TrialKit

TrialKit offers a practical solution for transferring data from electronic health records (EHR) or electronic medical records (EMR) to electronic data capture (EDC) systems used in clinical trials. It eliminates the need for costly and complex integrations by providing two flexible methods for data transfer.

Clinical sites often use various EHR and EMR systems, each with unique data structures. Direct integration with EDC systems can be expensive and not scalable. TrialKit addresses this by offering two solutions that allow the use of EHR data in studies without complex service engagements.

Two Methods for EHR to EDC Data Transfer

• TrialKit Bridge: This method allows data transfer from EHR systems to TrialKit eCRFs using PDF files. It supports both structured and unstructured data within PDFs and requires the site or sponsor to provide the document, typically after anonymization. This approach ensures secure and compliant data capture without needing a direct EHR connection.
• EHR Connectivity Through Apple Health: This method supports indirect integration through Apple Health, which connects to major EMR systems like Cerner, Allscripts, and Athena Health. Participants can share authorized data from their Apple Health-connected portals, allowing research teams to access real-world health data and wearable metrics without site-level integration.

These solutions provide several benefits, including reduced manual data entry, enhanced data quality by combining traditional EDC entries with patient-authorized data, and flexibility to use any EHR source that can export data as a PDF. Additionally, they protect patient privacy through built-in anonymization and HIPAA compliance, and improve study efficiency by creating more complete participant profiles with fewer workflow interruptions.

TrialKit's approach aligns with the 21st Century Cures Act's vision for EHR-EDC interoperability and addresses the US FDA's interest in industry collaboration to solve integration challenges. It offers a scalable alternative to direct EHR connections, reducing research costs, improving time to market, and enhancing patient access to new therapies.

FAQs About EHR to EDC

• What does EHR to EDC mean? It refers to transferring data from EHR or EMR systems into EDC systems for clinical research, reducing duplicate entry and improving data consistency.
• What EHR systems can connect with TrialKit? TrialKit can work with any EHR system that exports data in PDF format and can receive data from major EHR vendors through Apple Health.
• Why is direct EHR to EDC integration often not feasible? Each site's EHR requires unique customization, making direct integration expensive and time-consuming. TrialKit provides a scalable alternative.
• Can EHR data be used in decentralized or hybrid trials? Yes, TrialKit's Apple Health connectivity supports remote data sharing, ideal for decentralized and hybrid trials.
• Does Crucial Data Solutions offer EHR integration services? No, but TrialKit allows EHR data use through PDF-based transfer or Apple Health connectivity.