Using a Novel Wound Care Mhealth Platform as an Integrated Electronic Data Capture (EDC) Solution for Clinical Trials and Post-Market Surveillance

Aim: The aim of this research was to demonstrate the applicability of a proprietary mobile and web-based software platform for integrated electronic data capture (EDC) during clinical trials. Current practice require tedious manual data entry and multiple steps for analysis with third-party applications.

Methods:

1. Automatic image data capture and real-time analysis is facilitated by computer vision and machine learning algorithms.

2. Study coordinators enter input data into the EDC system, which is reviewed and signed off on by a physician.

3. Trial participants are able to report observations remotely via a patient-facing version of the app.

4. Data is captured and analyzed to inform investigator-initiated studies.

Results: Using an integrated wound management platform, product manufacturers and contract research organizations can automatically identify and transmit details of clinical trials. Data from electronic health records (EHR) can be used to further supplement clinical databases for the purpose of improving study design and generating insights on therapy indications. We demonstrate a process where clinical trial data is inputted into a proprietary analytics engine that facilitates real-time feedback on trial status. Metrics such as the number of participants and healing rates at each site can be monitored remotely. The real-time data provided facilitates earlier interventions, faster access to data, data security, compliance, and efficient processes and diminishes the burden of reporting.