TrialKit EDC

TrialKit EDC is a cloud-native Electronic Data Capture system designed for modern clinical trials, offering flexibility and speed. It supports both traditional and hybrid clinical trials by allowing protocol amendments without downtime and accepting mobile data seamlessly. As the first full-featured EDC platform available as a native mobile app, it caters to traditional, hybrid/decentralized, and fully remote trials.

An EDC system is a digital platform used in clinical trials to collect, manage, and store clinical data, providing real-time, secure data entry and monitoring from any location. TrialKit extends beyond basic data capture, enabling researchers to gather data from sites, patients, or wearable devices anytime, anywhere. It supports decentralized, hybrid, and site-based studies with native mobile apps for iOS, Android, and Mac, distinguishing it from traditional web-only EDC platforms.

Various stakeholders benefit from EDC systems, including Clinical Research Organizations (CROs), pharmaceutical and biotech companies, investigators, academic researchers, sponsors, and study coordinators. TrialKit's flexible licensing, scalability, and comprehensive capabilities make it suitable for organizations of all sizes.

Key Features of TrialKit EDC:

• Flexible Architecture: Adjusts with protocol amendments, allowing easy modifications without downtime.
• Single Sign-On: Provides controlled access to all studies via web or mobile app with one sign-on.
• Easy eCRFs: Drag-and-drop functionality for form design, with options for edit checks and annotated PDFs.
• Form Reusability: Repurpose forms and study builds across multiple accounts, saving time on study setups.
• Secure Site Management: Control permissions and form access rights throughout the system.
• Integrated Query Management: Perform queries via web or mobile app with real-time data updates and audit trails.

TrialKit seamlessly integrates with other products, allowing for direct source data collection, patient-reported outcomes, simplified consent processes, and secure document management. It includes modules for inventory and trial supply management, site payments, blinded adjudication, medical term standardization, and machine-learning API for data transformation. Built-in video conferencing enhances remote assessments and patient retention.