own studies within our EDC. Our user-friendly EDC software is easy to learn and operate, without much programming knowledge.
Many systems for electronic data capture for clinical trials are not designed for the average data manager to build studies. These systems often require a high level of technical expertise from specialized clinical programmers. On the other hand, systems that data managers may find easy to use are often over simplified, lacking the necessary capability and functionality to run a trial effectively.
OpenClinica gives data managers the best of both worlds: exceptional capabilities and the ability for today’s clinical data managers to deploy them in their studies.
OpenClinica’s Study Designer enables data managers to build studies efficiently without extensive programming knowledge. We continue to invest in our EDC and deploy enhancements to further streamline the study build process, improve collaboration, and ensure compliance.
Building Study Events with Enhanced Calendaring
Study events are the backbone of your trial’s architecture. OpenClinica’s advanced study calendaring module now enables:
- Automated Scheduling: Define rules to automatically schedule, lock, or close visit events based on participant data or time windows.
- Dynamic Updates: Participant calendars update in real-time, reflecting changes instantly.
- Epoch Management: Organize your study into epochs (e.g., screening, treatment, follow-up) for better structure and clarity.
These features ensure that your study remains adaptable to protocol amendments and evolving trial needs.
Seamless Participant Engagement
Recognizing the shift towards decentralized clinical trials, OpenClinica has enhanced its participant-facing tools:
- eConsent Module: Facilitates 21 CFR Part 11-compliant electronic consent, allowing participants to sign forms digitally, with investigators able to countersign as needed.
- OpenClinica Participate™ Enhancements: Participants can now access forms via their own devices, with automated reminders and notifications to improve compliance.
- Integration with Apple Health: For iOS users, background data refresh capabilities allow for seamless data collection from connected health records.
Advanced eCRF Capabilities
OpenClinica’s eCRF tools have evolved to offer:
- Real-Time Edit Checks: Immediate validation to ensure data accuracy at the point of entry.
- Dynamic Logic: Forms that adapt based on previous responses, reducing redundancy and improving user experience.
- Auto-Save Functionality: Eliminates data loss concerns by saving inputs automatically.
- Cross-Form Logic: Enhanced capabilities to reference and utilize data across multiple forms within a study.
Collaborative Study Design
Collaboration is critical to efficient and effective study builds. OpenClinica now offers:
- Real-Time Collaboration: Multiple users can work on the study design simultaneously, with changes reflected instantly.
- Commenting and Review Tools: Facilitate feedback and discussions directly within the Study Designer.
- Version Control: Maintain a comprehensive audit trail of changes, ensuring transparency and compliance.
One-Click Publish and Enhanced Integration
Deploying your study is now more streamlined than ever:
- Single-Click Publishing: Move your study from design to test or production environments instantly.
- EHR Integration with OpenClinica Unite™: Directly pull data from electronic health records (EHRs) into your study, reducing manual data entry and potential errors.
- Single Sign-On (SSO): Simplify user access across OpenClinica solutions, enhancing security and user experience.
Experience the Enhanced OpenClinica EDC
With these advancements, OpenClinica continues to prioritize user-friendly design, robust functionality, and compliance. That’s likely why the Everest Group wrote in their report about the OpenClinica EDC,
OpenClinica’s customers appreciate how the solution allows them to be self-reliant in deploying complex studies, while being able to rely on OpenClinica’s world class infrastructure and team for support, quality, compliance, scalability, reliability, and security.”
Whether you’re a seasoned data manager or new to EDC systems, our platform is designed to support your study’s success.
Learn More about OpenClinica’s EDC: